Pub Date : 2016-10-01DOI: 10.4103/2468-5577.193147
J. Pannek, S. Pannek-Rademacher, M. Jus, J. Krebs
Background: Virtually many patients with spinal cord injury (SCI) suffer from neurogenic lower urinary tract dysfunction (NLUTD). Although the most severe consequence of NLUTD, damage of renal function, can be treated effectively today, urinary tract infections (UTI) are the most common urologic problems in SCI patients. They severely impair the quality of life, and no evidence-based prophylaxis exists. The goal of this study is to assess the usefulness of adjunctive homeopathic treatment for the reduction of UTI in patients with SCI. Methods/Design: A prospective randomized controlled trial is designed to assess whether adjunctive treatment with classical homeopathy leads to a relevant reduction of the rate of UTI in patients with SCI. In addition, it will be assessed if homeopathic treatment will significantly improve patient satisfaction and quality of life. Fifty patients with SCI and recurrent (3 or more) UTI per year will be recruited from the patients of the neuro-urology of the Swiss paraplegic Centre in Nottwil, Switzerland. All patients will be randomly allocated into two groups: patients in the homeopathy group (n = 25) will receive standard of-care prophylaxis combined with homeopathic treatment; the control group (n = 25) will receive standard of-care prophylaxis alone. Standard of-care prophylaxis consists of cranberry products and urine acidification. Homeopathic treatment consists of a homeopathic medication; the remedy is chosen individually based on the homeopathic case taking. Patients do not routinely present to the homeopaths during the study, but can contact them if a UTI occurs during the course of the study. Primary outcome are the UTI rate, and secondary outcomes are quality of life and satisfaction with the treatment over a follow-up period of 1 year. Discussion: There is a high demand for effective UTI prophylaxis in patients with SCI, because UTI are associated with an increased morbidity and even mortality. The results of the study will significantly add to our knowledge not only about UTI prevention, but the clinical value of homeopathy. Trial registration: ClinicalTrials.gov identifier: NCT01477502, registered on 17 November 2011. Ethics: The "Ethikkommission Nordwest- und Zentralschweiz (EKNZ): PB_2016-00054" approved this study protocol. Informed consent: Patients will sign an informed consent prior to participation in the study.
{"title":"Homeopathic prophylaxis for recurrent urinary tract infections following spinal cord injury: study protocol for a randomized controlled trial","authors":"J. Pannek, S. Pannek-Rademacher, M. Jus, J. Krebs","doi":"10.4103/2468-5577.193147","DOIUrl":"https://doi.org/10.4103/2468-5577.193147","url":null,"abstract":"Background: Virtually many patients with spinal cord injury (SCI) suffer from neurogenic lower urinary tract dysfunction (NLUTD). Although the most severe consequence of NLUTD, damage of renal function, can be treated effectively today, urinary tract infections (UTI) are the most common urologic problems in SCI patients. They severely impair the quality of life, and no evidence-based prophylaxis exists. The goal of this study is to assess the usefulness of adjunctive homeopathic treatment for the reduction of UTI in patients with SCI. Methods/Design: A prospective randomized controlled trial is designed to assess whether adjunctive treatment with classical homeopathy leads to a relevant reduction of the rate of UTI in patients with SCI. In addition, it will be assessed if homeopathic treatment will significantly improve patient satisfaction and quality of life. Fifty patients with SCI and recurrent (3 or more) UTI per year will be recruited from the patients of the neuro-urology of the Swiss paraplegic Centre in Nottwil, Switzerland. All patients will be randomly allocated into two groups: patients in the homeopathy group (n = 25) will receive standard of-care prophylaxis combined with homeopathic treatment; the control group (n = 25) will receive standard of-care prophylaxis alone. Standard of-care prophylaxis consists of cranberry products and urine acidification. Homeopathic treatment consists of a homeopathic medication; the remedy is chosen individually based on the homeopathic case taking. Patients do not routinely present to the homeopaths during the study, but can contact them if a UTI occurs during the course of the study. Primary outcome are the UTI rate, and secondary outcomes are quality of life and satisfaction with the treatment over a follow-up period of 1 year. Discussion: There is a high demand for effective UTI prophylaxis in patients with SCI, because UTI are associated with an increased morbidity and even mortality. The results of the study will significantly add to our knowledge not only about UTI prevention, but the clinical value of homeopathy. Trial registration: ClinicalTrials.gov identifier: NCT01477502, registered on 17 November 2011. Ethics: The \"Ethikkommission Nordwest- und Zentralschweiz (EKNZ): PB_2016-00054\" approved this study protocol. Informed consent: Patients will sign an informed consent prior to participation in the study.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78555185","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}
