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

April 15, 2025 updated by: Rana Güngör Sevinç, Acibadem University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized controlled trial to be conducted on patients undergoing arthroscopic surgery. The intervention group will be shown a 9,5 minute virtual reality (VR) content, created by the researcher, through VR goggles. The video content will be recorded by the researcher and a team using an Insta360 Pro device. The content will be a simulation involving healthcare professionals in various roles. The footage will be taken from the patient's perspective.

Once the operating room introduction video is completed, expert opinions will be gathered from 10 professionals in the field. Among the experts, 2 will be academicians, 2 will be experienced operating room nurses with at least 10 years of experience, 2 will be orthopedic surgeons, 1 will be a patient who has undergone arthroscopic surgery, 1 will be an anesthesiologist, and 1 will be an anesthesia technician. If the validity index from expert feedback is at least 80%, the video will be finalized.

Before the training content is shown, the VR goggles will be sanitized using an appropriate antiseptic solution, and then placed on the patient. The training content will consist of a 3D operating room introduction video. The device to be used for this training is a portable VR headset developed by Meta. It offers an advanced VR experience with its Snapdragon XR2 Gen 2 processor and high-resolution screens. Additionally, the device complies with the European Union's CE marking requirements and the Federal Communications Commission (FCC) regulations in the United States.

The introduction video will feature a patient's perspective and will detail the entire process up until the administration of anesthesia. During the video, the nurse will provide simultaneous narration, which will be heard by the patient through headphones. The content of the video will cover processes such as the patient's exit from the hospital room, transfer to the operating room, surgical safety procedures, introduction of devices used in surgery, prevention of pressure ulcers and hypothermia, and monitoring stages. The nurse will remain with the patient throughout the training.

After the training content is shown, measurements will be taken using the scales at specified time intervals. The study will compare the differences in surgical fear, anxiety levels, physiological parameters, pain levels, and satisfaction between the control group and the intervention group.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Ataşehir
      • İstanbul, Ataşehir, Turkey, 34642
        • Acibadem Atasehir Hospitla
      • İstanbul, Ataşehir, Turkey, 34662
        • Acibadem Altunizade Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • Individuals without communication barriers
  • Patients with clear consciousness, and orientation to person, place, and time
  • Those with no neurological or psychiatric disorders
  • Individuals with no severe visual or auditory impairments

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality-Based Education Group
Behavioral: Virtual Reality-Based Operating Room Education

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

Other Names:
  • VR-Based Operating Room Orientation
  • Virtual Reality Surgical Environment Training
No Intervention: Standard Education Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative anxiety level: State-Trait Anxiety Inventory - STAI
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

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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical fear level: Measured using the Surgical Fear Scale
Time Frame: 1. Immediately after STAI-I measurement, 2. Immediately after the intervention/education, 3.On the day of surgery, prior to premedication
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.
1. Immediately after STAI-I measurement, 2. Immediately after the intervention/education, 3.On the day of surgery, prior to premedication

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain level: Measured using the Numeric Rating Scale (NRS)
Time Frame: Pain levels will be recorded within the first 2 hours after surgery using the 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.
Pain levels will be recorded within the first 2 hours after surgery using the NRS.
Physiological parameters: Measured using electrodermal activity (EDA), heart rate, blood pressure (systolic and diastolic), respiratory rate, and peripheral oxygen saturation (SpO2).
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.
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
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.
Satisfaction
Time Frame: Satisfaction will be measured within 2 hours after discharge procedures have started.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Collaborators

Acibadem Altunizade Hospital, Istanbul
Acibadem Atasehir Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 20, 2025

Primary Completion (Estimated)

November 15, 2025

Study Completion (Estimated)

November 15, 2025

Study Registration Dates

First Submitted

March 19, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

April 2, 2025

Study Record Updates

Last Update Posted (Actual)

April 18, 2025

Last Update Submitted That Met QC Criteria

April 15, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORTO2025-VR01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to share the data through open access in the relevant journal, after anonymizing the data. No personally identifiable information will be included, and only anonymized data will be shared. We plan to make the data accessible on the journal's data platform after the publication date of the study.

IPD Sharing Time Frame

Start Date: 01.01.2026 (When the publication process begins) End Date: 01.07.2026 (6 months after publication)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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