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

NCT ID: NCT05155826

Last Updated: 2023-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2023-02-28

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.

Conditions

Delivery Problem; Labor Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

standard care (control group)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

standard care and virtual reality (experimental group)

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

Group Type: EXPERIMENTAL

Virtual Reality Headset

Intervention Type: DEVICE

The patient will benefit from the placement of Cook's balloon (standard care) with the placement of the virtual reality headset on the examination table with the launch of the software before the beginning of the procedure. The virtual reality helmet will be removed at the end of the procedure.

Interventions

Virtual Reality Headset

The patient will benefit from the placement of Cook's balloon (standard care) with the placement of the virtual reality headset on the examination table with the launch of the software before the beginning of the procedure. The virtual reality helmet will be removed at the end of the procedure.

Intervention Type: DEVICE

Other Intervention Names

Deepsen® VRx and Shenzhen Huajin® electronics Co

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tiphaine RAIA BARJAT, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

CHU de Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

ANSM

Identifier Type: OTHER

Identifier Source: secondary_id

21CH027

Identifier Type: -

Identifier Source: org_study_id