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Using a Sober Curious Framework to Explore Barriers and Facilitators to Helping Sexual Minority Women Reduce Alcohol-Related Harms: Protocol for a Descriptive Study.
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-03-03 DOI: 10.2196/63282
Tonda L Hughes, Lauren Bochicchio, Laurie A Drabble, Belinda Lunnay, David Whiteley, Jillian R Scheer, Beth Meadows, Paul Ward, Carol Emslie
<p><strong>Background: </strong>Globally, women consume less alcohol than men, but alcohol consumption among women has declined less in recent years than among men. Drinking rates and alcohol-related harms vary substantially across population groups of women, and sexual minority women (eg, lesbian, bisexual, and queer) are at notably high risk. An emerging body of literature suggests that in addition to minority stress (eg, stigma, discrimination), drinking norms and drinking cultures likely influence sexual minority women's drinking. Almost no research has explored these factors as possible targets of interventions. Sober curiosity is a rapidly growing wellness movement that may be particularly salient for sexual minority women. It encourages individuals to be "curious" about the reasons they choose to drink and alcohol's effects on their life and health.</p><p><strong>Objective: </strong>The aims of this research are to (1) explore the perspectives of the drinking social worlds of sexual minority women, their awareness of the sober curious movement, perceptions of their own and their peers' drinking and desire to drink less, and perceived barriers and facilitations to changing their drinking behaviors and (2) identify key elements of an alcohol reduction intervention tailored for sexual minority women.</p><p><strong>Methods: </strong>We conducted a comprehensive review of the literature on alcohol interventions with sexual minority women. The handful of studies we found paid scant attention to drinking cultures, normative beliefs, or other key elements of sober curiosity. To address the study aims, we are conducting 2 descriptive studies with adult (>18 years) sexual minority women using mixed methods. One includes focus group interviews (n=24-36) and a national survey (n=100-120) with sexual minority women in Scotland. The other includes in-depth interviews (n=18-20) with sexual minority women in the United States. Data from the 2 countries and 3 sources will be analyzed using qualitative and quantitative methods to identify patterns and relationships across data to validate or corroborate findings.</p><p><strong>Results: </strong>Each of the studies received ethics approval in August 2023 and is currently open for recruitment. We anticipate completing data collection in spring 2025. The results of qualitative analyses will be summarized as themes, and results of survey data analyses will be summarized in tables. Findings will be presented to 2 panels of international experts who will assist in identifying critical elements of an alcohol reduction intervention tailored to the unique needs of sexual minority women.</p><p><strong>Conclusions: </strong>With the assistance of the expert panels, we will use Acceptability, Practicability, Effectiveness, Affordability, Side-Effects, and Equity criteria to inform the development of a tailored intervention building on tenants of sober curiosity to assist sexual minority women in reducing harmful drinki
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引用次数: 0
Auricular Acupressure Versus an Intermittent Low-Carbohydrate Diet in Children With Overweight or Obesity With Gastric-Heat and Dampness-Obstruction Syndrome: Protocol for a Randomized Controlled Trial.
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-03-03 DOI: 10.2196/59856
Wen Sun, Jingwei He, Wenqin Wang, Chen Lu, Yating Lin, Yalan Dou, Weili Yan, Jian Yu
<p><strong>Background: </strong>Childhood obesity frequently persists into adulthood and is associated with an increased risk and earlier onset of cardiovascular disease in later life. Behavioral change strategies have been proposed as the first-line weight management approach for children and adolescents with obesity. Nonpharmacological interventions, such as traditional Chinese medicine (TCM) auricular acupressure treatment and intermittent low-carbohydrate diet (ILCD), are increasingly being investigated in the young obese population. However, there is limited high-quality evidence about effectiveness and safety in weight control and reducing cardiometabolic risk in the pediatric population.</p><p><strong>Objective: </strong>This study aimed to compare the effect of cardiometabolic risk reduction between TCM auricular acupressure treatment (TAAT) and ILCD in children with overweight or obesity with gastric-heat and dampness-obstruction syndrome.</p><p><strong>Methods: </strong>This is a randomized controlled trial. Eligible participants are children with overweight or obesity and enrolled at the obesity clinic of the department of TCM at a tertiary children's hospital. Eligible participants must meet the following criteria: (1) be aged between 6 and 18 years, (2) be overweight, and (3) have gastric-heat and dampness-obstruction syndrome. Recruited children will be randomized 3:1 to receive either TAAT or a self-administered ILCD for 1 month: 150 in the TAAT group and 50 in the ILCD group. The primary outcome is the change in body weight from the beginning of treatment to the end of 1 month. Secondary outcomes included body weight, waist circumference, waist-to-height ratio, BMI, blood pressure, body fat content, indexes of liver and renal function, indexes of glucose metabolism, gut microbiota, and TCM syndrome scores at the end of 1 month and 3 months, respectively. Primary statistical analyses were conducted using the intention-to-treat strategy. A generalized linear model was used to compare the difference in weight change between the groups, with the baseline body weight as the covariate, to obtain the estimate of the mean difference in body weight change and its 95% CI, using Gaussian for family function and identity for link function.</p><p><strong>Results: </strong>The study protocol was approved by the institutional ethical committee and registered on ClinicalTrials.gov on May 5, 2023, before recruitment. Recruitment began in June 2023 and is expected to be completed by December 2025. As of November 2024, we have enrolled 112 participants.</p><p><strong>Conclusions: </strong>This randomized controlled trial will provide evidence on the treatment effects and safety of TAAT versus ILCD among children with overweight or obesity with gastric-heat and dampness-obstruction syndrome, in reducing body weight and improving cardiometabolic risks. Exploratory aims include potential underlying mechanisms of the 2 kinds of interventions, based on b
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引用次数: 0
Validation of the Nociception Level Index for the Detection of Nociception and Pain in Critically Ill Adults: Protocol for an Observational Study.
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-28 DOI: 10.2196/60672
Céline Gélinas, Shiva Shahiri T, Han Ting Wang, Maria Cecilia Gallani, Walid Oulehri, Denny Laporta, Philippe Richebé
<p><strong>Background: </strong>In the intensive care unit (ICU), many patients are unable to communicate their pain through self-reporting or behaviors due to their critical care condition, mechanical ventilation, and medication (eg, heavily sedated or chemically paralyzed). Therefore, alternative pain assessment methods are urgently needed for this vulnerable patient population. The Nociception Level (NOL) index is a multiparameter technology initially developed for the monitoring of nociception and related pain in anesthetized patients, and its use in the ICU is new.</p><p><strong>Objective: </strong>This study aims to validate the NOL for the assessment of nociception and related pain in critically ill adults in the ICU. Specific objectives are to examine the ability of the NOL to: (1) detect pain using standard criteria (ie, self-report and behavioral measures), (2) discriminate between nociceptive and nonnociceptive procedures, and (3) generate consistent values when patients are at rest.</p><p><strong>Methods: </strong>The NOL will be monitored in three ICU patient groups: (1) Group A, participants able to self-report their pain (the reference standard criterion using the 0-10 Faces Pain Thermometer) and express behaviors; (2) Group B, participants unable to self-report but able to express behaviors (the alternative standard criterion using the Critical-Care Pain Observation Tool); and (3) Group C, participants unable to self-report and express behaviors. The NOL will be tested before, during, and after two types of standard care procedures: (1) nonnociceptive (eg, cuff inflation to measure blood pressure, soft touch) and (2) nociceptive (eg, tube or drain removal, endotracheal or tracheal suctioning). Receiver operating characteristic curve analysis of the NOL will be performed for Groups A and B using pain standard measures as reference criteria. Mixed linear models for repeated measures will be used to compare time points, procedures, and their interaction in each group (A, B, and C). Based on power analyses and considering an attrition rate of 25%, a total sample size of 146 patients (68 in Group A, 62 in Group B, and 16 in Group C) is targeted.</p><p><strong>Results: </strong>This study was funded in April 2020 but could not be launched until 2022 due to the COVID-19 pandemic. Recruitment and data collection began at the primary site in July 2022 and has been implemented at the secondary sites in 2023 and 2024 and is planned to continue until 2026.</p><p><strong>Conclusions: </strong>The primary strength of this study protocol is that it is based on rigorous validation strategies with the use of pain standard criteria (ie, self-report and behavioral measures). If found to be valid, the NOL could be used as an alternative physiologic measure of pain in critically ill adults for whom no other pain assessment methods are available.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05339737; https://clinicaltrials.gov/study
{"title":"Validation of the Nociception Level Index for the Detection of Nociception and Pain in Critically Ill Adults: Protocol for an Observational Study.","authors":"Céline Gélinas, Shiva Shahiri T, Han Ting Wang, Maria Cecilia Gallani, Walid Oulehri, Denny Laporta, Philippe Richebé","doi":"10.2196/60672","DOIUrl":"https://doi.org/10.2196/60672","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;In the intensive care unit (ICU), many patients are unable to communicate their pain through self-reporting or behaviors due to their critical care condition, mechanical ventilation, and medication (eg, heavily sedated or chemically paralyzed). Therefore, alternative pain assessment methods are urgently needed for this vulnerable patient population. The Nociception Level (NOL) index is a multiparameter technology initially developed for the monitoring of nociception and related pain in anesthetized patients, and its use in the ICU is new.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to validate the NOL for the assessment of nociception and related pain in critically ill adults in the ICU. Specific objectives are to examine the ability of the NOL to: (1) detect pain using standard criteria (ie, self-report and behavioral measures), (2) discriminate between nociceptive and nonnociceptive procedures, and (3) generate consistent values when patients are at rest.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The NOL will be monitored in three ICU patient groups: (1) Group A, participants able to self-report their pain (the reference standard criterion using the 0-10 Faces Pain Thermometer) and express behaviors; (2) Group B, participants unable to self-report but able to express behaviors (the alternative standard criterion using the Critical-Care Pain Observation Tool); and (3) Group C, participants unable to self-report and express behaviors. The NOL will be tested before, during, and after two types of standard care procedures: (1) nonnociceptive (eg, cuff inflation to measure blood pressure, soft touch) and (2) nociceptive (eg, tube or drain removal, endotracheal or tracheal suctioning). Receiver operating characteristic curve analysis of the NOL will be performed for Groups A and B using pain standard measures as reference criteria. Mixed linear models for repeated measures will be used to compare time points, procedures, and their interaction in each group (A, B, and C). Based on power analyses and considering an attrition rate of 25%, a total sample size of 146 patients (68 in Group A, 62 in Group B, and 16 in Group C) is targeted.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;This study was funded in April 2020 but could not be launched until 2022 due to the COVID-19 pandemic. Recruitment and data collection began at the primary site in July 2022 and has been implemented at the secondary sites in 2023 and 2024 and is planned to continue until 2026.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The primary strength of this study protocol is that it is based on rigorous validation strategies with the use of pain standard criteria (ie, self-report and behavioral measures). If found to be valid, the NOL could be used as an alternative physiologic measure of pain in critically ill adults for whom no other pain assessment methods are available.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/strong&gt;ClinicalTrials.gov NCT05339737; https://clinicaltrials.gov/study","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e60672"},"PeriodicalIF":1.4,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143575655","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Antibiotic Use In Utero and Early Life and Risk of Chronic Childhood Conditions in New Zealand: Protocol for a Data Linkage Retrospective Cohort Study.
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-28 DOI: 10.2196/66184
Sharan Ram, Marine Corbin, Andrea 't Mannetje, Amanda Eng, Amanda Kvalsvig, Michael G Baker, Jeroen Douwes

