Clinical trial NCT05155826: Effect of Virtual Reality for Pain Management During Intracervical Balloon Placement for Artificial Childbirth Induction
Official title: The Effect of Virtual Reality for Pain Management During Intracervical Balloon Placement for Labor Induction: a Randomized Controlled Trial (VIRTUALMAG)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delivery Problem
Labor Pain
Keywords: labor induction
intra-cervical balloon
pain
virtual reality
Cook®
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2021-12-14
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective monocentric study, randomized in 2 parallel groups, evaluating the effectiveness of the use of a virtual reality headset on the reduction of pain during intra-cervical balloon insertion for induction versus standard care.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: It's prospective single-center, randomized, single-blind, prospective study (1:1, 2 group randomization) comparing a group of patients who benefited from the use of the virtual reality headset to a group of patients who received standard care during balloon insertion. Two groups of patients will be formed: a "standard care" group and a "standard care + virtual reality" group.

The study will take place at the Saint-Etienne University Hospital Center in the gynecology-obstetrics department.

The principal objective is to evaluate the effectiveness of the use of a virtual reality helmet on the reduction of pain during the insertion of an intra-cervical balloon for childbirth induction versus the use of standard care.

Eligibility criteria: 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

Primary outcomes:
measure: maximum pain felt during balloon placement
timeFrame: Day: 0
Secondary outcomes:
measure: average pain felt during balloon placement
timeFrame: Day: 0
measure: Nociception Level Index (NOL™) during balloon placement
timeFrame: Day: 0
measure: Anxiety felt during balloon placement
timeFrame: Day: 0
measure: difficulty of balloon placement by the midwife during induction of labor
timeFrame: Day: 0
measure: patient's satisfaction with the use of the virtual reality headset.
timeFrame: Day: 0
measure: midwife's satisfaction with the use of the virtual reality headset.
timeFrame: Day: 0
measure: tolerance of the virtual reality helmet by the patient.
timeFrame: Day: 0
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Tiphaine RAIA BARJAT, MD
role: PRINCIPAL_INVESTIGATOR
References: