Anxiolytic Effectiveness of Virtual Reality Glasses in Surgery

NCT06244654 | Completed

• 1 other identifier: E2-23-4787
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Anesthesia; Anxiety; Postoperative Pain; Postoperative Recovery

Outcome Measures

Primary Outcomes (1)

• State-Trait Anxiety Scale

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

  Preoperative, Postoperative 4.hour

Secondary Outcomes (10)

• systolic blood pressure

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

• diastolic blood pressure

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

• mean arterial pressure

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

• heart rate

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

• oxygen saturation

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

Study Arms (2)

Standart Anesthesia management

OTHER

In 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.

Other: No VR

VR group

EXPERIMENTAL

Oculus 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.

Device: Oculus Quest 2 VR virtual reality glasses and wired over-ear headphones

Interventions

Oculus Quest 2 VR virtual reality glasses and wired over-ear headphones DEVICE

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.

VR group

No VR OTHER

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.

Also known as: Control group

Standart Anesthesia management

Eligibility Criteria

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

You may qualify if:

• who will undergo upper extremity surgery under regional anesthesia

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, Cankaya, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 30577461 BACKGROUND

• 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.

  PMID: 36312886 BACKGROUND

• 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.

  PMID: 31941129 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Pain, Postoperative

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: February 6, 2024
• Study Start: January 25, 2024
• Primary Completion: June 30, 2024
• Study Completion: July 15, 2024
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)