Pub Date : 2016-10-01DOI: 10.4103/2468-5577.193144
Wei Lin, Likun Yang, Sang Cai, Jie Zhu, Yi Feng, Li-xiang Yang, Zhi-zhong Feng, Peipei Li, Junhui Chen, Yuhai Wang
Background: Traumatic brain injury is a high-incidence condition that can cause severe cognitive impairment. At present, functional magnetic resonance imaging is used to analyze changes in brain function and network connectivity at different stages of injury. In addition, tau protein expression in nerve cells may reflect cognitive function. However, the combined use of functional magnetic resonance imaging and tau measurement to assess cognitive function following traumatic brain injury has not yet been investigated. Methods/Design: A prospective inception cohort study will be performed at the 101 st Hospital of PLA, Wuxi, China. We will conduct a follow-up visit in 100 patients with traumatic brain injury. Cognitive function will be assessed within 24 hours of injury and 0.5, 1, and 2 years after injury. Primary outcomes will be the Montreal Cognitive Assessment score, functional magnetic resonance imaging results, and tau protein level in the cerebrospinal fluid. Secondary outcomes will include Mini-Mental State Examination Scale and Hamilton Depression Scale scores. We will assess cognitive function in patients with traumatic brain injury and analyze its correlation with functional imaging indexes and tau levels in the cerebrospinal fluid. Discussion: This trial has been designed to determine whether functional imaging indexes and tau level in the cerebrospinal fluid can predict recovery of cognitive function in patients with traumatic brain injury. It will provide objective evidence for the clinical prevention and treatment of cognitive dysfunction following traumatic brain injury. Trial registration: This trial was registered at Chinese Clinical Trial Registry (registration number: ChiCTR-OOC-16008574) on 31 May 2016. Ethics: Approved by the Ethics Committee of the 101 st Hospital of PLA, China (approval number: L2016002), the study protocol will be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Written informed consent will be obtained from participants or their guardians.
{"title":"Cognitive function and biomarkers after traumatic brain injury: protocol for a prospective inception cohort study","authors":"Wei Lin, Likun Yang, Sang Cai, Jie Zhu, Yi Feng, Li-xiang Yang, Zhi-zhong Feng, Peipei Li, Junhui Chen, Yuhai Wang","doi":"10.4103/2468-5577.193144","DOIUrl":"https://doi.org/10.4103/2468-5577.193144","url":null,"abstract":"Background: Traumatic brain injury is a high-incidence condition that can cause severe cognitive impairment. At present, functional magnetic resonance imaging is used to analyze changes in brain function and network connectivity at different stages of injury. In addition, tau protein expression in nerve cells may reflect cognitive function. However, the combined use of functional magnetic resonance imaging and tau measurement to assess cognitive function following traumatic brain injury has not yet been investigated. Methods/Design: A prospective inception cohort study will be performed at the 101 st Hospital of PLA, Wuxi, China. We will conduct a follow-up visit in 100 patients with traumatic brain injury. Cognitive function will be assessed within 24 hours of injury and 0.5, 1, and 2 years after injury. Primary outcomes will be the Montreal Cognitive Assessment score, functional magnetic resonance imaging results, and tau protein level in the cerebrospinal fluid. Secondary outcomes will include Mini-Mental State Examination Scale and Hamilton Depression Scale scores. We will assess cognitive function in patients with traumatic brain injury and analyze its correlation with functional imaging indexes and tau levels in the cerebrospinal fluid. Discussion: This trial has been designed to determine whether functional imaging indexes and tau level in the cerebrospinal fluid can predict recovery of cognitive function in patients with traumatic brain injury. It will provide objective evidence for the clinical prevention and treatment of cognitive dysfunction following traumatic brain injury. Trial registration: This trial was registered at Chinese Clinical Trial Registry (registration number: ChiCTR-OOC-16008574) on 31 May 2016. Ethics: Approved by the Ethics Committee of the 101 st Hospital of PLA, China (approval number: L2016002), the study protocol will be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Written informed consent will be obtained from participants or their guardians.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79043660","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}
Pub Date : 2016-10-01DOI: 10.4103/2468-5577.193149
P. Pin-on
The main purposes of the review in the scalp blockade topic are to explore the background and the importance of post-craniotomy pain, briefly review scalp innervation, and give some examples of the controversial results of many previous studies. I also included my previous study of pre-incisional scalp blockade which added some inconclusive results to this arena.