Background: The incidence of many common chronic childhood conditions has increased globally in the past few decades, which has been suggested to be potentially attributed to antibiotic overuse leading to dysbiosis in the gut microbiome.

Objective: This linkage study will assess the role of antibiotic use in utero and in early life in the development of type 1 diabetes (T1D), attention-deficit/hyperactive disorder (ADHD), and inflammatory bowel disease.

Methods: The study design involves several retrospective cohort studies using linked administrative health and social data from Statistics New Zealand's Integrated Data Infrastructure. It uses data from all children who were born in New Zealand between October 2005 and December 2010 (N=334,204) and their mothers. Children's antibiotic use is identified for 4 time periods (at pregnancy, at ≤1 year, at ≤2 years, and at ≤5 years), and the development of T1D, ADHD, and inflammatory bowel disease is measured from the end of the antibiotic use periods until death, emigration, or the end of the follow-up period (2021), whichever came first. Children who emigrated or died before the end of the antibiotic use period are excluded. Cox proportional hazards regression models are used while adjusting for a range of potential confounders.

Results: As of September 2024, data linkage has been completed, involving the integration of antibiotic exposure and outcome variables for 315,789 children. Preliminary analyses show that both prenatal and early life antibiotic consumption is associated with T1D. Full analyses for all 3 outcomes will be completed by the end of 2025.

Conclusions: This series of linked cohort studies using detailed, complete, and systematically collected antibiotic prescription data will provide critical new knowledge regarding the role of antibiotics in the development of common chronic childhood conditions. Thus, this study has the potential to contribute to the development of primary prevention strategies through, for example, targeted changes in antibiotic use.

International registered report identifier (irrid): DERR1-10.2196/66184.

{"title":"Antibiotic Use In Utero and Early Life and Risk of Chronic Childhood Conditions in New Zealand: Protocol for a Data Linkage Retrospective Cohort Study.","authors":"Sharan Ram, Marine Corbin, Andrea 't Mannetje, Amanda Eng, Amanda Kvalsvig, Michael G Baker, Jeroen Douwes","doi":"10.2196/66184","DOIUrl":"https://doi.org/10.2196/66184","url":null,"abstract":"<p><strong>Background: </strong>The incidence of many common chronic childhood conditions has increased globally in the past few decades, which has been suggested to be potentially attributed to antibiotic overuse leading to dysbiosis in the gut microbiome.</p><p><strong>Objective: </strong>This linkage study will assess the role of antibiotic use in utero and in early life in the development of type 1 diabetes (T1D), attention-deficit/hyperactive disorder (ADHD), and inflammatory bowel disease.</p><p><strong>Methods: </strong>The study design involves several retrospective cohort studies using linked administrative health and social data from Statistics New Zealand's Integrated Data Infrastructure. It uses data from all children who were born in New Zealand between October 2005 and December 2010 (N=334,204) and their mothers. Children's antibiotic use is identified for 4 time periods (at pregnancy, at ≤1 year, at ≤2 years, and at ≤5 years), and the development of T1D, ADHD, and inflammatory bowel disease is measured from the end of the antibiotic use periods until death, emigration, or the end of the follow-up period (2021), whichever came first. Children who emigrated or died before the end of the antibiotic use period are excluded. Cox proportional hazards regression models are used while adjusting for a range of potential confounders.</p><p><strong>Results: </strong>As of September 2024, data linkage has been completed, involving the integration of antibiotic exposure and outcome variables for 315,789 children. Preliminary analyses show that both prenatal and early life antibiotic consumption is associated with T1D. Full analyses for all 3 outcomes will be completed by the end of 2025.</p><p><strong>Conclusions: </strong>This series of linked cohort studies using detailed, complete, and systematically collected antibiotic prescription data will provide critical new knowledge regarding the role of antibiotics in the development of common chronic childhood conditions. Thus, this study has the potential to contribute to the development of primary prevention strategies through, for example, targeted changes in antibiotic use.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/66184.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e66184"},"PeriodicalIF":1.4,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143575875","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Correction: Methodology for the Positive Voices 2022 Survey of People With HIV Accessing Care in England, Wales, and Scotland: Cross-Sectional Questionnaire Study.
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-27 DOI: 10.2196/72512
Janey Sewell, Carole Kelly, Adamma Aghaizu, Hannah Kitt, Annegret Pelchen-Matthews, Veronique Martin, Amal Farah, Colette Smith, Alison Brown, Clare Humphreys, Alex Sparrowhawk, Valerie Delpech, Alison Rodger, Fiona Lampe, Meaghan Kall

[This corrects the article DOI: 10.2196/58531.].

