Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000566437
Ethics application status
Approved
Date submitted
29/04/2025
Date registered
3/06/2025
Date last updated
3/06/2025
Date data sharing statement initially provided
3/06/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial to assess the role of a virtual reality device to reduce anxiety in patients undergoing outpatient colposcopy
Scientific title
A randomised controlled trial to assess the role of a virtual reality device to reduce anxiety in patients undergoing outpatient colposcopy
Secondary ID [1] 313812 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anxiety 337262 0
colposcopy 337263 0
Condition category
Condition code
Reproductive Health and Childbirth 333665 333665 0 0
Other reproductive health and childbirth disorders
Mental Health 334022 334022 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of Virtual Reality headset while patient having an outpatient colposcopy. The virtual reality device will only have visual input, no auditory input. It will show a scene of animals (pandas then bears) in a wildlife area. Participants using VR will commence the video immediately prior to the colposcopy while on the colposcopy bed and have it stopped once the colposcopy has completed. We anticipate a standard colposcopy should last no longer than 15 minutes. The VR device will be placed on the patient by one of the study investigators trained on how to start and troubleshoot the VR device. As part of the post procedure survey the colposcopist will document if the VR needed to stop prematurely for any reason (eg side effects, patient request or technical difficulties)
Intervention code [1] 330923 0
Treatment: Devices
Comparator / control treatment
The control group will have an outpatient colposcopy without use of the virtual reality headset but will have access to watching the colposcopy monitor which is part of the standard procedure. We anticipate a standard colpsocopy should not last more than 15 minutes. The colposcopy will be performed by a doctor or trained gynaecology-oncology clinical nurse coordinator
Control group
Active

Outcomes
Primary outcome [1] 341255 0
Anxiety
Timepoint [1] 341255 0
At the end of colposcopy.
Primary outcome [2] 341256 0
Pain
Timepoint [2] 341256 0
At the end of the colposcopy using a post-colposcopy questionnaire
Secondary outcome [1] 446920 0
Adverse side effects. Possible side effects include vertigo, nausea, dizziness.
Timepoint [1] 446920 0
Asked via questionnaire immediately post colposcopy once they had come off the bed and were dressed.

Eligibility
Key inclusion criteria
18 years of age or older, required a colposcopy and possible minor cervical procedures as an outpatient and never had a colposcopy previously
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnant, on psychotropic medications, had uncorrected visual impairment, history of seizures or severe motion sickness or unable to understand written and spoken English

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer software
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
There have been no previous randomized controlled trials studying the use of VR to decrease anxiety in colposcopy. As such no details exist on what is determined to be the minimal measurable difference in anxiety score between the two groups to be considered statistically significant. The closest study in the literature which used an intervention during colposcopy and the STAI questionnaire as an assessment tool for anxiety was a study using music during colposcopy. The authors found a lower state anxiety score post colposcopy in patients who had colposcopy with music compared to no music (mean difference in anxiety scores -4.8+/- 12.3SD). As per this study 104 patients were required in each arm and was the basis for our power calculation.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Slow recruitment due to COVID-19 and also no clinical difference in scores seen with interim analysis
Date of first participant enrolment
Anticipated
Actual
3/02/2020
Date of last participant enrolment
Anticipated
Actual
8/12/2021
Date of last data collection
Anticipated
Actual
8/12/2021
Sample size
Target
200
Accrual to date
Final
124
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 318281 0
Charities/Societies/Foundations
Name [1] 318281 0
Australian Society for Colposcopy and Cervical Pathology
Country [1] 318281 0
Australia
Funding source category [2] 318836 0
Hospital
Name [2] 318836 0
Chris O'Brien Lifehouse Research Fund
Country [2] 318836 0
Australia
Primary sponsor type
Individual
Name
A/Prof Selvan Pather - Chris O'Brien Lifehouse
Address
Country
Australia
Secondary sponsor category [1] 320665 0
Hospital
Name [1] 320665 0
Chris O'Brien Lifehouse
Address [1] 320665 0
Country [1] 320665 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316922 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 316922 0
Ethics committee country [1] 316922 0
Australia
Date submitted for ethics approval [1] 316922 0
Approval date [1] 316922 0
07/08/2019
Ethics approval number [1] 316922 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139434 0
A/Prof Selvan Pather
Address 139434 0
Chris O'Brien Lifehouse, Missenden Road, Camperdown, NSW 2050
Country 139434 0
Australia
Phone 139434 0
+61 285140257
Fax 139434 0
Email 139434 0
[email protected]
Contact person for public queries
Name 139435 0
Selvan Pather
Address 139435 0
Chris O'Brien Lifehouse, Missenden Road, Camperdown, NSW 2050
Country 139435 0
Australia
Phone 139435 0
+61 285140257
Fax 139435 0
Email 139435 0
[email protected]
Contact person for scientific queries
Name 139436 0
Selvan Pather
Address 139436 0
Chris O'Brien Lifehouse, Missenden Road, Camperdown, NSW 2050
Country 139436 0
Australia
Phone 139436 0
+61 285140257
Fax 139436 0
Email 139436 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.