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VR for the Reduction of Perioperative Anxiety

Assessment and Minimization of Preoperative Fear of the Unknown Using a VR Experience of the Theatre Suite; a Randomized Control Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06393556
Enrollment
80
Registered
2024-05-01
Start date
2019-05-10
Completion date
2022-02-04
Last updated
2024-05-31

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

Conditions

Anxiety State

Keywords

anxiety, virtual reality, gynecologic-oncological surgery

Brief summary

The study, set to take place at Gold Coast University Hospital in Australia, will be conducted as a randomized controlled trial. Patients preparing for gynecological cancer surgery will be recruited and randomly assigned to one of two groups: those who will receive standard care plus a virtual reality (VR) intervention, and those who will receive only standard care. Standard care encompasses the usual pre-operative procedures and support provided by the hospital staff. We hypothesize that immersing patients in a preparatory virtual environment that shows them what they are to expect during their upcoming hospital stay for surgery, could help reduce their anxiety levels.

Detailed description

The study objective is to determine whether exposure to the operating theatre suite via virtual reality (VR) for patients undergoing gynecologic-oncological surgery reduces pre-operative anxiety. After patients are recruited, their anxiety level is measured by a simple 6-item visual anxiety scale (T0). Patients are then randomized into either receiving care-as-usual (CAU), or CAU combined with a VR experience (\ 3.5 minutes; with background music and narration) where they are familiarized with the environment they will encounter during their stay for their cancer operation. Anxiety is measured again (T1). Days/weeks later, when patients are back in the hospital for their surgery (T2), anxiety is measured again in the preanesthetic bay, before receiving any anesthetics. Personnel collecting the anxiety scale at T2 will be unaware whether a patient had received the VR intervention or not. Randomization will be performed by a person unrelated to the study by using a computerized randomization tool to generate an allocation list and inserting paper slips with the group allocation into consecutively numbered, opaque envelopes which are opened, in order, at the time of randomization. Using a two-sided Wilcoxon-Mann-Whitney test and targeting a power of 80% at a significance level α of 0.05, abd assuming a clinically relevant difference in the anxiety scale of at least one face (i.e. at least 1 point on the 6-item scale) between the two groups and a within-group standard deviation of 1.6 (effect size: 0.625), sample size was determined as 34 patients per group for a 1:1 group allocation. Assuming a drop out/lost-to-follow up rate of up to 15%, 80 patients (40 per group) are to be recruited. Descriptive statistic analysis will be performed. Within-group and between-group assessements will be done using Wilcoxon signed rank test and the Mann-Whitney rank sum test, respectively.

Interventions

An immersive VR experience, delivered using a VR head-mounted display, of the real-world environment at the hospital, featuring the pre-operative admission suite, pre-anesthetic bay, operating theatre, postoperative recovery room, and medical staff.

Sponsors

Gold Coast Hospital and Health Service
CollaboratorOTHER_GOV
Ruhr University of Bochum
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Masking description

Care provider measuring the primary outcome scale at T2 was not aware of the intervention given at T0/1. Statistical data analysis initially was prepared not knowing which group was the intervention group.

Intervention model description

1:1 randomization

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Gynecological oncology patients with scheduled surgery

Exclusion criteria

* Language barrier * Inability to provide consent * Having undergone any procedure at the operating theatre in the previous 5 years

Design outcomes

Primary

MeasureTime frameDescription
AnxietyT0 (before randomization), T1 (same day as T0, but after care as usual +/- VR; usually inside 1 hour), T2 (days/weeks later, before surgical procedure - exact gap is unknown; expected: >3 days, median around 4-7 weeks)Anxiety level measured by a 6-item visual scale (1 .. least anxiety, 6 ... highest anxiety)

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026