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引用次数: 0
Assessing Preparedness for Self-Management of Oral Anticoagulation in Adults With the PERSONAE Scale: Protocol for a Development and Validation Study.
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-26 DOI: 10.2196/51502
Rosario Caruso, Gianluca Conte, Serenella Castelvecchio, Irene Baroni, Giulia Paglione, Giada De Angeli, Malgorzata Pasek, Arianna Magon
<p><strong>Background: </strong>Optimal anticoagulation using vitamin K antagonists prevents strokes associated with atrial fibrillation and heart valve replacements. Preparedness for self-monitoring and self-management could improve outcomes, but this remains a challenge.</p><p><strong>Objective: </strong>This study aimed to outline the methodology for developing and validating the PERSONAE scale, a self-report measure designed to assess the preparedness for self-monitoring and self-management of oral anticoagulation in adult patients.</p><p><strong>Methods: </strong>This study comprises 2 main phases, and it adheres to the "COnsensus-based Standards for the selection of health Measurement INstruments" (COSMIN) guidelines for instrument development. The first phase involved the conceptualization of the PERSONAE scale, where a comprehensive literature review and a consensus meeting among experts were conducted to draft the initial items. Face and content validity were then established through an expert panel review. In the second phase (ongoing), a detailed sampling methodology will be used, targeting adult Italian patients on long-term oral anticoagulation. According to a performed simulation-based power analysis, the study aims to recruit a sample size of approximately 500 participants by using a combination of convenience and snowball sampling. Data collection will be facilitated through web-based surveys distributed through social media and patient networks, ensuring a wide and representative sample. Analytical procedures will include Mokken scaling analysis for item selection and confirmatory factor analysis to validate the scale's structure. In addition, internal consistency will be assessed using Molenaar Sijtsma statistics.</p><p><strong>Results: </strong>The scale's content derived from phase 1 (process completed in December 2023) is grounded in a comprehensive literature review and based on the assessments of a panel of 12 health care expert professionals. The PERSONAE scale derived from phase 1 encompasses 20 items reflecting essential behaviors needed to assess the preparedness for self-monitoring and self-management of oral anticoagulation. Each item obtained a content validity ratio higher than 0.67, which is the critical content validity ratio indicating the minimum level of agreement among the experts for an item to be considered essential beyond the level of chance at a significance level of .05 for a 1-tailed test. From January 2024 to May 2024, we conducted the initial round of data collection and use Mokken scaling analysis to select items. A second round of data collection for confirmatory factor analysis was scheduled from June 2024 to September 2024, which will validate the scale's unidimensional structure. We expect to achieve robust psychometric properties, including high internal consistency and validated constructs.</p><p><strong>Conclusions: </strong>The PERSONAE scale will be a valuable tool to assess patients' prepar
{"title":"Assessing Preparedness for Self-Management of Oral Anticoagulation in Adults With the PERSONAE Scale: Protocol for a Development and Validation Study.","authors":"Rosario Caruso, Gianluca Conte, Serenella Castelvecchio, Irene Baroni, Giulia Paglione, Giada De Angeli, Malgorzata Pasek, Arianna Magon","doi":"10.2196/51502","DOIUrl":"https://doi.org/10.2196/51502","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Optimal anticoagulation using vitamin K antagonists prevents strokes associated with atrial fibrillation and heart valve replacements. Preparedness for self-monitoring and self-management could improve outcomes, but this remains a challenge.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aimed to outline the methodology for developing and validating the PERSONAE scale, a self-report measure designed to assess the preparedness for self-monitoring and self-management of oral anticoagulation in adult patients.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This study comprises 2 main phases, and it adheres to the \"COnsensus-based Standards for the selection of health Measurement INstruments\" (COSMIN) guidelines for instrument development. The first phase involved the conceptualization of the PERSONAE scale, where a comprehensive literature review and a consensus meeting among experts were conducted to draft the initial items. Face and content validity were then established through an expert panel review. In the second phase (ongoing), a detailed sampling methodology will be used, targeting adult Italian patients on long-term oral anticoagulation. According to a performed simulation-based power analysis, the study aims to recruit a sample size of approximately 500 participants by using a combination of convenience and snowball sampling. Data collection will be facilitated through web-based surveys distributed through social media and patient networks, ensuring a wide and representative sample. Analytical procedures will include Mokken scaling analysis for item selection and confirmatory factor analysis to validate the scale's structure. In addition, internal consistency will be assessed using Molenaar Sijtsma statistics.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The scale's content derived from phase 1 (process completed in December 2023) is grounded in a comprehensive literature review and based on the assessments of a panel of 12 health care expert professionals. The PERSONAE scale derived from phase 1 encompasses 20 items reflecting essential behaviors needed to assess the preparedness for self-monitoring and self-management of oral anticoagulation. Each item obtained a content validity ratio higher than 0.67, which is the critical content validity ratio indicating the minimum level of agreement among the experts for an item to be considered essential beyond the level of chance at a significance level of .05 for a 1-tailed test. From January 2024 to May 2024, we conducted the initial round of data collection and use Mokken scaling analysis to select items. A second round of data collection for confirmatory factor analysis was scheduled from June 2024 to September 2024, which will validate the scale's unidimensional structure. We expect to achieve robust psychometric properties, including high internal consistency and validated constructs.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The PERSONAE scale will be a valuable tool to assess patients' prepar","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e51502"},"PeriodicalIF":1.4,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143515717","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Weighted Blankets for Agitation in Hospitalized Patients with Dementia: Protocol for a Randomized Controlled Trial.