{"title":"Regional anesthesia to scalp for craniotomy surgery","authors":"P. Pin-on","doi":"10.4103/2468-5577.193149","DOIUrl":"https://doi.org/10.4103/2468-5577.193149","url":null,"abstract":"The main purposes of the review in the scalp blockade topic are to explore the background and the importance of post-craniotomy pain, briefly review scalp innervation, and give some examples of the controversial results of many previous studies. I also included my previous study of pre-incisional scalp blockade which added some inconclusive results to this arena.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75784037","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}
Pub Date : 2016-07-01DOI: 10.4103/2468-5577.187078
Chao-liang Tang, Juan Li, Bo Zhao, J. Hou, Z. Xia
Background: Conventional mechanical ventilation often leads to lung inflammatory responses and oxidative stress, influencing a patient′s prognosis. Lung protective ventilation has been widely used during one-lung ventilation and abdominal surgeries as it can reduce lung tissue injury and improve systemic oxygenation. However, there are few reports on its use during craniotomy. Methods/Design: This multi-center, randomized, parallel, controlled trial will be performed at Anhui Provincial Hospital (Southern District), and the Renmin Hospital of Wuhan University, China. Sixty patients scheduled to undergo craniotomy and meeting our eligibility criteria will be randomly allocated to undergo either lung protective ventilation (6 mL/kg tidal volume, 10 cmH 2 O positive end-expiratory pressure, respiratory frequency 15 breaths/min; n = 30) or conventional mechanical ventilation (10 mL/kg tidal volume, respiratory frequency 12 breaths/min; n = 30). All patients will be evaluated from just prior to surgery (at changing of the ventilation mode) to immediately after extubation. The primary outcome measure will be dynamic lung compliance. The secondary outcome measures will be respiratory index, mean airway pressure, plateau pressure, alveolar and plasma markers of inflammation, and oxidative stress. Discussion: The outcomes will reveal the effects of a protective ventilation strategy using low tidal volumes and the use of positive end-expiratory pressure on respiratory status, postoperative pulmonary and systemic inflammation, and oxidative stress in patients undergoing craniotomy. This will provide objective evidence for the safety of protective ventilation during craniotomy. Trial registration: This trial was registered at Chinese Clinical Trial Registry (registration number: ChiCTR-IPR-16008029) on 1 March 2016. Ethics: The study protocol was approved by the Ethics Committee of Anhui Provincial Hospital, China (approval number: 2014-59) on 27 November 2014 and will be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Written informed consent will be obtained from participants or their guardians.
{"title":"Effects of lung protective ventilation on pulmonary function, inflammation, and oxidative stress in patients undergoing craniotomy: study protocol for a multi-center, randomized, parallel, controlled trial","authors":"Chao-liang Tang, Juan Li, Bo Zhao, J. Hou, Z. Xia","doi":"10.4103/2468-5577.187078","DOIUrl":"https://doi.org/10.4103/2468-5577.187078","url":null,"abstract":"Background: Conventional mechanical ventilation often leads to lung inflammatory responses and oxidative stress, influencing a patient′s prognosis. Lung protective ventilation has been widely used during one-lung ventilation and abdominal surgeries as it can reduce lung tissue injury and improve systemic oxygenation. However, there are few reports on its use during craniotomy. Methods/Design: This multi-center, randomized, parallel, controlled trial will be performed at Anhui Provincial Hospital (Southern District), and the Renmin Hospital of Wuhan University, China. Sixty patients scheduled to undergo craniotomy and meeting our eligibility criteria will be randomly allocated to undergo either lung protective ventilation (6 mL/kg tidal volume, 10 cmH 2 O positive end-expiratory pressure, respiratory frequency 15 breaths/min; n = 30) or conventional mechanical ventilation (10 mL/kg tidal volume, respiratory frequency 12 breaths/min; n = 30). All patients will be evaluated from just prior to surgery (at changing of the ventilation mode) to immediately after extubation. The primary outcome measure will be dynamic lung compliance. The secondary outcome measures will be respiratory index, mean airway pressure, plateau pressure, alveolar and plasma markers of inflammation, and oxidative stress. Discussion: The outcomes will reveal the effects of a protective ventilation strategy using low tidal volumes and the use of positive end-expiratory pressure on respiratory status, postoperative pulmonary and systemic inflammation, and oxidative stress in patients undergoing craniotomy. This will provide objective evidence for the safety of protective ventilation during craniotomy. Trial registration: This trial was registered at Chinese Clinical Trial Registry (registration number: ChiCTR-IPR-16008029) on 1 March 2016. Ethics: The study protocol was approved by the Ethics Committee of Anhui Provincial Hospital, China (approval number: 2014-59) on 27 November 2014 and will be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Written informed consent will be obtained from participants or their guardians.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73444914","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}
Pub Date : 2016-07-01DOI: 10.4103/2468-5577.187082
P. Guertin
The pharmaceutical industry has been facing tremendous challenges in recent years. Its Research & Development activities for innovation and drug development have significantly slowed down. Researchers in academic institutions often collaborate with pharmaceutical companies by providing them with new innovative products. However, the type of funding that they normally have access to does not ease drug development beyond discovery level. Here is a list of seven alternative opportunities that may help scientists, in North America, Europe and Asia, developing further their products and overcoming the so-called "Valley of Death". This may contribute bridging the gap between them and what Big Pharma is looking for, especially for the development of central nervous system products.
