Effects of Immersive Virtual Reality on patient anxiety during surgery : A randomized clinical trial

Phase 3

Conditions: Healthy Subject.

Registration Number: IRCT20230219057451N1

Lead Sponsor: Diponegoro University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 30

Inclusion Criteria

Male and female aged 18-50 years
Graduated from high school/equivalent
American Society of Anesthesiologists (ASA) physical status I-II
Patients who are going to have lower abdominal or lower extremity surgery under regional anesthesia combined with spinal epidural neuraxial block
No previous surgery history
No history of epilepsy, psychiatric disorders, or claustrophobia and having visual acuity > 6/60
Patients with moderate to severe anxiety scores (Spielberger state-trait anxiety inventory [STAI] score > 38)

Exclusion Criteria

Patients with shock or other major anesthetic or surgical complications during the procedure
Patients who refused to participate in the study
Regional anesthetic needle insertion >2 times
VR device (Oculus Quest VR) that is damaged or error during the surgery process
Patients who dropped out of this study

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anxiety score. Timepoint: Before intervention, after intervention, after surgery. Method of measurement: Patient's anxiety measured using Spielberger State-Trait Anxiety Inventory 6 (STAI-6), which is a shortened version of the original STAI (known as the Indonesian version of STAI).

Secondary Outcome Measures

Name	Time	Method
Blood Pressure, Heart Rate, Patient and Surgeon Satisfaction. Timepoint: Blood Pressure and heart rate measured every 10 minutes during the surgical procedure . Patient and Surgeon satisfaction measured after the surgery ended. Method of measurement: Blood pressure measured using automated sphygmomonometer. Heart rate measured using electrocardiograph. Patient and Surgeon satisfaction measured using questionnaire based on likert scale 1 - 10.