在接受手术的儿童和青少年中使用基于生物反馈的虚拟现实系统的可行性和可接受性:试点观察研究的第一阶段。

Zandantsetseg Orgil, Anitra Karthic, Nora F Bell, Lisa M Heisterberg, Sara E Williams, Lili Ding, Susmita Kashikar-Zuck, Christopher D King, Vanessa A Olbrecht
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引用次数: 0

摘要

背景:基于生物反馈的虚拟现实(VR-BF)是一种新颖的非药物疗法,用于指导患者如何控制呼吸,进而提高心率变异性(HRV)并减轻疼痛。与传统形式的生物反馈(BF)不同,VR-BF 是通过游戏化的虚拟现实环境提供的,从而提高了生物反馈的可及性。这是第一项在儿科围手术期环境中系统整合使用 VR-BF 的研究,其最终目标是在确定可行性和可接受性后,评估 VR-BF 在减轻疼痛、焦虑和阿片类药物消耗方面的疗效:首要目标是制定在儿科围手术期使用 VR-BF 的临床试验方案,包括对接受手术的儿童进行术前教育/培训和术后使用 VR-BF。次要目标是评估患者/家长使用 VR-BF 的体验:通过有目的的抽样,共招募了 23 名计划在全美儿童医院接受手术的患者(12-18 岁)。经过培训后,参与者在手术前七天和住院期间每天独立完成一次 10 分钟的 VR-BF 训练。参与者可在出院后两周内使用 VR-BF。对患者和疗程层面的 VR-BF 使用数据以及目标心率变异参数的实现情况进行了测量,以确定该人群手术前后的最佳疗程频率和持续时间。此外,还进行了标准化问卷调查和半结构化访谈,以获得有关患者使用 VR-BF 体验的定性信息:患者层面的数据显示,在目标心率变异参数下实现 1 会话的最高几率是在 4 次会话之后(OR 4 vs. 3 次会话=5.1,95% CI 1.3-20.6;OR 3 vs. 2 次会话=16.6,95% CI 1.2-217.0)。会话水平数据显示,会话持续时间为 9-10 分钟时,在目标心率变异参数下实现 1 会话的几率最大(OR 9 vs. 8 minutes=1.3,95% CI 1.1-1.7;OR 8 vs. 7 minutes=1.4,95% CI 1.1-1.8;OR 10 vs. 9 minutes=1.0,95% CI 0.9-1.2)。定性数据显示,患者对 VR-BF 技术表示满意,尤其是在控制围手术期压力方面(17 人,85%)。很少有患者表示 VR-BF 有助于缓解疼痛(8 人,占 40%):接受手术的儿童和青少年在为期 5 天、每天一次、每次 10 分钟的 VR-BF 治疗中成功学会了行为策略。为了将 VR-BF 作为治疗干预纳入后续临床试验,将指导患者在术后 7 天内每天完成三次 10 分钟的训练:临床试验:ClinicalTrials.gov; NCT04943874; https://clinicaltrials.gov/ct2/show/NCT04943874。
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Use of Biofeedback-Based Virtual Reality in Pediatric Perioperative and Postoperative Settings: Observational Study.

Background: Biofeedback-based virtual reality (VR-BF) is a novel, nonpharmacologic method for teaching patients how to control their breathing, which in turn increases heart rate variability (HRV) and may reduce pain. Unlike traditional forms of biofeedback, VR-BF is delivered through a gamified virtual reality environment, increasing the accessibility of biofeedback. This is the first study to systematically integrate VR-BF use in the pediatric perioperative setting, with the ultimate goal of evaluating the efficacy of VR-BF to reduce pain, anxiety, and opioid consumption once feasibility and acceptability have been established.

Objectives: The primary objective was to develop a clinical trial protocol for VR-BF use in the pediatric perioperative setting, including preoperative education and training, and postoperative application of VR-BF in children undergoing surgery. A secondary objective was to evaluate the patient and parent experience with VR-BF.

Methods: A total of 23 patients (12-18 years of age) scheduled for surgery at Nationwide Children's Hospital were recruited using purposive sampling. Following training, participants independently completed a daily, 10-minute VR-BF session for 7 days before surgery and during their inpatient stay. Participants could use VR-BF up to 2 weeks after hospital discharge. Patient- and session-level data of VR-BF usage and achievement of target HRV parameters were measured to identify the optimal frequency and duration of sessions before and after surgery for this population. Standardized questionnaires and semistructured interviews were conducted to obtain qualitative information about patients' experiences with VR-BF.

Results: Patient-level data indicated that the highest odds of achieving 1 session under target HRV parameters was after 4 sessions (odds ratio [OR] 5.1 for 4 vs 3 sessions, 95% CI 1.3-20.6; OR 16.6 for 3 vs 2 sessions, 95% CI 1.2-217.0). Session-level data showed that a session duration of 9 to 10 minutes provided the greatest odds of achieving 1 session under target HRV parameters (OR 1.3 for 9 vs 8 min, 95% CI 1.1-1.7; OR 1.4 for 8 vs 7 min, 95% CI 1.1-1.8; OR 1 for 10 vs 9 min, 95% CI 0.9-1.2). Qualitative data revealed patient satisfaction with the VR-BF technology, particularly in managing perioperative stress (17/20, 85%). Few patients reported VR-BF as beneficial for pain (8/20, 40%).

Conclusions: Children and adolescents undergoing surgery successfully learned behavioral strategies with VR-BF with 10-minute sessions once daily for 5 days. To integrate VR-BF as a therapeutic intervention in a subsequent clinical trial, patients will be instructed to complete three 10-minute sessions a day for 7 days after surgery.

Trial registration: ClinicalTrials NCT04943874; https://clinicaltrials.gov/ct2/show/NCT04943874.

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