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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230219057451N1

Enrollment

Registered

2023-02-21

Start date

2021-10-14

Completion date

Unknown

Last updated

2023-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subject.

Interventions

Intervention 1: Intervention group:. Intervention 2: Control group:.

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Indonesia

Contacts

Public ContactTaufan Pramadika

Diponegoro University

taufanpramadika@ymail.com+62 622 47611196

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026