CompletedNot Applicable

Mind Over Cervix: Using Virtual Reality to Reduce Colposcopy Anxiety

United Kingdom141 participantsStarted 2024-05-22

Plain-language summary

Colposcopy is an extremely important part of womens healthcare in the prevention of cervical cancer. Women report feeling extremely anxious attending colposcopy, due to the association with cancer and the intimate nature of the examination. The goal of this clinical trial is to investigate where the use of virtual reality headsets during outpatient colposcopy appointments has any effect on womens' experience. The main question\[s\] it aims to answer are: * Does the use of virtual reality headsets reduce anxiety in patients attending colposcopy * Does the use of virtual reality headsets reduce pain in patients attending colposcopy Patients will offered to enroll in the trial when they attend for their colposcopy appointment. Participants will fill out a questionnaire to measure their anxiety beforehand and collect patient demographics. They will be randomly allocated into the intervention arm or the control arm. This means they will either use virtual reality headset in addition to the standard care, or have standard colposcopy care only After their colposcopy, they will then be asked to to fill out another questionnaire to measure anxiety and pain levels. If there is a comparison group: Researchers will compare the results from the women who had colposcopy while using the virtual reality headsets to women to see if there is any meaningful difference in anxiety while using the virtual reality headsets.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients * women over 18 years of age who attend for outpatient colposcopy and provide informed written consent * Staff * Have completed colposcopy training and be a registered member of the British Society of Colposcopy and Cervical Pathology (BSCCP) * Informed written consent to take part in the trial. Exclusion Criteria: * Patients : * Significant hearing or visual impairments that may effect communication * Any known characteristics that may make the office procedure more difficult (eg. previous LLETZ, previous cervical conisation, uterine didelphis) * Inability to provide consent. * Denial or withdrawal of informed consent orally Staff : * The denial or withdrawal of informed consent. * Trainee colposcopist performing clinic.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Anxiety level

Timeframe: Before colposcopy and within 15 minutes after the procedure

Trial details

NCT IDNCT06693583

SponsorUniversity of Ulster

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-09

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