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

NCT05155826 | Completed

• 2 other identifiers: 21CH027ANSM
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Delivery Problem; Labor Pain

Keywords

labor induction; intra-cervical balloon; pain; virtual reality; Cook®

Outcome Measures

Primary Outcomes (1)

• maximum pain felt during balloon placement

  Measurement of the maximum pain experienced during the placement of the intra-cervical balloon using a numerical scale from 0 to 10: 0 = no pain, 10 = maximum pain.

  Day: 0

Secondary Outcomes (7)

• average pain felt during balloon placement

  Day: 0

• Nociception Level Index (NOL™) during balloon placement

  Day: 0

• Anxiety felt during balloon placement

  Day: 0

• difficulty of balloon placement by the midwife during induction of labor

  Day: 0

• patient's satisfaction with the use of the virtual reality headset.

  Day: 0

Study Arms (2)

standard care (control group)

NO INTERVENTION

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

standard care and virtual reality (experimental group)

EXPERIMENTAL

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

Device: Virtual Reality Headset

Interventions

Virtual Reality Headset 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.

Also known as: Deepsen® VRx and Shenzhen Huajin® electronics Co

standard care and virtual reality (experimental group)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Dystocia; Labor Pain; Pain

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tiphaine RAIA BARJAT, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 14, 2021
• Study Start: February 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: March 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)