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

NCT06150118 | Completed

• 1 other identifier: 121K248
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Kinesiophobia; Poor Rehabilitation Adherence; Poor Rehabilitation Self Efficacy; Return to Sport; Re-injury Anxiety

Keywords

Re-injury anxiety; Adherence; Self-efficacy; Kinesiophobia; psychological readiness to return to sport

Outcome Measures

Primary Outcomes (6)

• 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

• Return to Sport After Serious Injury Questionnaire (RSSIQ)

  This scale was used to assess whether athletes were psychologically ready to return to sport.

  Through study completion, an average of 1 year

• Anterior Cruciate Ligament Return to Sport Scale (ACL-RSI)

  This scale was used to assess whether athletes were psychologically ready to return to sport from ACL surgery.

  Through study completion, an average of 1 year

Study Arms (5)

CBT+VR (Cognitive behavioral therapy and virtual reality)

EXPERIMENTAL

Other: CBT+VR (Cognitive behavioral therapy and virtual reality)

Control

PLACEBO COMPARATOR

Behavioral: Control (placebo) group

Control Group

NO INTERVENTION

This arm have no intervention during the research. They only had been followed up by researchers

CBT (Cognitive Behavioral Therapy)

EXPERIMENTAL

Other: CBT (Cognitive Behavioral Therapy)

VR (Virtual reality)

EXPERIMENTAL

Behavioral: VR (Virtual reality)

Interventions

Control (placebo) group BEHAVIORAL

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.

Control

CBT+VR (Cognitive behavioral therapy and virtual reality) OTHER

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+VR (Cognitive behavioral therapy and virtual reality)

VR (Virtual reality) BEHAVIORAL

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)

CBT (Cognitive Behavioral Therapy) OTHER

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)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Having a discomfort that prevents participants from participating in VR sessions (panic attack, epilepsy, etc.)
• Having decided to quit sports even if participants will continue rehabilitation after the operation

Sponsors & Collaborators

• Hacettepe University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Hacettepe University

Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kinesiophobia

Interventions

Cognitive Behavioral Therapy; Population Groups

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Demography; Population Characteristics

Study Officials

• Ziya Koruç, PhD

  Hacettepe University

  STUDY DIRECTOR

• Britton W. Brewer, PhD

  Springfield College

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 29, 2023
• Study Start: April 5, 2023
• Primary Completion: February 7, 2025
• Study Completion: February 7, 2025
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)