Clinical trial NCT06244654: Anxiolytic Effectiveness of Virtual Reality Glasses in Surgery
Official title: Anxiolytic Effectiveness of Virtual Reality Glasses in Upper Extremity Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Anxiety
Postoperative Pain
Postoperative Recovery
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: State-Trait Anxiety Scale
timeFrame: Preoperative, Postoperative 4.hour
Secondary outcomes:
measure: systolic blood pressure
timeFrame: Preoperative, İntraoperative 0 min, İntraoperative 60min, End of Operation, Postoperative 4.hour
measure: diastolic blood pressure
timeFrame: Preoperative, İntraoperative 0 min, İntraoperative 60min, End of Operation, Postoperative 4.hour
measure: mean arterial pressure
timeFrame: Preoperative, İntraoperative 0 min, İntraoperative 60min, End of Operation, Postoperative 4.hour
measure: heart rate
timeFrame: Preoperative, İntraoperative 0 min, İntraoperative 60min, End of Operation, Postoperative 4.hour
measure: oxygen saturation
timeFrame: Preoperative, İntraoperative 0 min, İntraoperative 60min, End of Operation, Postoperative 4.hour
measure: aditional analgesic requirement
timeFrame: postoperative up to 24 hour
measure: VAS score
timeFrame: Postoperative 1.hour, 4.hour., 12.hour., 24hour.
measure: Patient satisfaction scale
timeFrame: Postoperative 4.hour
measure: Surgeon satisfaction scale
timeFrame: Postoperativ 1.hour
measure: The quality of recovery-15 (QoR-15)
timeFrame: Preoperative, Postoperative 24.hour
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
state: Cankaya
Study officials:
References:
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.
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.
citation: 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.