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-26 DOI: 10.2196/57264
Holly A Schenzel, Allyson K Palmer, Neel B Shah, Donna K Lawson, Karen M Fischer, Maria I Lapid, Ruth E DeFoster
<p><strong>Background: </strong>There are limited therapies approved for the treatment of aggression and agitation in patients with dementia. While antipsychotics and benzodiazepines are commonly used, these medications have been associated with significant side effects and US Food and Drug Administration (FDA) boxed warnings. Weighted blankets have been associated with decreased anxiety and improved sleep. Weighted blankets are potentially a nonpharmacologic option to reduce agitation in hospitalized patients with dementia.</p><p><strong>Objective: </strong>The aim of this study is to investigate the effect of weighted blankets on aggression and agitation in hospitalized patients with dementia.</p><p><strong>Methods: </strong>A pilot study will be conducted on a total of 30 hospitalized patients with a documented clinical diagnosis of dementia and ongoing agitated behaviors admitted to a medicine or psychiatry service. Patients will be randomly allocated to receive either a weighted blanket for 3 nights or continued usual care. The primary outcome is the change in the observational version of the Cohen-Mansfield Agitation Inventory (CMAI-O) over the course of the 3-night study period. The secondary outcomes are changes in Edmonton Symptom Assessment System Revised (ESAS-r) and Clinical Global Impression (CGI) scores, hours of sleep, use of antipsychotics and benzodiazepines, and incidence of delirium. Identical study assessments will be completed for both the usual care and the weighted blanket study groups. At 5 study time points (baseline, postnight 1, postnight 2, postnight 3, and a final assessment 48-72 h after the last use of the weighted blanket), patients will be assessed with the CMAI-O, ESAS-r, and CGI tools. All assessments will be completed by the bedside nurse or patient care assistant caring for the patient each day. Within 2 to 4 weeks post discharge from the hospital, study coordinators will contact the patient's legally authorized representative (LAR) to assess for continued use of the weighted blanket.</p><p><strong>Results: </strong>Enrollment of participants began on April 23, 2023. As of November 2024, a total of 24 participants have been enrolled in the study. Baseline characteristics of enrolled participants will be analyzed and reported upon completion of enrollment. We anticipate completing data collection by March 2026.</p><p><strong>Conclusions: </strong>The study will determine the effect of weighted blankets on agitation in hospitalized patients with dementia. Insights into the effect of weighted blankets on sleep will also be gained. The results of this study will be relevant in the setting of increasing numbers of older adults with dementia exhibiting agitation, leading to increased hospitalizations, caregiver burden, and health care costs.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT03643991; http://clinicaltrials.gov/ct2/show/NCT03643991.</p><p><strong>International registered report identifi
{"title":"Weighted Blankets for Agitation in Hospitalized Patients with Dementia: Protocol for a Randomized Controlled Trial.","authors":"Holly A Schenzel, Allyson K Palmer, Neel B Shah, Donna K Lawson, Karen M Fischer, Maria I Lapid, Ruth E DeFoster","doi":"10.2196/57264","DOIUrl":"https://doi.org/10.2196/57264","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;There are limited therapies approved for the treatment of aggression and agitation in patients with dementia. While antipsychotics and benzodiazepines are commonly used, these medications have been associated with significant side effects and US Food and Drug Administration (FDA) boxed warnings. Weighted blankets have been associated with decreased anxiety and improved sleep. Weighted blankets are potentially a nonpharmacologic option to reduce agitation in hospitalized patients with dementia.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The aim of this study is to investigate the effect of weighted blankets on aggression and agitation in hospitalized patients with dementia.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A pilot study will be conducted on a total of 30 hospitalized patients with a documented clinical diagnosis of dementia and ongoing agitated behaviors admitted to a medicine or psychiatry service. Patients will be randomly allocated to receive either a weighted blanket for 3 nights or continued usual care. The primary outcome is the change in the observational version of the Cohen-Mansfield Agitation Inventory (CMAI-O) over the course of the 3-night study period. The secondary outcomes are changes in Edmonton Symptom Assessment System Revised (ESAS-r) and Clinical Global Impression (CGI) scores, hours of sleep, use of antipsychotics and benzodiazepines, and incidence of delirium. Identical study assessments will be completed for both the usual care and the weighted blanket study groups. At 5 study time points (baseline, postnight 1, postnight 2, postnight 3, and a final assessment 48-72 h after the last use of the weighted blanket), patients will be assessed with the CMAI-O, ESAS-r, and CGI tools. All assessments will be completed by the bedside nurse or patient care assistant caring for the patient each day. Within 2 to 4 weeks post discharge from the hospital, study coordinators will contact the patient's legally authorized representative (LAR) to assess for continued use of the weighted blanket.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Enrollment of participants began on April 23, 2023. As of November 2024, a total of 24 participants have been enrolled in the study. Baseline characteristics of enrolled participants will be analyzed and reported upon completion of enrollment. We anticipate completing data collection by March 2026.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The study will determine the effect of weighted blankets on agitation in hospitalized patients with dementia. Insights into the effect of weighted blankets on sleep will also be gained. The results of this study will be relevant in the setting of increasing numbers of older adults with dementia exhibiting agitation, leading to increased hospitalizations, caregiver burden, and health care costs.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/strong&gt;ClinicalTrials.gov NCT03643991; http://clinicaltrials.gov/ct2/show/NCT03643991.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;International registered report identifi","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e57264"},"PeriodicalIF":1.4,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143515722","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Developing and Evaluating an Interactive, Case-Based, Web-Based Active Learning Tool for Primary Care Physicians (Community Fracture Capture Learning Hub): Protocol for an Acceptability and Engagement Study. 为初级保健医生开发和评估基于案例的网络互动式主动学习工具(社区骨折捕获学习中心):可接受性和参与度研究协议》。
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-25 DOI: 10.2196/57511
