NCT07379450

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress44%
Feb 2026Dec 2026

First Submitted

Initial submission to the registry

January 21, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 27, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

January 21, 2026

Last Update Submit

May 26, 2026

Conditions

Keywords

Preoperative AnxietyVirtual Reality

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Heart rate

    Baseline, Immediate post-intervention, Day of surgery

  • Blood pressure

    Baseline, Immediate post-intervention, Day of surgery

  • Temperature

    Baseline, Immediate post-intervention, Day of surgery

  • Life satisfaction

    Baseline, Immediate post-intervention, Day of surgery, Post-operative day 7

  • Evaluation of Virtual reality-enhanced interventions questionnaire

    Immediate post-intervention

  • +1 more secondary outcomes

Study Arms (3)

Virtual Reality Group 1 (Education approach)

EXPERIMENTAL

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

Virtual Reality Group 2 (Distraction approach)

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Participants in control group will receive usual care only.

Interventions

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.

Virtual Reality Group 1 (Education approach)Virtual Reality Group 2 (Distraction approach)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kwong Wah Hospital

Kowloon, Hong Kong

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 21, 2026

First Posted

January 30, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations