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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hacettepe University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Return to Sport After Serious Injury Questionnaire (RSSIQ)
Study Overview
Brief Summary
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).
Detailed Description
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Control Group
This arm have no intervention during the research. They only had been followed up by researchers
Control
Intervention: Control (placebo) group (Behavioral)
CBT (Cognitive Behavioral Therapy)
Intervention: CBT (Cognitive Behavioral Therapy) (Other)
VR (Virtual reality)
Intervention: VR (Virtual reality) (Behavioral)
CBT+VR (Cognitive behavioral therapy and virtual reality)
Intervention: CBT+VR (Cognitive behavioral therapy and virtual reality) (Other)
Outcomes
Primary Outcomes
Return to Sport After Serious Injury Questionnaire (RSSIQ)
Time Frame: Through study completion, an average of 1 year
This scale was used to assess whether athletes were psychologically ready to return to sport.
Re-Injury Anxiety Inventory (RIAI)
Time Frame: Through study completion, an average of 1 year
This scale measures re-injury anxiety
Sport Injury Rehabilitation Adherence Scale (SIRAS)
Time Frame: Through study completion, an average of 1 year
This scale measures rehabilitation adherence
Athletic Injury Self-Efficacy Questionnaire (AISEQ)
Time Frame: Through study completion, an average of 1 year
This scale measures Self-Efficacy
Tampa Scale for Kinesiophobia
Time Frame: Through study completion, an average of 1 year
This scale measures kinesiophobia
Anterior Cruciate Ligament Return to Sport Scale (ACL-RSI)
Time Frame: Through study completion, an average of 1 year
This scale was used to assess whether athletes were psychologically ready to return to sport from ACL surgery.
Secondary Outcomes
No secondary outcomes reported
Investigators
Hande Turkeri Bozkurt
Principal Investigator
Hacettepe University