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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06150118
Other study ID # 121K248
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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