Anxiolytic Effectiveness of Virtual Reality Glasses in Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Anxiety; Anesthesia; Postoperative Recovery
• Intervention / Treatment: Other: No VR; Device: Oculus Quest 2 VR virtual reality glasses and wired over-ear headphones

• Study Type: Interventional
• Enrollment (Estimated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: burak nalbant; Phone Number: 05332231990; Email: buraknalbant@gmail.com

Study Locations

• Turkey
  • Cankaya
    • Ankara, Cankaya, Turkey
      • Recruiting
      • Ankara City Hospital
      • Contact: burak nalbant; Phone Number: 05332231990; Email: buraknalbant@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• who will undergo upper extremity surgery under regional anesthesia

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standart Anesthesia management; 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; 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.; Other Names: Control group
Experimental: VR group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
State-Trait Anxiety Scale	preoperative and postoperative STAI I and II score questions will be asked.	Preoperative, Postoperative 4.hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
systolic blood pressure	non invasive systolic blood pressure measurement	Preoperative, İntraoperative 0 min, İntraoperative 60min, End of Operation, Postoperative 4.hour
diastolic blood pressure	non invasive diastolic blood pressure measurement	Preoperative, İntraoperative 0 min, İntraoperative 60min, End of Operation, Postoperative 4.hour
mean arterial pressure	mean blood pressure measurement	Preoperative, İntraoperative 0 min, İntraoperative 60min, End of Operation, Postoperative 4.hour
heart rate	intraoperatif and perioperatif ecg monitarization	Preoperative, İntraoperative 0 min, İntraoperative 60min, End of Operation, Postoperative 4.hour
oxygen saturation	intraoperatif and perioperative pulse oxymeter measurement	Preoperative, İntraoperative 0 min, İntraoperative 60min, End of Operation, Postoperative 4.hour
aditional analgesic requirement	postoperative additional analgesic requirement	postoperative up to 24 hour
VAS score	A blinded evaluator will evaluate the visual analog scale score.	Postoperative 1.hour, 4.hour., 12.hour., 24hour.
Patient satisfaction scale	A blinded evaluator will evaluate the Patient satisfaction scale	Postoperative 4.hour
Surgeon satisfaction scale	A blinded evaluator will evaluate the surgeon satisfaction scale	Postoperativ 1.hour
The quality of recovery-15 (QoR-15)	A blinded evaluator will evaluate the QoR-15 scale.	Preoperative, Postoperative 24.hour

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2024
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): July 15, 2024

Study Registration Dates

• First Submitted: January 19, 2024
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Estimated): February 6, 2024

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: E2-23-4787

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No