The Effect of Cognitive Behavioral Therapy and Virtual Reality Use in Inured Athletes

Study Overview
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Brief Summary
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Important psychological problems can be experienced after sports injuries such as anterior cruciate ligament (ACL), these delay physical recovery, affect the quality of rehabilitation and eventually cause problems or re-injuries in the process of returning to sports. The most important of these problems are re-injury anxiety, rehabilitation adherence, rehabilitation self-efficacy problems and kinesiophobia. Although some interventions have been proposed for the solution of these problems, a structured intervention approach has not been put forward yet. With this research project, our aim is to examine the effectiveness of the Cognitive Behavioral Therapy (CBT) protocol (CBT+VR) enriched with the contribution of virtual reality (VR). The research will be conducted with 60 athletes who meet the inclusion criteria. In the study, which is planned as a 4X5 (groupXmeasurement) mixed factorial design model with four groups (intervention1-intervention2-intervention3, control), the athletes will be filled with psychological assessment scales in order to collect the first data within the first week of starting physical therapy after ACL operation. The data obtained will be analyzed with multi-level statistics. Whether the anxiety levels of the athletes increase in the VR environment will be monitored with the biofeedback system, which will provide concrete data as well as subjective scales.

Detailed Description
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Psychological problems experienced by athletes after serious injuries have been studied intensively in recent years. Important psychological problems can be experienced after sports injuries such as anterior cruciate ligament (ACL), these delay physical recovery, affect the quality of rehabilitation, and eventually cause problems or re-injuries in the process of returning to sports. The most important of these problems are re-injury anxiety, rehabilitation adherence, rehabilitation self-efficacy problems, and kinesiophobia. Although some interventions have been proposed for the solution of these problems, a structured intervention approach has not been put forward yet. With this research project, our aim is to examine the effectiveness of the Cognitive Behavioral Therapy (CBT) protocol (CBT+VR) enriched with the contribution of virtual reality (VR), which the investigators prepared to intervene in psychological problems that arise after ACL operation. If the CBT+VR protocol is effective, it can be used to increase the quality of physical rehabilitation and therefore to ensure that the perceptions of athletes regarding their psychological outcomes about their return to sport are positive. CBT+VR protocol will be tested, and if it is found effective, it will make a significant contribution to both the literature and practice. The main peculiarity of this study is that a holistic protocol including virtual intervention will be developed for the solution of psychological problems encountered in the rehabilitation process of sports injuries for the first time. The research will be conducted with 60 athletes who meet the inclusion criteria. In the study, which is planned as a 4X5 (groupXmeasurement) mixed factorial design model with four groups (intervention1-intervention2-intervention3, control), the athletes will be filled with psychological assessment scales in order to collect the first data within the first week of starting physical therapy after ACL operation. The CBT+VR protocol will be applied to the first intervention group. Only the behavioral intervention part of the protocol in the VR environment will be applied to the second intervention group. The CBT protocol will be applied without the VR environment for the third intervention group. It is planned that for all intervention groups and the control group, there will be 10 sessions in total once a week, and each session lasts 50 minutes. There will be conversation in the control group sessions; in addition, images that give calmness from nature will be watched for 5 minutes with VR glasses. The remaining 45 minutes will continue with a conversation with encouragement and emotional support, which will not create a therapeutic effect. The scales will also be filled in three more times. The data obtained will be analyzed with multi-level statistics. Whether the anxiety levels of the athletes increase in the VR environment will be monitored with the biofeedback system, which will provide concrete data as well as subjective scales.

Official Title
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The Effect of Cognitive Behavioral Therapy and Virtual Reality Use in Supporting Physical Rehabilitation After Anterior Cruciate Ligament (ACL) Operation

Conditions
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Re-injury Anxiety, Kinesiophobia, Poor Rehabilitation Adherence, Poor Rehabilitation Self Efficacy

Intervention / Treatment
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* Behavioral: CBT+VR (Cognitive behavioral therapy and virtual reality)
* Behavioral: VR (Virtual reality)
* Behavioral: CBT (Cognitive behavioral therapy)
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT+VR (Cognitive behavioral therapy and virtual reality)<br> | Behavioral: CBT+VR (Cognitive behavioral therapy and virtual reality)<br>* The investigators are testing whether this intervention protocol is effective on re-injury anxiety, kinesiophobia, self-efficacy, and adherence problems in athletes who have undergone ACL surgery.<br>|
| Experimental: VR (Virtual reality)<br> | Behavioral: VR (Virtual reality)<br>* The investigators are testing whether this intervention protocol is effective on re-injury anxiety, kinesiophobia, self-efficacy, and adherence problems in athletes who have undergone ACL surgery.<br>|
| Experimental: CBT (Cognitive behavioral therapy)<br> | Behavioral: CBT (Cognitive behavioral therapy)<br>* The investigators are testing whether this intervention protocol is effective on re-injury anxiety, kinesiophobia, self-efficacy, and adherence problems in athletes who have undergone ACL surgery.<br>|
| Placebo Comparator: Control<br> | Behavioral: Control<br>* The investigators are testing whether the placebo control protocol is effective on re-injury anxiety, kinesiophobia, self-efficacy, and adherence problems in athletes who have undergone ACL surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-Injury Anxiety Inventory (RIAI) | This scale measures re-injury anxiety | Through study completion, an average of 1 year | 
| Sport Injury Rehabilitation Adherence Scale (SIRAS) | This scale measures rehabilitation adherence | Through study completion, an average of 1 year | 
| Athletic Injury Self-Efficacy Questionnaire (AISEQ) | This scale measures Self-Efficacy | Through study completion, an average of 1 year | 
| Tampa Scale for Kinesiophobia | This scale measures kinesiophobia | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACL surgery, CBT, VR, Re-injury anxiety, Adherence, Self-efficacy, Kinesiophobia