- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06906120
The Effect of Operating Room Introduction With Virtual Reality Glasses on Anxiety, Surgical Fear, and Satisfaction Levels in Patients Undergoing Orthopedic Surgery
This study evaluated the effect of an operating room introduction using virtual reality (VR) on anxiety, surgical fear, patient satisfaction, postoperative pain, and physiological parameters in patients undergoing arthroscopic orthopedic surgery.
The intervention consisted of a researcher-developed 360-degree educational video introducing the operating room environment, the surgical team, and the perioperative process. The video was presented using Meta Quest 3 VR goggles. Participants in the intervention group received the VR-based operating room introduction in addition to the institution's standard preoperative education. Participants in the control group received only the institution's standard preoperative education, and no additional intervention was provided.
The study assessed preoperative anxiety, surgical fear, patient satisfaction, postoperative pain, and physiological parameters, including heart rate, blood pressure, respiratory rate, peripheral oxygen saturation, and electrodermal activity. Measurements were obtained at predefined time points before and after the intervention, on the day of surgery, and during the postoperative period.
The study was conducted as a randomized controlled trial with 60 participants, with 30 participants assigned to the intervention group and 30 participants assigned to the control group.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study was conducted as a randomized controlled trial in patients undergoing arthroscopic orthopedic surgery. The intervention group received a researcher-developed operating room introduction video presented through virtual reality (VR) goggles, in addition to the institution's standard preoperative education. The control group received only the institution's standard preoperative education, and no additional intervention was provided.
The operating room introduction video was recorded from the patient's perspective using an Insta360 X4 camera. The final video was 9 minutes and 22 seconds in duration and was presented using Meta Quest 3 VR goggles. The video provided a 360-degree view of the operating room environment and introduced the perioperative process from the patient's perspective.
The video included the patient's transfer from the hospital room to the operating room, encounters with the healthcare team, patient identification procedures, transfer to the operating room area, introduction to the operating room environment, surgical preparation, anesthesia-related procedures, and the perioperative process. The content was designed to familiarize patients with the operating room environment and the sequence of events they would experience during the perioperative period.
The VR intervention was administered to participants in the intervention group before surgery. The VR goggles were appropriately disinfected before use. A researcher remained available during the intervention to assist the participant and ensure the safe use of the VR equipment.
The study included 60 participants who were randomly assigned to either the intervention group or the control group, with 30 participants in each group. Data were collected at predefined time points before and after the intervention, on the day of surgery, and during the postoperative period. The study evaluated anxiety, surgical fear, patient satisfaction, postoperative pain, and physiological parameters, including heart rate, blood pressure, respiratory rate, peripheral oxygen saturation, and electrodermal activity.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ataşehir
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Istanbul, Ataşehir, Turkey (Türkiye), 34642
- Acibadem Atasehir Hospitla
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ataşehir
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Istanbul, ataşehir, Turkey (Türkiye), 34662
- Acibadem Altunizade Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18-65 years
- Arthroscopic orthopedic surgery planned
- General anesthesia planned
- Conscious and fully oriented to person, place, and time
- No communication difficulties
- No neurological or psychiatric disorders
- No severe visual or hearing impairment
- No history of vertigo or recurrent dizziness
Exclusion Criteria:
- Inability to communicate with the patient
- Administration of premedication before completion of the study measurements
- Conversion to open surgery during the procedure
- Development of a life-threatening health problem after surgery
- Withdrawal from the study
Study Plan
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 |
|---|---|
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Experimental: Virtual Reality-Based Education Group
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For the Intervention Group: The intervention consisted of a researcher-developed 360-degree virtual reality operating room education video. The 9-minute 22-second video was recorded from the patient's perspective using an Insta360 X4 camera and presented with Meta Quest 3 VR headsets. It included transfer from the ward, handover to the surgical team, transfer to the operating table, safety and monitoring, anesthesia induction, emergence from anesthesia, and transfer to the ward. At relevant points, perioperative information was provided through researcher-prepared voice-over narration integrated into the video. Participants watched the video once on an examination bed/stretcher in examination rooms, positioned at approximately 30-45 degrees with a pillow under the head. A disposable hygienic headset strap cover was used. The same device, procedure, and video were used. The VR education was provided in addition to the institution's standard preoperative education.
Other Names:
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No Intervention: Standard Education Group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Preoperative anxiety level: State Anxiety - State-Trait Anxiety Inventory (STAI-I)
Time Frame: STAI-I was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; on the day of surgery, before surgery; and within 2 hours after surgery.
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State anxiety will be assessed using the State Anxiety subscale of the State-Trait Anxiety Inventory (STAI-I).
The STAI-I consists of 20 items rated on a 4-point Likert-type scale, with total scores ranging from 20 to 80. Higher scores indicate higher levels of state anxiety.
