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AnesthesiaNCT06244654

Anxiolytic Effectiveness of Virtual Reality Glasses in Surgery

A study testing Oculus Quest 2 VR virtual reality glasses and wired over-ear headphones and No VR in people with Anesthesia and Anxiety, run by Ankara City Hospital Bilkent at 1 site 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

Regional anesthesia allows surgery without affecting the patient's level of consciousness.However, this may cause anxiety in some patients.In previous research, scientists have tried to prevent anxiety with non-pharmacological interventions such as music and cognitive therapies.Virtual reality is thought to offer an… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anesthesia, Anxiety, Postoperative Pain
What is being tested?
Oculus Quest 2 VR virtual reality glasses and wired over-ear headphones and No VR
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 Jan 2024to 15 Jul 2024
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • who will undergo upper extremity surgery under regional anesthesia

Who cannot join

  • being under 18 years old
  • Those who do not have the ability to read, understand and sign the consent form
  • An active infection or open wound in the face or eye area
  • History of seizures due to an epileptic condition or any other reason
  • Planning to wear a hearing aid during the surgical procedure
  • Having a pacemaker or other implanted medical device
Show all 12Show fewer
  • Migraine
  • Having an infectious condition that is transmitted through droplets or airborne
  • not knowing Turkish
  • Not deemed suitable for the approach by the surgeon
  • History of psychosis or claustrophobia
  • Being visually and/or hearing impaired

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Ankara City Hospital

    Ankara, Cankaya

Other trials in Turkey (Türkiye)

About this study

Official title: Anxiolytic Effectiveness of Virtual Reality Glasses in Upper Extremity Surgery

Regional anesthesia allows surgery without affecting the patient's level of consciousness.However, this may cause anxiety in some patients.In previous research, scientists have tried to prevent anxiety with non-pharmacological interventions such as music and cognitive therapies.Virtual reality is thought to offer an immersive experience that can alter the mind's perception of pain. Scientists have found in previous preliminary studies that virtual reality is safe and effective as an adjunct to standard sedative/analgesic protocols for reducing patients' pain and anxiety during endoscopy, colonoscopy, dental treatments, burn dressings, and labor. In this study, it is expected that anxiety scores, postoperative analgesic need and intraoperative sedation need will decrease, recovery quality will improve and patient satisfaction will increase in patients who will undergo upper extremity surgery under regional anesthesia and watch videos through VR glasses.

Being tested
Oculus Quest 2 VR virtual reality glasses and wired over-ear headphones, No VR
Medical subject headings
Anxiety Disorders, Pain, Postoperative

What participants receive

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

  • Oculus Quest 2 VR virtual reality glasses and wired over-ear headphonesDevice

    After the VR group comes to the preoperative area and is evaluated, they will be asked to wear VR glasses and headphones. VR glasses and headphones were worn on the patient during peripheral nerve block applications and the operation. At the end of the operation, the VR glasses and headphones were removed and they were taken to the postoperative recovery room.

  • No VROther

    Also called Control group

    After evaluation of the patients taken to the preoperative area, routine peripheral nerve block application was performed without the use of VR glasses. VR glasses were not worn during the operation, as is the routine protocol. At the end of the surgery, they were taken to the postoperative recovery room.

Study groups in NCT06244654
Study groupRoleWhat they receive
Standart Anesthesia managementOtherIn the non-VR group, the standard anesthesia procedure will be followed. Brachial plexus nerve block will be performed with a 50mm peripheral block needle (Vygon echoplex+ 22Gx50mm) with a mixture of 2% lidocaine and 0.5% bupivacaine (10 mL each) prepared as 20ml. After waiting for a sufficient time, the nerve block effectiveness of the patients will be measured by Modified Broomage scale and pinprick. Additional sedative agents may be applied to both groups at the discretion of the anesthesiologist and will be recorded. Anesthesia management will be applied to both groups in accordance with the standard working order of the Anesthesia clinic.
Receives: Other: No VR
VR groupExperimentalOculus Quest 2 VR virtual reality glasses and wired over-ear headphones will be used for patients to hear the sounds of the immersive environment and to block the sounds coming from the operating room environment. Brachial plexus nerve block will be performed with a 50mm peripheral block needle (Vygon echoplex+ 22Gx50mm) with a mixture of 2% lidocaine and 0.5% bupivacaine (10 mL each) prepared as 20ml. After waiting for a sufficient time, the nerve block effectiveness of the patients will be measured by Modified Broomage scale and pinprick.Additional sedative agents may be applied to both groups at the discretion of the anesthesiologist and will be recorded. Anesthesia management will be applied to both groups in accordance with the standard working order of the Anesthesia clinic.
Receives: Device: Oculus Quest 2 VR virtual reality glasses and wired over-ear headphones

What is being measured

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

  1. State-Trait Anxiety Scale

    preoperative and postoperative STAI I and II score questions will be asked.

