Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06393556




Registration number
NCT06393556
Ethics application status
Date submitted
26/04/2024
Date registered
1/05/2024
Date last updated
31/05/2024

Titles & IDs
Public title
VR for the Reduction of Perioperative Anxiety
Scientific title
Assessment and Minimization of Preoperative Fear of the Unknown Using a VR Experience of the Theatre Suite; a Randomized Control Trial
Secondary ID [1] 0 0
VRPERIOP1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety State 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Virtual reality experience

Experimental: Virtual reality - Care-as-usual + virtual reality intervention during a pre-operative visit

No Intervention: Control - Care-as-usual during a pre-operative visit


Other interventions: Virtual reality experience
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Anxiety
Timepoint [1] 0 0
T0 (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)

Eligibility
Key inclusion criteria
- Gynecological oncology patients with scheduled surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Language barrier

- Inability to provide consent

- Having undergone any procedure at the operating theatre in the previous 5 years

Study design
Purpose of the study
Supportive Care
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/05/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/02/2022
Sample size
Target
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 0 0
4215 - Southport

Funding & Sponsors
Primary sponsor type
Other
Name
Ruhr University of Bochum
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Gold Coast Hospital and Health Service
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06393556
Trial related presentations / publications
Cao X, Yumul R, Elvir Lazo OL, Friedman J, Durra O, Zhang X, White PF. A novel visual facial anxiety scale for assessing preoperative anxiety. PLoS One. 2017 Feb 14;12(2):e0171233. doi: 10.1371/journal.pone.0171233. eCollection 2017.
Public notes

Contacts
Principal investigator
Name 0 0
Bernd C Schmid, MD
Address 0 0
Gold Coast University Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06393556