Ahmed M Fathalla, Cherie Chiang, Ralph Audehm, Alexandra Gorelik, Shanton Chang, Christopher J Yates, Steve Snow, Rahul Barmanray, Sarah Price, Lucy Collins, John D Wark
<p><strong>Background: </strong>The lack of osteoporosis treatment initiation after fragility fractures is a significant gap, especially in primary care. It is unclear whether barriers for primary care physicians (PCPs) arise from uncertainty about investigations, treatment initiation, or medication side effects. Key questions remain about whether active learning platforms improve treatment initiation rates better than passive methods and how PCP demographics affect learning outcomes. With PCPs increasingly using web-based platforms for continuing professional development due to time constraints and heavy workloads, an interactive community fracture capture (CFC) tool may serve as an effective alternative to in-person learning. Our CFC pilot study tested this new program's design and content, showing promising potential.</p><p><strong>Objective: </strong>We aim to evaluate the interactive, case-based, web-based CFC Learning Hub, examining user acceptance and engagement with the platform, focusing on participants' interactions, satisfaction levels, and overall experience.</p><p><strong>Methods: </strong>Participating PCPs are recruited through Praxhub, a web-based medical education platform, and provide electronic consent for data use after deidentification. They have been allocated into small groups (12-20 members) and join the CFC Learning Hub, a secure web-based community. This hub includes a web-based discussion forum with participant-contributed case studies and a knowledge repository. Over the 6-week program, participants will receive weekly modules with instructions, resources, discussion threads, and quizzes, along with interactive discussions moderated by experienced PCPs and physicians. The platform also hosts web-based surveys that, in combination with platform analytics, allow assessment of baseline knowledge gaps, level of activity or engagement, and improvements following the course completion. This study protocol demonstrates the creation and proposed evaluation of the CFC Learning Hub, featuring an interactive, case-based, small-group web-based learning platform equipped with flexibly scheduled, tailored modules to address the fracture treatment gap within the community. Both qualitative (via thematic analysis) and quantitative (by using 2-tailed paired t tests, Wilcoxon signed rank tests, and multivariable regression analysis) analyses will be used to assess levels of engagement and acceptance and changes in PCPs' knowledge and confidence after engagement with the CFC Learning Hub.</p><p><strong>Results: </strong>Recruitment of participants started in May 2022. Data collection, analysis, and reporting will be completed following the completion of four 6-week cycles of the program.</p><p><strong>Conclusions: </strong>The study described in this protocol will provide important insights into the function and effectiveness of the CFC Learning Hub. This information will guide the expansion of the program. This initiative offers a simpl
{"title":"Developing and Evaluating an Interactive, Case-Based, Web-Based Active Learning Tool for Primary Care Physicians (Community Fracture Capture Learning Hub): Protocol for an Acceptability and Engagement Study.","authors":"Ahmed M Fathalla, Cherie Chiang, Ralph Audehm, Alexandra Gorelik, Shanton Chang, Christopher J Yates, Steve Snow, Rahul Barmanray, Sarah Price, Lucy Collins, John D Wark","doi":"10.2196/57511","DOIUrl":"https://doi.org/10.2196/57511","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The lack of osteoporosis treatment initiation after fragility fractures is a significant gap, especially in primary care. It is unclear whether barriers for primary care physicians (PCPs) arise from uncertainty about investigations, treatment initiation, or medication side effects. Key questions remain about whether active learning platforms improve treatment initiation rates better than passive methods and how PCP demographics affect learning outcomes. With PCPs increasingly using web-based platforms for continuing professional development due to time constraints and heavy workloads, an interactive community fracture capture (CFC) tool may serve as an effective alternative to in-person learning. Our CFC pilot study tested this new program's design and content, showing promising potential.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;We aim to evaluate the interactive, case-based, web-based CFC Learning Hub, examining user acceptance and engagement with the platform, focusing on participants' interactions, satisfaction levels, and overall experience.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Participating PCPs are recruited through Praxhub, a web-based medical education platform, and provide electronic consent for data use after deidentification. They have been allocated into small groups (12-20 members) and join the CFC Learning Hub, a secure web-based community. This hub includes a web-based discussion forum with participant-contributed case studies and a knowledge repository. Over the 6-week program, participants will receive weekly modules with instructions, resources, discussion threads, and quizzes, along with interactive discussions moderated by experienced PCPs and physicians. The platform also hosts web-based surveys that, in combination with platform analytics, allow assessment of baseline knowledge gaps, level of activity or engagement, and improvements following the course completion. This study protocol demonstrates the creation and proposed evaluation of the CFC Learning Hub, featuring an interactive, case-based, small-group web-based learning platform equipped with flexibly scheduled, tailored modules to address the fracture treatment gap within the community. Both qualitative (via thematic analysis) and quantitative (by using 2-tailed paired t tests, Wilcoxon signed rank tests, and multivariable regression analysis) analyses will be used to assess levels of engagement and acceptance and changes in PCPs' knowledge and confidence after engagement with the CFC Learning Hub.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Recruitment of participants started in May 2022. Data collection, analysis, and reporting will be completed following the completion of four 6-week cycles of the program.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The study described in this protocol will provide important insights into the function and effectiveness of the CFC Learning Hub. This information will guide the expansion of the program. This initiative offers a simpl","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e57511"},"PeriodicalIF":1.4,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143501398","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Effectiveness of Text Messaging Nudging to Increase Coverage of Influenza Vaccination Among Older Adults in Norway (InfluSMS Study): Protocol for a Randomized Controlled Trial.
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-25 DOI: 10.2196/63938