    Measured: Preoperative, Postoperative 4.hour

Secondary outcomes (10)

  1. systolic blood pressure

    non invasive systolic blood pressure measurement

    Measured: Preoperative, İntraoperative 0 min, İntraoperative 60min, End of Operation, Postoperative 4.hour

  2. diastolic blood pressure

    non invasive diastolic blood pressure measurement

    Measured: Preoperative, İntraoperative 0 min, İntraoperative 60min, End of Operation, Postoperative 4.hour

  3. mean arterial pressure

    mean blood pressure measurement

    Measured: Preoperative, İntraoperative 0 min, İntraoperative 60min, End of Operation, Postoperative 4.hour

  4. heart rate

    intraoperatif and perioperatif ecg monitarization

    Measured: Preoperative, İntraoperative 0 min, İntraoperative 60min, End of Operation, Postoperative 4.hour

  5. oxygen saturation

    intraoperatif and perioperative pulse oxymeter measurement

    Measured: Preoperative, İntraoperative 0 min, İntraoperative 60min, End of Operation, Postoperative 4.hour

  6. aditional analgesic requirement

    postoperative additional analgesic requirement

    Measured: postoperative up to 24 hour

  7. VAS score

    A blinded evaluator will evaluate the visual analog scale score.

    Measured: Postoperative 1.hour, 4.hour., 12.hour., 24hour.

  8. Patient satisfaction scale

    A blinded evaluator will evaluate the Patient satisfaction scale

    Measured: Postoperative 4.hour

  9. Surgeon satisfaction scale

    A blinded evaluator will evaluate the surgeon satisfaction scale

    Measured: Postoperativ 1.hour

  10. The quality of recovery-15 (QoR-15)

    A blinded evaluator will evaluate the QoR-15 scale.

    Measured: Preoperative, Postoperative 24.hour

Timeline

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

  1. First posted6 Feb 2024
  2. Study start25 Jan 2024
  3. Primary completion30 Jun 2024
  4. Study completion15 Jul 2024

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06244654
Sponsor's protocol ID
E2-23-4787
Status last verified
Jan 2025
First submitted
19 Jan 2024
Last updated
6 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Moon JY, Shin J, Chung J, Ji SH, Ro S, Kim WH. Virtual Reality Distraction during Endoscopic Urologic Surgery under Spinal Anesthesia: A Randomized Controlled Trial. J Clin Med. 2018 Dec 20;8(1):2. doi: 10.3390/jcm8010002.

    PubMed 30577461

  • Barry KS, Nimma SR, Spaulding AC, Wilke BK, Torp KD, Ledford CK. Perioperative Outcomes of Immersive Virtual Reality as Adjunct Anesthesia in Primary Total Hip and Knee Arthroplasty. Arthroplast Today. 2022 Oct 22;18:84-88. doi: 10.1016/j.artd.2022.09.015. eCollection 2022 Dec.

    PubMed 36312886

  • Alaterre C, Duceau B, Sung Tsai E, Zriouel S, Bonnet F, Lescot T, Verdonk F. Virtual Reality for PEripheral Regional Anesthesia (VR-PERLA Study). J Clin Med. 2020 Jan 13;9(1):215. doi: 10.3390/jcm9010215.

    PubMed 31941129

  • Kose M, Nalbant B, Kavak Akelma F. Anxiolytic effect of virtual reality headset in upper extremity surgery: a prospective randomized trial. BMC Surg. 2025 Dec 27;26(1):87. doi: 10.1186/s12893-025-03448-w.

    PubMed 41455966

Questions about this trial

What is this clinical trial studying?

A study testing Oculus Quest 2 VR virtual reality glasses and wired over-ear headphones and No VR in people with Anesthesia and Anxiety, run by Ankara City Hospital Bilkent at 1 site 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 1 inclusion and 12 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 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

State-Trait Anxiety Scale (time frame: Preoperative, Postoperative 4.hour). 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 NCT06244654, which also lists 4 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 6 Jan 2025.

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