{"title":"Seven alternative opportunities to overcome the \"Valley of Death\" for CNS drug candidates developed by academic researchers","authors":"P. Guertin","doi":"10.4103/2468-5577.187082","DOIUrl":"https://doi.org/10.4103/2468-5577.187082","url":null,"abstract":"The pharmaceutical industry has been facing tremendous challenges in recent years. Its Research & Development activities for innovation and drug development have significantly slowed down. Researchers in academic institutions often collaborate with pharmaceutical companies by providing them with new innovative products. However, the type of funding that they normally have access to does not ease drug development beyond discovery level. Here is a list of seven alternative opportunities that may help scientists, in North America, Europe and Asia, developing further their products and overcoming the so-called \"Valley of Death\". This may contribute bridging the gap between them and what Big Pharma is looking for, especially for the development of central nervous system products.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90136174","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}
Background: Short-duration cognitive behavioral therapy is an effective method for the treatment of obsessive-compulsive disorder. It alters the functions of multiple brain regions or tissues, and improves symptoms. Imaging studies show changes in the microstructure of white matter fiber bundles of patients with obsessive-compulsive disorder. Methods/Design: We will conduct a single-blind, parallel, controlled trial in the Beijing Anding Hospital, Capital Medical University, China. A cohort of 60 patients with obsessive-compulsive disorder will undergo 12 weeks of cognitive behavioral therapy. An additional 60 healthy controls will comprise the control group. All participants will be evaluated before and after 12 weeks of treatment. The primary outcome will be fractional anisotropy values in the frontal-striatal-thalamic circuits assessed by diffusion tensor imaging. The secondary outcomes will be Yale-Brown Obsessive-Compulsive Scale, Hamilton Depression Rating Scale, and Hamilton Anxiety Scale scores. Discussion: This trial will assess the changes in white matter fibers of patients with obsessive-compulsive disorder after treatment with cognitive behavioral therapy using diffusion tensor imaging. This will hopefully reveal the neural mechanisms underlying the treatment of obsessive-compulsive disorder by cognitive behavioral therapy. It will also provide objective clinical evidence of its effectiveness, and for the development of individual treatment strategies. Trial registration: This trial was registered with the Chinese Clinical Trial Registry (http://www.chictr.org.cn/) (ChiCTR-IOR-14005436) on 29 October 2014. Ethics: The study protocol was approved by the Ethics Committee of Beijing Anding Hospital of Capital Medical University of China on 17 June 2013, approval number (2013)Keyan(7). Informed consent: Written informed consent will be provided by participants and their guardians.
