Effectiveness of Virtual Reality-enhanced Interventions on Preoperative Anxiety in Adults Undergoing Elective Surgery (VIPA)

Official Title: Effectiveness of Virtual Reality-enhanced Interventions on Preoperative Anxiety in Adults Undergoing Elective Surgery: A 3-arm Randomised Controlled Trial

Brief Summary: Preoperative anxiety is a common phenomenon in surgical patients, with a pooled global prevalence of 48%. Surgical patients with preoperative anxiety may negatively impact their psychological health and surgical outcomes. Recent studies have revealed the promising effects of virtual reality-enhanced interventions to improve preoperative anxiety symptoms among adults undergoing elective surgery.

There is a lack of interventional studies to compare and evaluate the co-designed preoperative virtual reality-enhanced interventions in adult surgical patients.

This study aims to examine the effects of co-designed virtual reality educational video and virtual reality distraction video on preoperative anxiety symptoms, vital signs, Satisfaction with Life Scale (SWLS), and postoperative anxiety compared to usual care. This study will contribute by evaluating evidence-based, user-centered VIPA that may be effective for improving preoperative anxiety among adult surgical patients.

Study Overview

• Status: Recruiting
• Conditions: Preoperative Anxiety
• Intervention / Treatment: Other: Virtual Reality

• Study Type: Interventional
• Enrollment (Estimated): 270
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sin Lun CHAN; Phone Number: +852-44347185; Email: darrenchan@link.cuhk.edu.hk

Study Locations

• Hong Kong
  • Kowloon, Hong Kong
    • Recruiting
    • Kwong Wah Hospital
    • Contact: Sin Lun CHAN; Phone Number: +852-44347185; Email: darrenchan@link.cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age aged ≥18 years old
• Surgical patients attending Nurse Pre-anaesthetic Assessment Clinic (NPAC)
• American Society of Anesthesiology (ASA) physical status ASA I or ASA II
• Able to communicate in Chinese

Exclusion Criteria:

• Patients who have a cognitive, communication or physical impairment precluding their ability to complete the study
• Patients who are prone to epilepsy or other neurological conditions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Group 1 (Education approach); Participants in Virtual Reality Group 1 (Education approach) will receive a co-designed virtual reality educational 6-minute video via VR headset. The virtual reality educational video includes three main scenes, consisting of preoperative, intraoperative and postoperative content located at operating theatre reception, operating theatre, and post-anaesthetic care unit respectively.	Other: Virtual Reality; The Virtual Reality-enhanced Interventions on Preoperative Anxiety for adults undergoing elective surgery (VIPA) was developed based on theoretical basis, systematic review evidence, and qualitative study.
Experimental: Virtual Reality Group 2 (Distraction approach); Participants in Virtual Reality Group 2 (Distraction approach) will receive a virtual reality distraction 6-minute video via VR headset. The virtual reality distraction video includes immersive natural scenes with concurrent music, without educational component.	Other: Virtual Reality; The Virtual Reality-enhanced Interventions on Preoperative Anxiety for adults undergoing elective surgery (VIPA) was developed based on theoretical basis, systematic review evidence, and qualitative study.
No Intervention: Control Group; Participants in control group will receive usual care only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative anxiety	Preoperative anxiety will be measured using the Short Chinese Version of the State-Trait Anxiety Inventory (Du et al., 2022). Items are rated on a 4-point Likert scale ranging from 1 to 4, with higher scores indicating higher anxiety. The Short Chinese Version of the State-Trait Anxiety Inventory demonstrates good psychometric properties.	Baseline, Immediate post-intervention, Day of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Heart rate will be measured in beats per minute (bpm) using physiological monitors to provide a more objective measurement for anxiety.	Baseline, Immediate post-intervention, Day of surgery
Blood pressure	Blood pressure will be measured in millimeters of mercury (mmHg) using physiological monitors to provide a more objective measurement for anxiety.	Baseline, Immediate post-intervention, Day of surgery
Temperature	Temperature will be measured in degrees Celsius (°C) using tympanic thermometers to provide a more objective measurement for anxiety.	Baseline, Immediate post-intervention, Day of surgery
Life satisfaction	Life satisfaction will be measured using the Chinese version of Satisfaction with Life Scale (SWLS) (Diener et al., 1985). Items are rated on a 7-point Likert scale ranging from 1 to 7, with higher scores indicating higher life satisfaction. The Chinese version of Satisfaction with Life Scale (SWLS) demonstrates good psychometric properties (Wu & Yao, 2006).	Baseline, Immediate post-intervention, Day of surgery, Post-operative day 7
Evaluation of Virtual reality-enhanced interventions questionnaire	Virtual reality-enhanced interventions questionnaire was developed to evaluate virtual reality-enhanced interventions in terms of programme content, content adequacy, content usefulness, willingness to recommend others, satisfaction, and improvement suggestions. The questions are either 4-point Likert scale or open-end questions. The score ranges from 1 to 4, higher scores indicate higher satisfcation and higher agreement.	Immediate post-intervention
Postoperative anxiety	Postoperative anxiety will be measured using the Short Chinese Version of the State-Trait Anxiety Inventory (Du et al., 2022). Items are rated on a 4-point Likert scale ranging from 1 to 4, with higher scores indicating higher anxiety. The Short Chinese Version of the State-Trait Anxiety Inventory demonstrates good psychometric properties.	Post-operative day 7

Collaborators and Investigators

• Sponsor: Sin Lun CHAN

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: January 27, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Virtual Reality; Preoperative Anxiety
• Other Study ID Numbers: CIRB-2025-224-5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No