Bo T Hansen, Ole Klungsøyr, Angela S Labberton, Lauri Sääksvuori, Kjersti M Rydland, Liz E Ødeskaug, Torbjørn Wisløff, Hinta Meijerink
<p><strong>Background: </strong>The coverage of influenza vaccination among older adults in Norway is insufficient, especially in some immigrant groups. To improve public health, there is a need for an intervention that can increase influenza vaccination coverage. Further, interventions tailored to reduce potential barriers among immigrants can reduce health inequities.</p><p><strong>Objective: </strong>InfluSMS aims to determine if SMS nudging increases vaccination coverage among those aged 65 years or older (1) in Norway's general population; (2) among immigrants born in Poland; and (3) among immigrants born in Ukraine; and evaluate the impact of SMS nudging in Norwegian versus in the official language of the native country of immigrants born in Poland or Ukraine.</p><p><strong>Methods: </strong>InfluSMS is a pragmatic randomized controlled trial conducted among people aged 65 years or older residing in Norway. Influenza vaccination coverage is the main outcome, measured in control and intervention arms for each of the 3 populations listed earlier. In all 3 populations, the control arm is standard care, that is, no individual reminder for influenza vaccination. All populations have an intervention arm that will receive an SMS nudge in the Norwegian language. In addition, the Polish and Ukrainian immigrant populations include a second intervention arm that will receive an SMS nudge in Polish or Ukrainian, respectively. In the general population, at least 23,485 individuals will be randomized to the SMS intervention arm while the rest of the population constitutes the control arm. In each of the 2 immigrant populations, we will randomize all eligible individuals 1:1:1 into the 3 arms. The intervention will take place at the start of the 2025-2026 influenza season. All eligible individuals will be passively followed up through the National Immunisation Registry, SYSVAK, from which individual influenza vaccination status 3 months after the SMS nudge will be collected. Coverage rates between arms within each population and effect sizes between the populations will be compared. The cost-effectiveness of SMS nudging will also be assessed.</p><p><strong>Results: </strong>The inclusion of participants will start in the third quarter of 2025, and the registry data will be available in the first quarter of 2026. Coverage rates of each strategy and coverage differences between strategies will be presented.</p><p><strong>Conclusions: </strong>SMS nudging is a scalable, inexpensive, and nonintrusive intervention that could be integrated into the national influenza vaccination program if the trial shows it effectively increases influenza vaccination coverage among older adults. Further, the trial will establish whether language is a barrier to influenza vaccination uptake among recent immigrant groups that have low influenza vaccination coverage, and to what extent this potential barrier can be diminished by SMS nudging in the official language of their nativ
{"title":"Effectiveness of Text Messaging Nudging to Increase Coverage of Influenza Vaccination Among Older Adults in Norway (InfluSMS Study): Protocol for a Randomized Controlled Trial.","authors":"Bo T Hansen, Ole Klungsøyr, Angela S Labberton, Lauri Sääksvuori, Kjersti M Rydland, Liz E Ødeskaug, Torbjørn Wisløff, Hinta Meijerink","doi":"10.2196/63938","DOIUrl":"10.2196/63938","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The coverage of influenza vaccination among older adults in Norway is insufficient, especially in some immigrant groups. To improve public health, there is a need for an intervention that can increase influenza vaccination coverage. Further, interventions tailored to reduce potential barriers among immigrants can reduce health inequities.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;InfluSMS aims to determine if SMS nudging increases vaccination coverage among those aged 65 years or older (1) in Norway's general population; (2) among immigrants born in Poland; and (3) among immigrants born in Ukraine; and evaluate the impact of SMS nudging in Norwegian versus in the official language of the native country of immigrants born in Poland or Ukraine.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;InfluSMS is a pragmatic randomized controlled trial conducted among people aged 65 years or older residing in Norway. Influenza vaccination coverage is the main outcome, measured in control and intervention arms for each of the 3 populations listed earlier. In all 3 populations, the control arm is standard care, that is, no individual reminder for influenza vaccination. All populations have an intervention arm that will receive an SMS nudge in the Norwegian language. In addition, the Polish and Ukrainian immigrant populations include a second intervention arm that will receive an SMS nudge in Polish or Ukrainian, respectively. In the general population, at least 23,485 individuals will be randomized to the SMS intervention arm while the rest of the population constitutes the control arm. In each of the 2 immigrant populations, we will randomize all eligible individuals 1:1:1 into the 3 arms. The intervention will take place at the start of the 2025-2026 influenza season. All eligible individuals will be passively followed up through the National Immunisation Registry, SYSVAK, from which individual influenza vaccination status 3 months after the SMS nudge will be collected. Coverage rates between arms within each population and effect sizes between the populations will be compared. The cost-effectiveness of SMS nudging will also be assessed.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The inclusion of participants will start in the third quarter of 2025, and the registry data will be available in the first quarter of 2026. Coverage rates of each strategy and coverage differences between strategies will be presented.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;SMS nudging is a scalable, inexpensive, and nonintrusive intervention that could be integrated into the national influenza vaccination program if the trial shows it effectively increases influenza vaccination coverage among older adults. Further, the trial will establish whether language is a barrier to influenza vaccination uptake among recent immigrant groups that have low influenza vaccination coverage, and to what extent this potential barrier can be diminished by SMS nudging in the official language of their nativ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e63938"},"PeriodicalIF":1.4,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143492155","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Contactless Breathing Monitoring at Home and in the Hospital: Protocol for a Low-Cost Frequency-Modulated Continuous-Wave Radar-Based Device.
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-25 DOI: 10.2196/59532
Arnav Hari, Ravishankar Kumar, Brijesh Kumbhani, Sam Darshi, Satyam Agarwal, Jyotindra Singh Sahambi, Suksham Jain, Deepak Chawla