{"title":"Effects of cognitive behavioral therapy on white matter fibers of patients with obsessive-compulsive disorder as assessed by diffusion tensor imaging: study protocol for a parallel group, controlled trial","authors":"Xiang-yun Yang, Jia Luo, Jing Liu, Yun Ma, Zhi-hua Guo, Xiao-jie Yang, Zhanjiang Li","doi":"10.4103/2468-5577.187077","DOIUrl":"https://doi.org/10.4103/2468-5577.187077","url":null,"abstract":"Background: Short-duration cognitive behavioral therapy is an effective method for the treatment of obsessive-compulsive disorder. It alters the functions of multiple brain regions or tissues, and improves symptoms. Imaging studies show changes in the microstructure of white matter fiber bundles of patients with obsessive-compulsive disorder. Methods/Design: We will conduct a single-blind, parallel, controlled trial in the Beijing Anding Hospital, Capital Medical University, China. A cohort of 60 patients with obsessive-compulsive disorder will undergo 12 weeks of cognitive behavioral therapy. An additional 60 healthy controls will comprise the control group. All participants will be evaluated before and after 12 weeks of treatment. The primary outcome will be fractional anisotropy values in the frontal-striatal-thalamic circuits assessed by diffusion tensor imaging. The secondary outcomes will be Yale-Brown Obsessive-Compulsive Scale, Hamilton Depression Rating Scale, and Hamilton Anxiety Scale scores. Discussion: This trial will assess the changes in white matter fibers of patients with obsessive-compulsive disorder after treatment with cognitive behavioral therapy using diffusion tensor imaging. This will hopefully reveal the neural mechanisms underlying the treatment of obsessive-compulsive disorder by cognitive behavioral therapy. It will also provide objective clinical evidence of its effectiveness, and for the development of individual treatment strategies. Trial registration: This trial was registered with the Chinese Clinical Trial Registry (http://www.chictr.org.cn/) (ChiCTR-IOR-14005436) on 29 October 2014. Ethics: The study protocol was approved by the Ethics Committee of Beijing Anding Hospital of Capital Medical University of China on 17 June 2013, approval number (2013)Keyan(7). Informed consent: Written informed consent will be provided by participants and their guardians.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90752822","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}
Pub Date : 2016-07-01DOI: 10.4103/2468-5577.187083
A. Trevizol, Q. Cordeiro
{"title":"Commentary on \"Effects of ultra-low frequency transcranial magnetic stimulation on motor function and intelligence of children with spastic cerebral palsy: study protocol for a randomized parallel-cohort controlled trial\"","authors":"A. Trevizol, Q. Cordeiro","doi":"10.4103/2468-5577.187083","DOIUrl":"https://doi.org/10.4103/2468-5577.187083","url":null,"abstract":"","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87501236","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}
Pub Date : 2016-07-01DOI: 10.4103/2468-5577.187080
M. Cervantes, C. Murata, Volkmar Wanzke del Angel
Background: Studies have demonstrated the efficacy of laughter in contributing to a better quality of life. Strategies can be optimized to elevate tolerance to pain and to combat stress, thereby reducing the impacts of stress, such as the increase in arterial tension, reduction in perfusion of the non-motor organs, an increase in cellular metabolism, and a greater risk of infections. Despite the increased interest in this topic, there is still a need for more research, because many of such studies are limited by diverse methodological problems, such as lack of objective evaluations, clear distinction between laughter and humor, and establishment of dosage of the therapies (frequency and time). The objective of the current study is to determine the efficacy of spontaneous laughter in improving the post-operative prognosis for pediatric patients after minor surgery. Post-operative pain will be evaluated by the Visual Analog Scale, and urinary cortisol levels, duration of hospital stay, and anxiety by the State-Trait Anxiety Inventory for Children. Methods/Design: The study will be an open, randomized controlled trial, having three parallel arms: conventional post-operative management with analgesics; a second control group consisting of conventional treatment with an accompaniment that does not induce laughter; and an experimental group based on conventional treatment plus laughter therapy. Pediatric patients (6-14 years of age; n = 70 per group), hospitalized for minor surgery in a Mexico City hospital, will be randomly assigned to one of the three groups. Generalized linear models will be constructed to determine the adjusted effects of laughter therapy on the intensity of pain, anxiety, and duration of hospital stay. Discussion: To the best of our knowledge, no clinical trial to determine the effect of laughter therapy exists in which the effect of the vehicle is controlled. Here, we controlled this potential confounding factor by establishing a control group "accompaniment without laughter". As a secondary outcome variable, measurement of urinary cortisol levels will provide objective evidence to complement the subjective measurement of the pain as perceived by the patient. As a co-variable, the duration of effective laughter will provide greater robustness to this study. Trial registration: This trial was registered at ClinicalTrials.gov (identifier: NCT02563587) on 28 September 2015. Informed consent: The research protocol of this study has been approved by the Ethics Committee of the Hospital General Naval de Alta Especialidad de la Secretaría de Marina de la Armada de México (approval number: 076). This research adheres to the guidelines set forth in the NORMA Oficial Mexicana NOM-012-SSA3-2012 and in the Declaration of Helsinki.