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STAI-I was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; on the day of surgery, before surgery; and within 2 hours after surgery.
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Patient satisfaction with perioperative care
Time Frame: Satisfaction will be measured within 2 hours after discharge procedures have started.
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Patient satisfaction with perioperative care will be assessed using a 10-point satisfaction scale.
Scores range from 1 to 10, with higher scores indicating higher satisfaction.
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Satisfaction will be measured within 2 hours after discharge procedures have started.
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Surgical fear level: Surgical Fear Questionnaire (SFQ)
Time Frame: Surgical fear was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; and on the day of surgery, before surgery.
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Surgical fear was assessed using the Surgical Fear Questionnaire (SFQ).
The SFQ consists of 8 items rated on an 11-point scale from 0 (not afraid at all) to 10 (very afraid).
The total score ranges from 0 to 80, with higher scores indicating greater surgical fear.
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Surgical fear was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; and on the day of surgery, before surgery.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Postoperative pain level: Numeric Rating Scale (NRS)
Time Frame: Postoperative pain was assessed within 2 hours after surgery.
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This measure compared postoperative pain levels between the virtual reality education and standard education groups. Pain level was 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. |
Postoperative pain was assessed within 2 hours after surgery.
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Physiological parameters: Heart rate
Time Frame: Heart rate was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; on the day of surgery, before surgery; and at the first and second hours after admission to the inpatient ward.
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Heart rate was assessed in the intervention and control groups.
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Heart rate was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; on the day of surgery, before surgery; and at the first and second hours after admission to the inpatient ward.
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Electrodermal activity (EDA)
Time Frame: Before and after the intervention (3 min each), on the morning of surgery before transfer (3 min), and continuously during ward-to-OR transfer, from transfer start to handover completion.
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Electrodermal activity (EDA) was assessed to evaluate physiological arousal in the intervention and control groups.
EDA was recorded using a Shimmer3 GSR+ device.
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Before and after the intervention (3 min each), on the morning of surgery before transfer (3 min), and continuously during ward-to-OR transfer, from transfer start to handover completion.
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Physiological parameters: Systolic blood pressure
Time Frame: Systolic blood pressure was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; on the day of surgery, before surgery; and at the first and second hours after admission to the inpatient ward.
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Systolic blood pressure was assessed in the intervention and control groups.
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Systolic blood pressure was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; on the day of surgery, before surgery; and at the first and second hours after admission to the inpatient ward.
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Physiological parameters: Diastolic blood pressure
Time Frame: Diastolic blood pressure was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; on the day of surgery, before surgery; and at the first and second hours after admission to the inpatient ward.
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Diastolic blood pressure was assessed in the intervention and control groups.
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Diastolic blood pressure was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; on the day of surgery, before surgery; and at the first and second hours after admission to the inpatient ward.
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Physiological parameters: Respiratory rate
Time Frame: Respiratory rate was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; on the day of surgery, before surgery; and at the first and second hours after admission to the inpatient ward.
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Respiratory rate was assessed in the intervention and control groups.
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Respiratory rate was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; on the day of surgery, before surgery; and at the first and second hours after admission to the inpatient ward.
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Physiological parameters: Peripheral oxygen saturation (SpO₂)
Time Frame: Peripheral oxygen saturation (SpO₂) was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; on the day of surgery, before surgery; and at the first and second hours after admission to the inpatient ward.
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Peripheral oxygen saturation (SpO₂) was assessed in the intervention and control groups.
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Peripheral oxygen saturation (SpO₂) was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; on the day of surgery, before surgery; and at the first and second hours after admission to the inpatient ward.
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Physiological parameters: Body temperature
Time Frame: Body temperature was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; on the day of surgery, before surgery; and at the first and second hours after admission to the inpatient ward.
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Body temperature was assessed in the intervention and control groups.
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Body temperature was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; on the day of surgery, before surgery; and at the first and second hours after admission to the inpatient ward.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Trait anxiety level: State-Trait Anxiety Inventory (STAI-II)
Time Frame: 24-48 hours before surgery, prior to the intervention/education.
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Trait anxiety was assessed using the STAI-II subscale of the State-Trait Anxiety Inventory.
The STAI-II consists of 20 items scored on a 4-point Likert-type scale, with total scores ranging from 20 to 80. Higher scores indicate higher levels of trait anxiety.
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24-48 hours before surgery, prior to the intervention/education.
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Patient satisfaction
- Pain management
- Virtual reality
- Pain assessment
- Physiological parameters
- Electrodermal activity
- Orthopedic surgery
- Surgical anxiety
- Preoperative education
- Surgical fear
- Surgical preparation
- VR intervention
- Patient education tools
- Preoperative anxiety reduction
- VR-based operating room introduction
- patient education.
Additional Relevant MeSH Terms
Other Study ID Numbers
- ORTO2025-VR01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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