Anxiolytic Effectiveness of Virtual Reality Glasses in Surgery

Anxiety Clinical Trial

Official title:

Anxiolytic Effectiveness of Virtual Reality Glasses in Upper Extremity Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06244654
• Other study ID #: E2-23-4787
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2024
• Est. completion date: July 15, 2024

Study information

• Verified date: January 2024
• Source: Ankara City Hospital Bilkent
• Contact: burak nalbant
• Phone: 05332231990
• Email: buraknalbant[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: July 15, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Anxiety
• Pain, Postoperative
• Postoperative Pain
• Postoperative Recovery

Intervention

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.

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.

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Ankara	Cankaya

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	State-Trait Anxiety Scale	preoperative and postoperative STAI I and II score questions will be asked.	Preoperative, Postoperative 4.hour
Secondary	systolic blood pressure	non invasive systolic blood pressure measurement	Preoperative, Intraoperative 0 min, Intraoperative 60min, End of Operation, Postoperative 4.hour
Secondary	diastolic blood pressure	non invasive diastolic blood pressure measurement	Preoperative, Intraoperative 0 min, Intraoperative 60min, End of Operation, Postoperative 4.hour
Secondary	mean arterial pressure	mean blood pressure measurement	Preoperative, Intraoperative 0 min, Intraoperative 60min, End of Operation, Postoperative 4.hour
Secondary	heart rate	intraoperatif and perioperatif ecg monitarization	Preoperative, Intraoperative 0 min, Intraoperative 60min, End of Operation, Postoperative 4.hour
Secondary	oxygen saturation	intraoperatif and perioperative pulse oxymeter measurement	Preoperative, Intraoperative 0 min, Intraoperative 60min, End of Operation, Postoperative 4.hour
Secondary	aditional analgesic requirement	postoperative additional analgesic requirement	postoperative up to 24 hour
Secondary	VAS score	A blinded evaluator will evaluate the visual analog scale score.	Postoperative 1.hour, 4.hour., 12.hour., 24hour.
Secondary	Patient satisfaction scale	A blinded evaluator will evaluate the Patient satisfaction scale	Postoperative 4.hour
Secondary	Surgeon satisfaction scale	A blinded evaluator will evaluate the surgeon satisfaction scale	Postoperativ 1.hour
Secondary	The quality of recovery-15 (QoR-15)	A blinded evaluator will evaluate the QoR-15 scale.	Preoperative, Postoperative 24.hour