CompletedNot Applicable

Virtual Reality and Outpatient Hysteroscopy

United Kingdom40 participantsStarted 2018-08-04

Plain-language summary

TITLE Virtual Reality (VR) as a Distraction technique for management of acute pain at Outpatient Hysteroscopy DESIGN Randomised Control Trial (RCT) with Mixed methods - Qualitative and quantitative AIMS To study the role of distraction techniques for management of acute pain in Outpatient Hysteroscopy and to assess feasibility of using Virtual Reality for managing pain. Primary objective: • Feasibility of using virtual reality as a distraction technique in management of acute pain in patients undergoing Outpatient Hysteroscopy. Secondary objectives: * Understanding the acceptability and effectiveness of VR interventions within the procedural groups and how these might vary as a function of different patient demographics. * Understanding the factors that might influence the willingness of patients to participate in a future formal trial of the technology. * Understanding how best to implement the technology and designing of the contents of the VR intervention. * Understanding the effective mechanisms for the analgesic effect of VR and explore how this could be tailored to individual patients. POPULATION Patients attending the Outpatient Hysteroscopy clinics ELIGIBILITY Patients undergoing Outpatient Hysteroscopy DURATION 6 months

Who can participate

Age range

18 Years – 70 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: Inclusion criteria will include all women of at least 18 - 70 years of age, planned for an office hysteroscopy. Staff: Inclusion criteria will include the clinician performing the outpatient hysteroscopy and the nurse supporting the clinic. Exclusion Criteria: Patients: * Hearing impairments and blindness * Any known anatomical characteristics that may make performing the office procedure more difficult (e.g., cervical conization, Manchester Fothergill). * The denial or withdrawal of oral informed consent Staff: The denial or withdrawal of informed consent

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

Worst Pain Scores

Timeframe: during the hysteroscopy procedure, an average of 10 minutes

Average Pain Scores

Timeframe: 10 minutes immediately before and after the procedure

Anxiety Scores

Timeframe: during the hysteroscopy procedure, an average of 10 minutes

Trial details

NCT IDNCT03699280

SponsorImperial College London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-10-06

Results submitted2021-11-12

View on ClinicalTrials.gov More Acute Pain trials