The International Institute for The Advanced Studies of Psychotherapy and Applied Mental Health, Babeș-Bolyai University, Cluj-Napoca, Romania.
Evidence-Based Psychological Assessment and Interventions Doctoral School, Babeș-Bolyai University, Cluj-Napoca, Romania.
Trials. 2021 Apr 19;22(1):289. doi: 10.1186/s13063-021-05196-7.
Pain after surgery is normal, and treatments, including both pharmacological and psychological components, are fundamental for proper postoperative care. While several trials have investigated the analgesic effect of traditional non-pharmacological treatments, such as cognitive behavior therapies, the newer ways of delivering psychological interventions for pain after surgery are scarcely investigated. The aim of this randomized controlled trial (RCT) is to determine if delivering the psychological content through virtual reality (VR) along with the standard pharmacological treatment return better pain relief outcomes than standard care in adult patients following surgery.
This is a protocol of a parallel RCT conducted in one community hospital. In order to test the efficacy of VR environments for reducing pain intensity, in the following day after surgery, adults (18 to 65 years) will be randomly assigned to either (1) standard treatment after surgery (control group) or (2) VR based intervention along with standard treatment. It is intended that a minimum of 30 patients be recruited in each group. For estimating the intensity of pain, both self-report and physiological measures will be used. Repeated measures of pain outcomes will be taken before and after the intervention. Moreover, for allowing an in-depth investigation of the effect of VR environments, the primary outcome will be complemented with measures of the adverse effects, level of immersion, and level of presence in the VR environment.
手术后疼痛是正常的，包括药物和心理治疗在内的治疗方法是术后护理的基础。虽然已经有多项试验研究了传统非药物治疗方法（如认知行为疗法）的镇痛效果，但对于手术后心理干预的新方法的研究却很少。本随机对照试验（RCT）的目的是确定在手术后的成年人中，通过虚拟现实（VR）传递心理内容，与标准药物治疗相结合，是否比标准护理能更好地缓解疼痛。
这是在一家社区医院进行的平行 RCT 的方案。为了测试 VR 环境在减轻疼痛强度方面的疗效，在手术后的第二天，成年人（18 至 65 岁）将被随机分配到（1）手术后的标准治疗（对照组）或（2）标准治疗加 VR 干预。预计每组将招募至少 30 名患者。为了评估疼痛的强度，将同时使用自我报告和生理测量方法。在干预前后将进行多次疼痛结果的重复测量。此外，为了深入研究 VR 环境的效果，将使用 VR 环境中的不良反应、沉浸水平和存在水平等指标来补充主要结果。
