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Artroscopic SurgeryNCT06906120

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

A study testing Virtual Reality-Based Operating Room Education in people with Artroscopic Surgery and Orthopedic Surgery, run by Acibadem University at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Artroscopic Surgery, Orthopedic Surgery
What is being tested?
Virtual Reality-Based Operating Room Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesTurkey (Türkiye)
Study dates
7 Jul 2025to 25 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites
  • Acibadem Atasehir Hospitla

    Istanbul, Ataşehir, 34642

  • Acibadem Altunizade Hospital

    Istanbul, ataşehir, 34662

Other trials in Turkey (Türkiye)

About this study

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.

Read more

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.

Read the 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.

Being tested
Virtual Reality-Based Operating Room Education
Keywords
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, VR-based operating room introduction, patient education.
Medical subject headings
Patient Satisfaction, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality-Based Operating Room EducationBehavioural

    Also called VR-Based Operating Room Orientation, Virtual Reality Surgical Environment Training

    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.

Study groups in NCT06906120
Study groupRoleWhat they receive
Virtual Reality-Based Education GroupExperimentalNot described
Receives: Behavioral: Virtual Reality-Based Operating Room Education
Standard Education GroupNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Preoperative anxiety level: State Anxiety - State-Trait Anxiety Inventory (STAI-I)

    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.

    Measured: 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.

  2. Patient satisfaction with perioperative care

    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.

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

  3. Surgical fear level: Surgical Fear Questionnaire (SFQ)

    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.

    Measured: Surgical fear was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; and on the day of surgery, before surgery.

Secondary outcomes (8)
  1. Postoperative pain level: Numeric Rating Scale (NRS)

    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.

    Measured: Postoperative pain was assessed within 2 hours after surgery.

  2. Physiological parameters: Heart rate

    Heart rate was assessed in the intervention and control groups.

    Measured: 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.

  3. Electrodermal activity (EDA)

    Electrodermal activity (EDA) was assessed to evaluate physiological arousal in the intervention and control groups. EDA was recorded using a Shimmer3 GSR+ device.

    Measured: 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.

  4. Physiological parameters: Systolic blood pressure

    Systolic blood pressure was assessed in the intervention and control groups.

    Measured: 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.

  5. Physiological parameters: Diastolic blood pressure

    Diastolic blood pressure was assessed in the intervention and control groups.

    Measured: 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.

  6. Physiological parameters: Respiratory rate

    Respiratory rate was assessed in the intervention and control groups.

    Measured: 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.

  7. Physiological parameters: Peripheral oxygen saturation (SpO₂)

    Peripheral oxygen saturation (SpO₂) was assessed in the intervention and control groups.

    Measured: 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.

  8. Physiological parameters: Body temperature

    Body temperature was assessed in the intervention and control groups.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2025
  2. Study start7 Jul 2025
  3. Primary completion25 Oct 2025
  4. Study completion25 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06906120
Sponsor's protocol ID
ORTO2025-VR01
Status last verified
Aug 2026
First submitted
19 Mar 2025
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the study results will be shared with qualified researchers upon reasonable request, subject to ethical and data protection requirements. No personally identifiable information will be shared.

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.

    PubMed 36319521
  • 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.

    PubMed 27931701
  • 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.

    PubMed 32251126
  • 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.

    PubMed 34398809
  • 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.

    PubMed 37589975
  • 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.

    PubMed 33303283
  • 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.

    PubMed 39270596
  • 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.

    PubMed 29705448
  • 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.

    PubMed 33755246
  • 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.

    PubMed 35113840

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality-Based Operating Room Education in people with Artroscopic Surgery and Orthopedic Surgery, run by Acibadem University at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06906120, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.

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