About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals aged 18-65 years
Patients scheduled for arthroscopic surgery
Those who have not undergone any previous surgical procedures
Patients who will undergo surgery under general anesthesia
Disqualifiers
Inability to communicate with the patients
Development of a life-threatening health problem after surgery
Transition to open surgery during the procedure
Patients who wish to withdraw from the study
Trial design
Parallel
Treatments tested in this trial
Virtual Reality-Based Operating Room Education
BehavioralFor the Intervention Group: Written informed consent will be obtained one day before surgery when patients visit the anesthesia clinic. Subsequently, the Patient Introduction Form, State-Trait Anxiety Inventory (STAI-I, STAI-II), and Surgical Fear Scale will be completed, and electrodermal activity data and physiological parameters will be recorded for 5 minutes. Participants will watch a 3D training video created by the researcher using Meta Quest 3 virtual reality headsets. This video will provide an introduction to the operating room environment and related procedures. After the video, physiological parameters will be recorded again, and STAI-I and the Surgical Fear Scale will be completed. On the day of the surgery, after the patients are admitted and necessary preparations are made, STAI-I and the Surgical Fear Scale will be completed again, and physiological parameters will be recorded. Electrodermal activity data will be recorded 15-20 minutes before anesthesia is administ
Treatment groups
Trial outcomes
Primary outcomes
Preoperative anxiety level: State-Trait Anxiety Inventory - STAI
State-Trait Anxiety Inventory (STAI-I and STAI-II): This inventory measures individuals' current (state) anxiety levels and general (trait) anxiety tendencies. Both forms consist of 20 items and use a 4-point Likert-type response scale. Score range: Varies between 20 and 80. Higher scores: Indicate higher anxiety levels. Lower scores: Indicate lower anxiety levels.
Secondary outcomes
Surgical fear level: Measured using the Surgical Fear Scale
The change in surgical fear levels in the intervention and control groups will be assessed. Surgical Fear Scale (SFS); scores range from 0 to 100, with higher scores indicating greater fear.
Other outcomes
Pain level: Measured using the Numeric Rating Scale (NRS)
This measure will compare the postoperative pain levels between the virtual reality education and standard education groups. Pain level will be assessed using the Numerical Rating Scale (NRS). Minimum Value: 0 (No Pain) Maximum Value: 10 (Worst Pain) Higher Scores: Indicate worse outcomes, meaning more severe pain.
Physiological parameters: Measured using electrodermal activity (EDA), heart rate, blood pressure (systolic and diastolic), respiratory rate, and peripheral oxygen saturation (SpO2).
This measure will assess the physiological responses (electrodermal activity, heart rate, blood pressure, respiratory rate, and SpO2) in patients after virtual reality education and standard education
Satisfaction
Patient satisfaction will be assessed using a satisfaction scale. Satisfaction with the intervention will be assessed using the Satisfaction Scale. Minimum Value: 1 (Very Dissatisfied) Maximum Value: 10 (Very Satisfied) Higher Scores: Indicate better outcomes, meaning higher satisfaction levels.
Sponsors and contacts
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Acibadem University
Lead sponsor
Acibadem Altunizade Hospital, Istanbul
Collaborator
Acibadem Atasehir Hospital
Collaborator
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