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

NCT06906120 | Not Yet Recruiting

• 1 other identifier: ORTO2025-VR01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Artroscopic Surgery; Orthopedic Surgery

Keywords

virtual reality illustration; Orthopedic surgery; Virtual reality; Surgical anxiety; Surgical fear; Preoperative education; Patient satisfaction; Pain management; Physiological parameters; Surgical preparation; VR intervention; Pain assessment; Electrodermal activity; Patient education tools; Preoperative anxiety reduction

Outcome Measures

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.

  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

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

Other Outcomes (3)

• Pain level: Measured using the Numeric Rating Scale (NRS)

  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).

  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

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

Study Arms (2)

Virtual Reality-Based Education Group

EXPERIMENTAL

Behavioral: Virtual Reality-Based Operating Room Education

Standard Education Group

NO INTERVENTION

Interventions

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

Also known as: VR-Based Operating Room Orientation, Virtual Reality Surgical Environment Training

Virtual Reality-Based Education Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acibadem University: lead
• Acibadem Altunizade Hospital, Istanbul: collaborator
• Acibadem Atasehir Hospital: collaborator

Study Sites (2)

Acibadem Atasehir Hospitla

Istanbul, Ataşehir, 34642, Turkey (Türkiye)

Location

Acibadem Altunizade Hospital

Istanbul, ataşehir, 34662, Turkey (Türkiye)

Location

Related Publications (10)

• Ugras GA, Kanat C, Yaman Z, Yilmaz M, Turkmenoglu MO. The Effects of Virtual Reality on Preoperative Anxiety in Patients Undergoing Colorectal and Abdominal Wall Surgery: A Randomized Controlled Trial. J Perianesth Nurs. 2023 Apr;38(2):277-283. doi: 10.1016/j.jopan.2022.07.005. Epub 2022 Oct 29.

  PMID: 36319521 BACKGROUND

• Gursoy A, Candas B, Guner S, Yilmaz S. Preoperative Stress: An Operating Room Nurse Intervention Assessment. J Perianesth Nurs. 2016 Dec;31(6):495-503. doi: 10.1016/j.jopan.2015.08.011. Epub 2016 May 6.

  PMID: 27931701 BACKGROUND

• Delaney LD, Clauw DJ, Waljee JF. The Management of Acute Pain for Musculoskeletal Conditions: The Challenges of Opioids and Opportunities for the Future. J Bone Joint Surg Am. 2020 May 20;102 Suppl 1(Suppl 1):3-9. doi: 10.2106/JBJS.20.00228. No abstract available.

  PMID: 32251126 BACKGROUND

• Morgan H, Nana M, Phillips D, Gallagher S. The Effect of a VIrtual RealiTy Immersive Experience Upon Anxiety Levels, Procedural Understanding, and Satisfaction in Patients Undergoing CArdiac CaTHeterization: The VIRTUAL CATH Trial. J Invasive Cardiol. 2021 Sep;33(9):E681-E686. doi: 10.25270/jic/20.00664. Epub 2021 Aug 8.

  PMID: 34398809 BACKGROUND

• Rizzo MG Jr, Costello JP 2nd, Luxenburg D, Cohen JL, Alberti N, Kaplan LD. Augmented Reality for Perioperative Anxiety in Patients Undergoing Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2329310. doi: 10.1001/jamanetworkopen.2023.29310.

  PMID: 37589975 BACKGROUND

• Cheng JYJ, Wong BWZ, Chin YH, Ong ZH, Ng CH, Tham HY, Samarasekera DD, Devi KM, Chong CS. Preoperative concerns of patients undergoing general surgery. Patient Educ Couns. 2021 Jun;104(6):1467-1473. doi: 10.1016/j.pec.2020.11.010. Epub 2020 Nov 21.

  PMID: 33303283 BACKGROUND

• Chan SL, Sit JWH, Ang WW, Lau Y. Virtual reality-enhanced interventions on preoperative anxiety symptoms in adults undergoing elective surgery: A meta-analysis and meta-regression. Int J Nurs Stud. 2024 Dec;160:104886. doi: 10.1016/j.ijnurstu.2024.104886. Epub 2024 Aug 30.

  PMID: 39270596 BACKGROUND

• Ugras GA, Yildirim G, Yuksel S, Ozturkcu Y, Kuzdere M, Oztekin SD. The effect of different types of music on patients' preoperative anxiety: A randomized controlled trial. Complement Ther Clin Pract. 2018 May;31:158-163. doi: 10.1016/j.ctcp.2018.02.012. Epub 2018 Feb 17.

  PMID: 29705448 BACKGROUND

• Ruiz Hernandez C, Gomez-Urquiza JL, Pradas-Hernandez L, Vargas Roman K, Suleiman-Martos N, Albendin-Garcia L, Canadas-De la Fuente GA. Effectiveness of nursing interventions for preoperative anxiety in adults: A systematic review with meta-analysis. J Adv Nurs. 2021 Aug;77(8):3274-3285. doi: 10.1111/jan.14827. Epub 2021 Mar 23.

  PMID: 33755246 BACKGROUND

• Leland DP, Pareek A, Therrien E, Wilbur RR, Stuart MJ, Krych AJ, Levy BA, Camp CL. Neurological Complications Following Arthroscopic and Related Sports Surgery: Prevention, Work-up, and Treatment. Sports Med Arthrosc Rev. 2022 Mar 1;30(1):e1-e8. doi: 10.1097/JSA.0000000000000322.

  PMID: 35113840 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction; Agnosia

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Rana Güngör Sevinç, Uzman Hemşire

CONTACT

+905382860008; rana.sevinc@acibadem.edu.tr

Sonay Göktaş, Prof. Dr.

CONTACT

+905324567776; sonay.goktas@sbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Rana Güngör Sevinç

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: April 2, 2025
• Study Start: April 20, 2025
• Primary Completion: November 15, 2025
• Study Completion: November 15, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Start Date: 01.01.2026 (When the publication process begins) End Date: 01.07.2026 (6 months after publication)

Locations

TU (2)