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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAcibadem University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Virtual Reality-Based Operating Room Education

    Behavioral

    For 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

60 Participants
are divided into 2 treatment groups
Group A: Virtual Reality-Based Education GroupExperimental treatment 1 intervention
Group B: Standard Education GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
STAI trait:1 day before surgery, prior to intervention/education STAI state:1.Immediately after STAI-II measurement 2.Immediately after the intervention/education 3.On the day of surgery, prior to premedication 4.Within 2 hours after surgery

Secondary outcomes

1

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.

Time frame
1. Immediately after STAI-I measurement, 2. Immediately after the intervention/education, 3.On the day of surgery, prior to premedication

Other outcomes

1

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.

Time frame
Pain levels will be recorded within the first 2 hours after surgery using the NRS.
2

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

Time frame
Before the intervention, immediately after the intervention, 20 minutes before the transfer to the operating room on the morning of surgery, and 15 minutes after arriving at the inpatient ward.
3

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.

Time frame
Satisfaction will be measured within 2 hours after discharge procedures have started.

Sponsors and contacts

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Acibadem University

Lead sponsor

Acibadem Altunizade Hospital, Istanbul

Collaborator

Acibadem Atasehir Hospital

Collaborator

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