背景:研究已经证明了笑在提高生活质量方面的功效。可以优化策略以提高对疼痛的耐受性和对抗压力，从而减少压力的影响，例如动脉张力增加，非运动器官灌注减少，细胞代谢增加，感染风险增加。尽管对这个话题的兴趣越来越大，但仍然需要更多的研究，因为许多这样的研究受到各种方法问题的限制，例如缺乏客观的评估，笑声和幽默的明确区分，以及治疗剂量的确定(频率和时间)。本研究的目的是确定自发性笑在改善小儿小手术患者术后预后方面的效果。术后疼痛将通过视觉模拟量表、尿皮质醇水平、住院时间和儿童状态-特质焦虑量表评估。方法/设计:该研究将是一项开放、随机对照试验，有三个平行组:常规术后镇痛治疗;第二个控制组由传统治疗和不引起笑声的伴奏组成;另一组是基于传统疗法加笑声疗法的实验组。儿童患者(6-14岁;在墨西哥城医院接受小手术的患者(每组70人)将被随机分配到三组中的一组。我们将建立广义线性模型，以确定笑声治疗对疼痛强度、焦虑程度和住院时间的调整效应。讨论:据我们所知，没有临床试验来确定笑疗法的效果，其中车辆的效果是可控的。在这里，我们通过建立一个“没有笑声的陪伴”的对照组来控制这个潜在的混淆因素。作为次要结果变量，尿皮质醇水平的测量将提供客观证据，以补充患者感知的疼痛的主观测量。作为协变量，有效笑声的持续时间将为本研究提供更大的稳健性。试验注册:该试验于2015年9月28日在ClinicalTrials.gov注册(标识符:NCT02563587)。知情同意:本研究的研究方案已获得萨尔瓦多阿尔塔特别海军医院伦理委员会(Secretaría de Marina de la Armada de m xico)的批准(批准号:076)。本研究遵循NORMA official Mexicana NOM-012-SSA3-2012和赫尔辛基宣言中规定的指导方针。
{"title":"Efficacy of spontaneous laughter in the post-operative treatment of pain and anxiety in children: study protocol for a randomized controlled trial","authors":"M. Cervantes, C. Murata, Volkmar Wanzke del Angel","doi":"10.4103/2468-5577.187080","DOIUrl":"https://doi.org/10.4103/2468-5577.187080","url":null,"abstract":"Background: Studies have demonstrated the efficacy of laughter in contributing to a better quality of life. Strategies can be optimized to elevate tolerance to pain and to combat stress, thereby reducing the impacts of stress, such as the increase in arterial tension, reduction in perfusion of the non-motor organs, an increase in cellular metabolism, and a greater risk of infections. Despite the increased interest in this topic, there is still a need for more research, because many of such studies are limited by diverse methodological problems, such as lack of objective evaluations, clear distinction between laughter and humor, and establishment of dosage of the therapies (frequency and time). The objective of the current study is to determine the efficacy of spontaneous laughter in improving the post-operative prognosis for pediatric patients after minor surgery. Post-operative pain will be evaluated by the Visual Analog Scale, and urinary cortisol levels, duration of hospital stay, and anxiety by the State-Trait Anxiety Inventory for Children. Methods/Design: The study will be an open, randomized controlled trial, having three parallel arms: conventional post-operative management with analgesics; a second control group consisting of conventional treatment with an accompaniment that does not induce laughter; and an experimental group based on conventional treatment plus laughter therapy. Pediatric patients (6-14 years of age; n = 70 per group), hospitalized for minor surgery in a Mexico City hospital, will be randomly assigned to one of the three groups. Generalized linear models will be constructed to determine the adjusted effects of laughter therapy on the intensity of pain, anxiety, and duration of hospital stay. Discussion: To the best of our knowledge, no clinical trial to determine the effect of laughter therapy exists in which the effect of the vehicle is controlled. Here, we controlled this potential confounding factor by establishing a control group \"accompaniment without laughter\". As a secondary outcome variable, measurement of urinary cortisol levels will provide objective evidence to complement the subjective measurement of the pain as perceived by the patient. As a co-variable, the duration of effective laughter will provide greater robustness to this study. Trial registration: This trial was registered at ClinicalTrials.gov (identifier: NCT02563587) on 28 September 2015. Informed consent: The research protocol of this study has been approved by the Ethics Committee of the Hospital General Naval de Alta Especialidad de la Secretaría de Marina de la Armada de México (approval number: 076). This research adheres to the guidelines set forth in the NORMA Oficial Mexicana NOM-012-SSA3-2012 and in the Declaration of Helsinki.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76931978","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}
Pub Date : 2016-07-01DOI: 10.4103/2468-5577.187076
Juan Yang, Shu Ou, Jie Zhang, W. Dong, Jian Wang, Jin-he Lou
