Anxiolytic Effectiveness of Virtual Reality Glasses in Surgery

Not Applicable

Completed

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

• Registration Number: NCT06244654
• Lead Sponsor: Ankara City Hospital Bilkent

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-19
• Study Start: 2024-01-25
• Study First Submitted QC: 2024-01-29
• Study First Posted: 2024-02-06
• Primary Completion: 2024-06-30
• Study Completion: 2024-07-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VR group	Oculus Quest 2 VR virtual reality glasses and wired over-ear headphones	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.
Standart Anesthesia management	No VR	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.

Primary Outcome Measures

Name	Time	Method
State-Trait Anxiety Scale	Preoperative, Postoperative 4.hour	preoperative and postoperative STAI I and II score questions will be asked.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ankara City Hospital; 🇹🇷 Ankara, Cankaya, Turkey