Orgil Zandantsetseg, Karthic Anitra, Bell Nora F, Heisterberg Lisa M, Williams Sara E, Ding Lili, Kashikar-Zuck Susmita, King Christopher D, Olbrecht Vanessa A
Abigail Wexner Research Institute, Nationwide Children's Hospital, Columbus, OH, United States.
Department of Anesthesiology, The Ohio State University College of Medicine, Columbus, OH, United States.
JMIR Perioper Med. 2024 Sep 16;7:e48959. doi: 10.2196/48959.
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.
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.
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.
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%).
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.
ClinicalTrials NCT04943874; https://clinicaltrials.gov/ct2/show/NCT04943874.
基于生物反馈的虚拟现实（VR - BF）是一种新颖的非药物方法，用于教导患者如何控制呼吸，进而增加心率变异性（HRV）并可能减轻疼痛。与传统的生物反馈形式不同，VR - BF通过游戏化的虚拟现实环境提供，提高了生物反馈的可及性。这是第一项在儿科围手术期系统整合VR - BF应用的研究，最终目标是在确定其可行性和可接受性后，评估VR - BF减轻疼痛、焦虑和阿片类药物消耗的效果。
主要目的是制定一项在儿科围手术期使用VR - BF的临床试验方案，包括术前教育和培训，以及在接受手术的儿童中术后应用VR - BF。次要目的是评估患者和家长对VR - BF的体验。
采用目的抽样法招募了23名计划在全国儿童医院接受手术的患者（12 - 18岁）。训练后，参与者在手术前7天和住院期间每天独立完成一次10分钟的VR - BF疗程，共7天。出院后参与者可使用VR - BF长达2周。测量VR - BF使用情况和目标HRV参数达成情况的患者层面和疗程层面数据，以确定该人群手术前后疗程的最佳频率和时长。进行标准化问卷调查和半结构化访谈，以获取患者对VR - BF体验的定性信息。
患者层面数据表明，在目标HRV参数下完成1个疗程的最高几率出现在4个疗程之后（4个疗程与3个疗程相比，优势比[OR]为5.1，95%置信区间1.3 - 20.6；3个疗程与2个疗程相比，OR为16.6，95%置信区间1.2 - 217.0）。疗程层面数据显示，9至10分钟的疗程时长在目标HRV参数下完成1个疗程的几率最大（9分钟与8分钟相比，OR为1.3，95%置信区间1.1 - 1.7；8分钟与7分钟相比，OR为1.4，95%置信区间1.1 - 1.8；10分钟与9分钟相比，OR为1，95%置信区间0.9 - 1.2）。定性数据显示患者对VR - BF技术满意，尤其是在管理围手术期压力方面（17/20，85%）。很少有患者报告VR - BF对疼痛有益（8/20，40%）。
接受手术的儿童和青少年通过每天一次10分钟、共5天的VR - BF成功学会了行为策略。为了在后续临床试验中将VR - BF作为一种治疗干预措施进行整合，将指导患者在术后每天完成三个10分钟的疗程，共7天。
ClinicalTrials NCT04943874；https://clinicaltrials.gov/ct2/show/NCT04943874
