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虚拟现实应用于慢性疼痛患者的家庭访视康复:单臂前后比较研究方案

Virtual Reality-Applied Home-Visit Rehabilitation for Patients With Chronic Pain: Protocol for Single-Arm Pre-Post Comparison Study.

作者信息

Funao Hiroki, Momosaki Ryo, Tsujikawa Mayumi, Kawamoto Eiji, Esumi Ryo, Shimaoka Motomu

机构信息

Department of Molecular Pathobiology and Cell Adhesion Biology, Mie University Graduate School of Medicine, Tsu, Japan.

Department of Practical Nursing, Mie University Graduate School of Medicine, Tsu, Japan.

出版信息

JMIR Res Protoc. 2024 Dec 30;13:e58734. doi: 10.2196/58734.

Abstract

BACKGROUND

Pain inhibits rehabilitation. In rehabilitation at medical institutions, the usefulness of virtual reality (VR) has been reported in many cases to alleviate pain. In recent years, the demand for home rehabilitation has increased. Unlike in medical situations, the patients targeted for in-home rehabilitation often have chronic pain due to physical and psychosocial factors, and the environment is not specialized for rehabilitation. However, VR might be effective for in-home rehabilitation settings.

OBJECTIVE

This study aims to evaluate the feasibility of applying VR to home-visit rehabilitation for homebound patients with chronic pain.

METHODS

This study will test the feasibility of VR applied to home-visit rehabilitation for patients with chronic pain. A single-arm pre-post comparison will be conducted to evaluate its feasibility. Screening will be conducted on patients who have given consent to participate in the study, and those who have pain that persists or recurs for more than 3 months and receive home-visit rehabilitation will be enrolled in the study. Baseline measurements will be conducted on study participants before the start of the VR intervention. VR-applied home-visit rehabilitation will be conducted once a week for a total of 10 VR interventions. The primary endpoint is the change in pain from the baseline to the tenth intervention. Pain is a subjective symptom of the study participants and will be subjectively assessed by the Numerical Rating Scale of 11 levels from 0 to 10. Pain as the primary endpoint will be measured at 3-time points per rehabilitation session: before, during, and after the rehabilitation so that changes between time points can be evaluated. Secondary endpoints are heart rate variability, range of motion of the area in the musculoskeletal system where the pain occurs, motivation for rehabilitation, catastrophic thoughts of pain, mood state, quality of life, and interviews. Assessments will be conducted at the baseline, first, fifth, and tenth interventions. After completing the clinical study (10 VR interventions), patients will continue their regular home-visit rehabilitation as usual.

RESULTS

Recruitment of participants began on February 22, 2022, and data collection is ongoing as of November 2024. The research results will be published in international peer-reviewed journals and through presentations at national and international conferences.

CONCLUSIONS

This study will contribute to the development of novel rehabilitation-based solutions for homebound patients who have had difficulty obtaining adequate relief from chronic pain. Future studies will consider conducting randomized controlled trials as clinical trials to validate the efficacy of VR during home-visit rehabilitation for patients with chronic pain.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/58734.

摘要

背景

疼痛会阻碍康复。在医疗机构的康复过程中,已有许多案例报道虚拟现实(VR)有助于缓解疼痛。近年来,家庭康复的需求有所增加。与医疗环境不同,接受家庭康复治疗的患者通常因身体和心理社会因素而患有慢性疼痛,且家庭环境并非专门用于康复。然而,VR可能对家庭康复环境有效。

目的

本研究旨在评估将VR应用于居家慢性疼痛患者上门康复的可行性。

方法

本研究将测试VR应用于慢性疼痛患者上门康复的可行性。将进行单臂前后比较以评估其可行性。对同意参与研究的患者进行筛查,纳入那些疼痛持续或复发超过3个月且接受上门康复治疗的患者。在VR干预开始前对研究参与者进行基线测量。每周进行一次应用VR的上门康复治疗,共进行10次VR干预。主要终点是从基线到第十次干预时疼痛的变化。疼痛是研究参与者的主观症状,将通过0至10的11级数字评分量表进行主观评估。作为主要终点的疼痛将在每次康复治疗的3个时间点进行测量:康复前、康复期间和康复后,以便评估时间点之间的变化。次要终点包括心率变异性、疼痛发生部位的肌肉骨骼系统区域的活动范围、康复动机、对疼痛的灾难性想法、情绪状态、生活质量以及访谈。评估将在基线、第一次、第五次和第十次干预时进行。完成临床研究(10次VR干预)后,患者将继续照常进行定期上门康复治疗。

结果

参与者招募于2022年2月22日开始,截至2024年11月数据收集仍在进行中。研究结果将发表在国际同行评审期刊上,并在国内和国际会议上进行展示。

结论

本研究将有助于为难以从慢性疼痛中获得充分缓解的居家患者开发基于康复的新解决方案。未来的研究将考虑进行随机对照试验作为临床试验,以验证VR在慢性疼痛患者上门康复期间的疗效。

国际注册报告识别码(IRRID):DERR1-10.2196/58734。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/94b3/11730232/1097b836f767/resprot_v13i1e58734_fig1.jpg

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