Clinical trial NCT06150118: The Effect of Cognitive Behavioral Therapy and Virtual Reality Use in Inured Athletes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Re-injury Anxiety
Kinesiophobia
Poor Rehabilitation Adherence
Poor Rehabilitation Self Efficacy
Return to Sport
Keywords: Re-injury anxiety
Adherence
Self-efficacy
Kinesiophobia
psychological readiness to return to sport
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
name: Hacettepe University Scientific Research Projects Coordination Unit
First posted: 2023-11-29
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 36 athletes to test its effectiveness. The study consisted of 1 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).

Eligibility criteria: 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 Motion Sickness Susceptibility (The athlete's score from the " Motion Sickness Susceptibility Questionnaire" will be decisive.)
* Having decided to quit sports even if participants will continue rehabilitation after the operation

Primary outcomes:
measure: Re-Injury Anxiety Inventory (RIAI)
timeFrame: Through study completion, an average of 1 year
measure: Sport Injury Rehabilitation Adherence Scale (SIRAS)
timeFrame: Through study completion, an average of 1 year
measure: Athletic Injury Self-Efficacy Questionnaire (AISEQ)
timeFrame: Through study completion, an average of 1 year
measure: Tampa Scale for Kinesiophobia
timeFrame: Through study completion, an average of 1 year
measure: Return to Sport After Serious Injury Questionnaire (RSSIQ)
timeFrame: Through study completion, an average of 1 year
measure: Anterior Cruciate Ligament Return to Sport Scale (ACL-RSI)
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Ziya Koruç, Dr.
role: STUDY_DIRECTOR
References: