Clinical Trials Directory

Trials / Completed

CompletedNCT06150118

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Hacettepe University · Academic / Other
Sex
All
Age
18 Years – 45 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
OTHERCBT+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.
BEHAVIORALControl (placebo) groupThe 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.
BEHAVIORALVR (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.
OTHERCBT (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.

Timeline

Start date
2023-04-05
Primary completion
2025-02-07
Completion
2025-02-07
First posted
2023-11-29
Last updated
2026-01-14

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06150118. Inclusion in this directory is not an endorsement.