Background: Migraine is a global disease with a high morbidity rate, and while there is medication for migraine prevention, it has many side effects. Thus there is a need to find a non-drug therapy to prevent migraine in patients with frequent attacks of migraine, severe pain, and poor drug control. Cortical spreading depression (CSD) is an important pathological mechanism behind migraine. Electrical fastigial nucleus stimulation (FNS) can reportedly inhibit the occurrence and propagation of CSD, and therefore can be used to prevent migraine. Methods/Design: This is a prospective, multi-center, randomized, double-blind, sham-controlled trial. It will be performed at Chengdu Second People′s Hospital, the Second Affiliated Hospital of Chongqing Medical University, Chongqing Fourth People′s Hospital, the First Affiliated Hospital of Chongqing Medical University, and Chongqing People′s Hospital, China. The approach is to randomly allocate 80 eligible migraine patients to undergo 3 months of either noninvasive electrical FNS (pulse width 90 μs, frequency 1.8 kHz, and output current 10 mA) or ineffective sham-stimulation (using the same stimulation equipment; pulse width 90 μs, frequency 10 kHz, and output current 0.18 mA). The primary outcomes are: change in monthly migraine days between the run-in month and 3 rd month of treatment, and percentage of patients having at least a 50% reduction of monthly migraine days in the 3 rd month of treatment. The secondary outcomes are: change between average monthly migraine days across 3 months of treatment and monthly migraine days in the 3 rd month of treatment, Visual Analogue Scale score in the 3 rd month of treatment, change in monthly anti-migraine drug use between the run-in month and 3 rd month of treatment, migraine disability assessment questionnaire score, accompanying symptoms, and adverse reactions. Discussion: In previous studies on electrical FNS for the treatment of various brain injuries, sample sizes have been small with inclusion of only a small number of institutions and non-rigorous trial protocols. Accordingly, the data obtained were not very reliable. In this study, we will validate the efficacy of electrical FNS in migraine prevention using a multi-center, randomized, double-blinded, controlled trial. Our findings will provide evidence for clinical application of this method. Trial registration: The trial protocol was registered at Chinese Clinical Trial Registry (www.chictr.org.cn) (registration number: ChiCTR-ICR-15006273) on 5 April 2015. Ethics: This trial was approved by the Ethics Committee of Chengdu Second People′s Hospital, China on 9 April 2015 (approval number: 2015010), and will be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Written informed consent will be obtained from participants or their guardians.
{"title":"Migraine prevention by noninvasive electrical fastigial nucleus stimulation: a multi-center, randomized, double-blind, sham-controlled trial","authors":"Juan Yang, Shu Ou, Jie Zhang, W. Dong, Jian Wang, Jin-he Lou","doi":"10.4103/2468-5577.187076","DOIUrl":"https://doi.org/10.4103/2468-5577.187076","url":null,"abstract":"Background: Migraine is a global disease with a high morbidity rate, and while there is medication for migraine prevention, it has many side effects. Thus there is a need to find a non-drug therapy to prevent migraine in patients with frequent attacks of migraine, severe pain, and poor drug control. Cortical spreading depression (CSD) is an important pathological mechanism behind migraine. Electrical fastigial nucleus stimulation (FNS) can reportedly inhibit the occurrence and propagation of CSD, and therefore can be used to prevent migraine. Methods/Design: This is a prospective, multi-center, randomized, double-blind, sham-controlled trial. It will be performed at Chengdu Second People′s Hospital, the Second Affiliated Hospital of Chongqing Medical University, Chongqing Fourth People′s Hospital, the First Affiliated Hospital of Chongqing Medical University, and Chongqing People′s Hospital, China. The approach is to randomly allocate 80 eligible migraine patients to undergo 3 months of either noninvasive electrical FNS (pulse width 90 μs, frequency 1.8 kHz, and output current 10 mA) or ineffective sham-stimulation (using the same stimulation equipment; pulse width 90 μs, frequency 10 kHz, and output current 0.18 mA). The primary outcomes are: change in monthly migraine days between the run-in month and 3 rd month of treatment, and percentage of patients having at least a 50% reduction of monthly migraine days in the 3 rd month of treatment. The secondary outcomes are: change between average monthly migraine days across 3 months of treatment and monthly migraine days in the 3 rd month of treatment, Visual Analogue Scale score in the 3 rd month of treatment, change in monthly anti-migraine drug use between the run-in month and 3 rd month of treatment, migraine disability assessment questionnaire score, accompanying symptoms, and adverse reactions. Discussion: In previous studies on electrical FNS for the treatment of various brain injuries, sample sizes have been small with inclusion of only a small number of institutions and non-rigorous trial protocols. Accordingly, the data obtained were not very reliable. In this study, we will validate the efficacy of electrical FNS in migraine prevention using a multi-center, randomized, double-blinded, controlled trial. Our findings will provide evidence for clinical application of this method. Trial registration: The trial protocol was registered at Chinese Clinical Trial Registry (www.chictr.org.cn) (registration number: ChiCTR-ICR-15006273) on 5 April 2015. Ethics: This trial was approved by the Ethics Committee of Chengdu Second People′s Hospital, China on 9 April 2015 (approval number: 2015010), and will be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Written informed consent will be obtained from participants or their guardians.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83297245","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}