Background: Contactless monitoring of vital signs, especially the breathing of children, in the hospital is performed on a priority basis because their organs and immune system are immature. Therefore, continuous monitoring of their vital signs with a sensor that is directly attached to their body is not possible, as it irritates the sensitive newborn skin and causes discomfort. A contactless frequency-modulated continuous-wave (FMCW) radar-based device can wirelessly monitor the breathing rate and pattern of a child in the hospital or at home. Signal-processing capability can be added to this device to process breathing data and analyze the apnea condition arising due to irregular breathing patterns.

Objective: This study will develop a contactless FMCW radar-based system to accurately monitor the breathing rate and pattern of neonates and infants in hospitals and at home in order to provide a noninvasive, nonintrusive and contactless alternative to conventional sensor-based methods and address a critical need in neonatal care, potentially improving health outcomes for vulnerable infants.

Methods: The radar transmits a signal toward the body, and the time taken by the signal received to travel from the body to the receiving antenna is analyzed. This time is proportional to the distance between the radar and the body, and the breathing pattern is recognized as a slight, periodic variation in this distance. We will use this concept with multiple antenna systems to monitor the breathing of neonates with improved sensitivity. The radar-based device will be installed, in addition to conventional breathing monitors, in the neonatal intensive care unit. The signals received at the radar and the respiration signals from conventional monitors will be recorded in a database. Signal-processing techniques will be applied to extract breathing signals from the signals received at the radar.

