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单次“增强缓解”视频会议式团体干预对慢性疼痛的比较疗效:一项随机对照试验的研究方案

Comparative efficacy of a single-session "Empowered Relief" videoconference-delivered group intervention for chronic pain: study protocol for a randomized controlled trial.

作者信息

Ziadni Maisa S, Anderson Steven R, Gonzalez-Castro Lluvia, Darnall Beth D

机构信息

Department of Anesthesiology, Perioperative and Pain Medicine, Division of Pain Medicine, Stanford University School of Medicine, 1070 Arastradero Road, Suite 200, Palo Alto, CA, 94304, USA.

出版信息

Trials. 2021 May 22;22(1):358. doi: 10.1186/s13063-021-05303-8.

Abstract

BACKGROUND

Chronic pain is naturally aversive and often distressing for patients. Pain coping and self-regulatory skills have been shown to effectively reduce pain-related distress and other symptoms. In this trial, the primary goal is to pilot test the comparative efficacy of a single-session videoconference-delivered group pain education class to a waitlist control among patients with chronic pain.

METHODS

Our study is a randomized clinical trial pilot testing the superiority of our 2-h single-session videoconference-delivered group pain education class against a waitlist control. We will enroll 120 adult patients with mixed etiology chronic pain and randomize 1:1 to one of the two study arms. We hypothesize superiority for the pain education class for bolstering pain and symptom management. Team researchers masked to treatment assignment will assess the outcomes up to 3 months post-treatment.

DISCUSSION

This study aims to test the utility of a single-session videoconference-delivered group pain education class to improve self-regulation of pain and pain-related outcomes. Findings from our project have the potential to significantly reduce barriers to effective psychological treatment for pain, optimizing the delivery of increasingly vital online and remote-delivered intervention options.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04546685 . Registered on 04 September 2020.

摘要

背景

慢性疼痛对患者来说自然是令人厌恶的,而且常常令人痛苦。疼痛应对和自我调节技能已被证明能有效减轻与疼痛相关的痛苦和其他症状。在本试验中,主要目标是对通过视频会议进行的单次团体疼痛教育课程与慢性疼痛患者的等待名单对照组的比较疗效进行试点测试。

方法

我们的研究是一项随机临床试验,试点测试我们通过视频会议进行的2小时单次团体疼痛教育课程相对于等待名单对照组的优越性。我们将招募120名病因混合的慢性疼痛成年患者,并以1:1的比例随机分配到两个研究组之一。我们假设疼痛教育课程在加强疼痛和症状管理方面具有优越性。对治疗分配不知情的团队研究人员将在治疗后长达3个月的时间内评估结果。

讨论

本研究旨在测试通过视频会议进行的单次团体疼痛教育课程在改善疼痛自我调节和与疼痛相关的结果方面的效用。我们项目的研究结果有可能显著减少有效疼痛心理治疗的障碍,优化越来越重要的在线和远程干预选项的提供。

试验注册

ClinicalTrials.gov NCT04546685。于2020年9月4日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9b37/8140415/c55472fbafc4/13063_2021_5303_Fig1_HTML.jpg

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