Effect of Virtual Reality for Pain Management During Intracervical Balloon Placement for Artificial Childbirth Induction (VIRTUALMAG)

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Labor Pain; Delivery Problem

Treatments: Device: Virtual Reality Headset

Study type: Interventional

Funder types: Other

Identifiers

NCT05155826

21CH027

ANSM (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

standard care (control group)

No Intervention group

Description:

Patient benefit the standard care during the placement of Cook's balloon (standard care).

standard care and virtual reality (experimental group)

Experimental group

Description:

Patient benefit the standard care during placement of Cook's balloon (standard care) with the use of a virtual reality.

Treatment:

Device: Virtual Reality Headset