NCT06906120

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Acibadem University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Artroscopic Surgery
• Orthopedic Surgery

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-04-20
• Primary completion: 2025-11-15
• Completion: 2025-11-15
• First posted: 2025-04-02
• Last updated: 2025-04-18

Locations

2 sites across 1 country: Turkey (Türkiye)