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

Kinesiophobia Clinical Trial

— CBT+VR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06150118
• Other study ID #: 121K248
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2023
• Est. completion date: November 15, 2024

Study information

• Verified date: November 2023
• Source: Hacettepe University
• Contact: Hande Turkeri-Bozkurt, MA
• Phone: +905325862463
• Email: hturkeri[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: November 15, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Kinesiophobia

Intervention

Behavioral:
• CBT+VR (Cognitive behavioral therapy and virtual reality)
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.
• VR (Virtual reality)
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.
• CBT (Cognitive behavioral therapy)
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.
• Control
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.

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (3)

Lead Sponsor	Collaborator
Hacettepe University	Hacettepe University Scientific Research Projects Coordination Unit, THE SCIENTIFIC AND TECHNOLOGICAL RESEARCH COUNCIL OF TÜRKIYE (TUBITAK)

Country where clinical trial is conducted

Turkey, 

Outcome

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