The Effect of Cognitive Behavioral Therapy and Virtual Reality Use in Supporting Physical Rehabilitation After Anterior Cruciate Ligament (ACL) Operation: A Parallel-Arm Randomized Controlled Trial

Hacettepe University1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2023年4月5日最近更新: 2026年8月13日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Hacettepe University
入组人数: 60
试验地点: 1
主要终点: Return to Sport After Serious Injury Questionnaire (RSSIQ)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

In this study, which aimed to develop a Cognitive Behavioral Therapy (CBT) protocol enriched with Virtual Reality (VR) to address the psychological responses that arise after ACL surgery, and to examine the effectiveness of this protocol. The effectiveness of the protocol was assessed using pre-test, post-test, and two follow-up measurements with the Re-Injury Anxiety Inventory (RIAI), the Sport Injury Rehabilitation Adherence Scale (SIRAS), the Tampa Scale for Kinesiophobia (TSK), the Athletic Injury Self-Efficacy Questionnaire (AISEQ), the Return to Sport After Serious Injury Questionnaire (RSSIQ), and the Anterior Cruciate Ligament Return to Sport Scale (ACL-RSI). Anxiety levels during VR exposure sessions were measured through biofeedback and the Subjective Units of Distress Scale (SUDS).

详细描述

In this study, which aimed to develop a Cognitive Behavioral Therapy (CBT) protocol enriched with Virtual Reality (VR) to address the psychological responses that arise after ACL surgery, and to examine the effectiveness of this protocol. The protocol was developed in 5 stages and a randomized controlled trial was conducted with 60 athletes to test its effectiveness. The study consisted of 3 experimental and 2 control groups. One of the control group was a plasebo control group.The effectiveness of the protocol was assessed using pre-test, post-test, and follow-up measurements with the Re-Injury Anxiety Inventory (RIAI), the Sport Injury Rehabilitation Adherence Scale (SIRAS), the Tampa Scale for Kinesiophobia (TSK), the Athletic Injury Self-Efficacy Questionnaire (AISEQ), the Return to Sport After Serious Injury Questionnaire (RSSIQ), and the Anterior Cruciate Ligament Return to Sport Scale (ACL-RSI). Anxiety levels during VR exposure sessions were measured through biofeedback and the Subjective Units of Distress Scale (SUDS).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Supportive Care
盲法: None

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•Volunteering to participate in the study
•Have had an ACL injury operation
•Be between the ages of 18 and 45
•To be a professional athlete in Turkish leagues
•Being an athlete in football, volleyball, and basketball

排除标准

•Having a discomfort that prevents participants from participating in VR sessions (panic attack, epilepsy, etc.)
•Having decided to quit sports even if participants will continue rehabilitation after the operation

研究组 & 干预措施

Control Group

No Intervention

This arm have no intervention during the research. They only had been followed up by researchers

Control

Placebo Comparator

干预措施: Control (placebo) group (Behavioral)

CBT (Cognitive Behavioral Therapy)

Experimental

干预措施: CBT (Cognitive Behavioral Therapy) (Other)

VR (Virtual reality)

Experimental

干预措施: VR (Virtual reality) (Behavioral)

CBT+VR (Cognitive behavioral therapy and virtual reality)

Experimental

干预措施: CBT+VR (Cognitive behavioral therapy and virtual reality) (Other)