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 range18 Years

SexFEMALE

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

What they're measuring

maximum pain felt during balloon placement

Timeframe: Day: 0

Trial details

NCT IDNCT05155826

SponsorCentre Hospitalier Universitaire de Saint Etienne

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-28