Clinical Trial

The Effect of Operating Room Introduction With Virtual Reality Glasses on Anxiety, Surgical Fear, and Satisfaction Levels in Patients Undergoing Orthopedic Surgery

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Record status
This record was last updated April 18, 2025 (before its estimated November 15, 2025 completion). Its status may not reflect the trial's current state.
Summary
This study aims to evaluate the effects of an operating room tour conducted using virtual reality (VR) goggles on anxiety, surgical fear, post-operative pain, satisfaction levels, and physiological parameters in patients undergoing orthopedic surgery. The intervention will involve a 360 degree educational video introducing the operating room environment, surgical team roles, and expected patient experience during the perioperative period. This video will be presented using Meta Quest 3 VR goggles. Participants in the intervention group will watch this video before surgery, while the control group will receive standard preoperative education. The primary outcomes include changes in preoperative anxiety (STAI-I), surgical fear (Surgical Fear Scale), and physiological parameters (e.g., heart rate, blood pressure, and electrodermal activity). Secondary outcomes include post-operative pain and patient satisfaction. Data will be collected at multiple time points, including before and after the intervention, on the day of surgery, and during the postoperative period. The study is designed as a randomized controlled trial with a sample size of 60 participants, equally distributed between intervention and control groups. Data analysis will include appropriate statistical tests based on variable distribution and group comparisons.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-03-25; most recent amendment 2025-04-15.
Trial Details
NCT Number NCT06906120
Lead Sponsor Acibadem University
Collaborators: Acibadem Altunizade Hospital, Istanbul, Acibadem Atasehir Hospital
Conditions Artroscopic Surgery, Orthopedic Surgery
Enrollment 60 participants
Start Date 2025-04-20
Primary Completion 2025-11-15 (estimated)
Study Completion 2025-11-15 (estimated)
Updated on ClinicalTrials.gov 2025-04-18