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Clinical Trials/NCT06244654
NCT06244654CompletedNot Applicable

Anxiolytic Effectiveness of Virtual Reality Glasses in Upper Extremity Surgery

Ankara City Hospital Bilkent1 site in 1 country86 target enrollmentStarted: January 25, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
86
Locations
1
Primary Endpoint
State-Trait Anxiety Scale

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • 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

Outcomes

Primary Outcomes

State-Trait Anxiety Scale

Time Frame: Preoperative, Postoperative 4.hour

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

Secondary Outcomes

  • heart rate(Preoperative, İntraoperative 0 min, İntraoperative 60min, End of Operation, Postoperative 4.hour)
  • The quality of recovery-15 (QoR-15)(Preoperative, Postoperative 24.hour)
  • 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)
  • Surgeon satisfaction scale(Postoperativ 1.hour)
  • oxygen saturation(Preoperative, İntraoperative 0 min, İntraoperative 60min, End of Operation, Postoperative 4.hour)
  • aditional analgesic requirement(postoperative up to 24 hour)
  • VAS score(Postoperative 1.hour, 4.hour., 12.hour., 24hour.)
  • Patient satisfaction scale(Postoperative 4.hour)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Burak NALBANT

assistant professor

Ankara City Hospital Bilkent

Study Sites (1)

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