Ferreira-Valente Alexandra, Pimenta Filipa, Costa Rui M, Day Melissa A, Pais-Ribeiro José, Jensen Mark P
William James Center for Research, ISPA - University Institute, Lisbon, Portugal
Department of Rehabilitation Medicine, University of Washington, Seattle, Washington, USA.
BMJ Open. 2021 Feb 8;11(2):e040068. doi: 10.1136/bmjopen-2020-040068.
There has been an increasing interest in studying the potential benefits of so-called complementary and alternative approaches for pain management, such as hypnosis and mindfulness-based interventions. More recently, researchers have been interested in studying the effects of spiritual practices on pain experience as well. These practices may increase pain tolerance, result in a positive re-appraisal of pain and influence other psychological variables that are known to be associated with pain experience. The purpose of this study is to evaluate and compare the immediate effects of self-hypnosis, mindfulness meditation, and a spiritual intervention relative to a control condition for increasing pain tolerance and reducing pain intensity and pain-related stress, in response to experimental painful stimulation.
Recruitment is anticipated to start in November 2020. This is a randomised quantitative experimental mixed-design repeated-measures study with three assessment points: baseline (T0), pre-test (T1) and post-test (T2). Eligible healthy adults will be randomised to one of the four study conditions. Interventions will be a 20-minute audio-guided practice of either self-hypnosis, mindfulness meditation, or Christian prayer. Participants in the control group will not be instructed to use any specific strategy during the painful stimulation. Participants will be submitted to a first cycle of Cold Pressor Arm Wrap. They will then listen to a 20-minute audio recording inducing one of the three interventions, or, in the case of the control group, to a 20-minute audio recording of text from a natural history textbook. Primary outcomes are pain intensity and pain tolerance. Pain-related stress as measured by salivary cortisol level and heart rate variability are secondary outcomes.
This study was approved by ISPA-University Institute's internal Ethics Committee for Research on 3rd December 2018 (reference I/010/12/2018). Findings will be published in peer-reviewed indexed journals and presented at conferences.
ClinicalTrials.gov registry (NCT04491630). Stage: pre-results.
人们对研究所谓的补充和替代方法在疼痛管理中的潜在益处越来越感兴趣，比如催眠和基于正念的干预措施。最近，研究人员也开始关注精神修行对疼痛体验的影响。这些修行可能会提高疼痛耐受性，对疼痛产生积极的重新评估，并影响其他已知与疼痛体验相关的心理变量。本研究的目的是评估和比较自我催眠、正念冥想和一种精神干预相对于对照条件对提高疼痛耐受性、降低疼痛强度和与疼痛相关的压力的即时效果，以应对实验性疼痛刺激。
预计于2020年11月开始招募。这是一项随机定量实验混合设计重复测量研究，有三个评估点：基线（T0）、预测试（T1）和后测试（T2）。符合条件的健康成年人将被随机分配到四种研究条件之一。干预措施将是一段20分钟的音频引导练习，内容为自我催眠、正念冥想或基督教祈祷。对照组的参与者在疼痛刺激期间不会被指导使用任何特定策略。参与者将接受第一轮冷压臂包裹测试。然后，他们将收听一段20分钟的音频记录，该记录会引导进行三种干预措施之一，或者在对照组的情况下，收听一段来自自然历史教科书文本的20分钟音频记录。主要结果是疼痛强度和疼痛耐受性。通过唾液皮质醇水平和心率变异性测量的与疼痛相关的压力是次要结果。
本研究于2018年12月3日获得ISPA大学研究所内部研究伦理委员会批准（参考编号I/010/12/2018）。研究结果将发表在同行评审的索引期刊上，并在会议上展示。
ClinicalTrials.gov注册库（NCT04491630）。阶段：结果前。