Results: This study was funded in January 2023 by the Science and Engineering Research Board (SERB) of India. The device was designed by May 2024, and a working proof-of concept was verified in the Indian Institute of Technology (IIT) Ropar laboratory. Implementation of the proposed method for initial study began in December 2024. Results are expected to be published in the first quarter of 2025.

Conclusions: The contactless FMCW radar-based system will provide reliable estimation of the breathing rate and pattern, which is close to the conventional reference device values most of the time. Our device will also provide a seamless breathing-monitoring system to be used both in hospitals and at home for newborns and premature babies until they are fully healthy and fit.

International registered report identifier (irrid): PRR1-10.2196/59532.

{"title":"Contactless Breathing Monitoring at Home and in the Hospital: Protocol for a Low-Cost Frequency-Modulated Continuous-Wave Radar-Based Device.","authors":"Arnav Hari, Ravishankar Kumar, Brijesh Kumbhani, Sam Darshi, Satyam Agarwal, Jyotindra Singh Sahambi, Suksham Jain, Deepak Chawla","doi":"10.2196/59532","DOIUrl":"https://doi.org/10.2196/59532","url":null,"abstract":"<p><strong>Background: </strong>Contactless monitoring of vital signs, especially the breathing of children, in the hospital is performed on a priority basis because their organs and immune system are immature. Therefore, continuous monitoring of their vital signs with a sensor that is directly attached to their body is not possible, as it irritates the sensitive newborn skin and causes discomfort. A contactless frequency-modulated continuous-wave (FMCW) radar-based device can wirelessly monitor the breathing rate and pattern of a child in the hospital or at home. Signal-processing capability can be added to this device to process breathing data and analyze the apnea condition arising due to irregular breathing patterns.</p><p><strong>Objective: </strong>This study will develop a contactless FMCW radar-based system to accurately monitor the breathing rate and pattern of neonates and infants in hospitals and at home in order to provide a noninvasive, nonintrusive and contactless alternative to conventional sensor-based methods and address a critical need in neonatal care, potentially improving health outcomes for vulnerable infants.</p><p><strong>Methods: </strong>The radar transmits a signal toward the body, and the time taken by the signal received to travel from the body to the receiving antenna is analyzed. This time is proportional to the distance between the radar and the body, and the breathing pattern is recognized as a slight, periodic variation in this distance. We will use this concept with multiple antenna systems to monitor the breathing of neonates with improved sensitivity. The radar-based device will be installed, in addition to conventional breathing monitors, in the neonatal intensive care unit. The signals received at the radar and the respiration signals from conventional monitors will be recorded in a database. Signal-processing techniques will be applied to extract breathing signals from the signals received at the radar.</p><p><strong>Results: </strong>This study was funded in January 2023 by the Science and Engineering Research Board (SERB) of India. The device was designed by May 2024, and a working proof-of concept was verified in the Indian Institute of Technology (IIT) Ropar laboratory. Implementation of the proposed method for initial study began in December 2024. Results are expected to be published in the first quarter of 2025.</p><p><strong>Conclusions: </strong>The contactless FMCW radar-based system will provide reliable estimation of the breathing rate and pattern, which is close to the conventional reference device values most of the time. Our device will also provide a seamless breathing-monitoring system to be used both in hospitals and at home for newborns and premature babies until they are fully healthy and fit.</p><p><strong>International registered report identifier (irrid): </strong>PRR1-10.2196/59532.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e59532"},"PeriodicalIF":1.4,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143501396","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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JMIR Research Protocols
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