Pub Date : 2016-07-01DOI: 10.4103/2468-5577.187079
P. Pin-on, Yodying Punjasawaswong
Background: Scalp block is a selective nerve block technique to inhibit the afferent input from nerves that innervate the scalp, including supratrochlear, supraorbital, zygomaticofacial, and zygomaticotemporal nerves for the anterior scalp. The greater and lesser occipital nerves innervate the posterior scalp. Methods/Design: This study is a prospective, randomized, double-blind, placebo-controlled trial, which will be performed to examine the benefits of a pre-incisional anterior scalp block with 0.5% bupivacaine in adult patients who are scheduled for supratentorial craniotomy to remove tumor. Primary outcome will be the difference of intraoperative fentanyl consumption between patients who receive anterior scalp block with 0.5% bupivacaine and those who receive normal saline solution administration. Secondary outcomes will be the hemodynamic changes from preoperative baseline at a skull pin insertion and the time from the end of surgery to successful extubation. Discussion: Skull pin insertion is known as the strongest stimulus prior to craniotomy. The results from previous studies are inconclusive regarding the advantage of scalp block as a pre-emptive analgesic technique. This study will fill this knowledge gap, and examine whether this technique is worth performing as a standard technique. Trial registration: ClinicalTrials.gov identifier: NCT02057367; registered in February 2014. Ethics: This study protocol was approved by the Ethics Committee of Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University, Thailand (approval number: ANE-2556-01510) and will be performed in accordance with the Declaration of Helsinki. Informed consent: Written informed consent will be obtained from participants prior to inclusion in this study.
{"title":"Effect of pre-incisional anterior scalp block on intraoperative opioid consumption in adult patients undergoing elective craniotomy to remove tumor: study protocol for a randomized double-blind trial","authors":"P. Pin-on, Yodying Punjasawaswong","doi":"10.4103/2468-5577.187079","DOIUrl":"https://doi.org/10.4103/2468-5577.187079","url":null,"abstract":"Background: Scalp block is a selective nerve block technique to inhibit the afferent input from nerves that innervate the scalp, including supratrochlear, supraorbital, zygomaticofacial, and zygomaticotemporal nerves for the anterior scalp. The greater and lesser occipital nerves innervate the posterior scalp. Methods/Design: This study is a prospective, randomized, double-blind, placebo-controlled trial, which will be performed to examine the benefits of a pre-incisional anterior scalp block with 0.5% bupivacaine in adult patients who are scheduled for supratentorial craniotomy to remove tumor. Primary outcome will be the difference of intraoperative fentanyl consumption between patients who receive anterior scalp block with 0.5% bupivacaine and those who receive normal saline solution administration. Secondary outcomes will be the hemodynamic changes from preoperative baseline at a skull pin insertion and the time from the end of surgery to successful extubation. Discussion: Skull pin insertion is known as the strongest stimulus prior to craniotomy. The results from previous studies are inconclusive regarding the advantage of scalp block as a pre-emptive analgesic technique. This study will fill this knowledge gap, and examine whether this technique is worth performing as a standard technique. Trial registration: ClinicalTrials.gov identifier: NCT02057367; registered in February 2014. Ethics: This study protocol was approved by the Ethics Committee of Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University, Thailand (approval number: ANE-2556-01510) and will be performed in accordance with the Declaration of Helsinki. Informed consent: Written informed consent will be obtained from participants prior to inclusion in this study.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78427778","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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