Effect of Virtual Reality for Pain Management During Intracervical Balloon Placement for Artifici… (NCT05155826) | Clinical Trial Compass
CompletedNot Applicable
Effect of Virtual Reality for Pain Management During Intracervical Balloon Placement for Artificial Childbirth Induction
France60 participantsStarted 2022-02-01
Plain-language summary
The labor induction concerns 22% of births in France. In the event of labor induction, in almost two thirds of cases, a cervical ripening method is used and the use of mechanical methods is observed for 8% of cervical ripening. Intra-cervical balloon placement is generally well tolerated but is frequently associated with pain and acute anxiety. There are few options for pain relief. Virtual reality, a relatively new intervention, has been studied as a distraction technique for pain relief, but never in the context of the induction of childbirth.
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:
* Any pregnant woman presenting to the Gynecology-Obstetrics Department of the Saint-Etienne University Hospital for an induction by Cook's balloon.
* Patients affiliated or entitled to a social security system
* Patients having given their agreement to participate and after signing the consent form
Exclusion Criteria:
* Woman refusing to participate in the study (lack of consent)
* Non French-speaking woman (impossibility of carrying out a good quality interview of the pregnant woman)
* Women suffering from blindness, deafness or epilepsy against the use of the virtual reality helmet.
* Participation in another interventional study.
* Patient under guardianship or curatorship
* Patient subject to a legal protection measure or unable to express their 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
1
maximum pain felt during balloon placement
Timeframe: Day: 0
Trial details
NCT IDNCT05155826
SponsorCentre Hospitalier Universitaire de Saint Etienne