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A randomised controlled trial to assess the role of a virtual reality device to reduce anxiety in patients undergoing outpatient colposcopy

A randomised controlled trial to assess the role of a virtual reality device to reduce anxiety in patients undergoing outpatient colposcopy

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000566437
Enrollment
124
Registered
2025-06-03
Start date
2020-02-03
Completion date
2021-12-08
Last updated
2025-09-08

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

Conditions

None listed

Brief summary

This study compares the effectiveness of using virtual reality during outpatient colposcopy in decreasing anxiety in pain compared to colposcopy without it. Willing patients will be randomly allocated to either arm and asked to complete a pre and post procedure questionnaire on the day of colposcopy to assess their pain and anxiety scores. Our hypothesis is that virtual reality by creating an immersive experience can distract patients during colposcopy and decrease their pain and anxiety. 200 patients are required to show such a difference, 100 patients in each arm.

Interventions

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

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)

Sponsors

A/Prof Selvan Pather - Chris O'Brien Lifehouse
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026