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

Not Applicable

Completed

• Conditions: Labor Pain; Delivery Problem
• Interventions: Device: Virtual Reality Headset

• Registration Number: NCT05155826
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Timeline

• Study First Submitted: 2021-12-01
• Study First Submitted QC: 2021-12-01
• Study First Posted: 2021-12-14
• Study Start: 2022-02-01
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-09
• Last Update Posted: 2023-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard care and virtual reality (experimental group)	Virtual Reality Headset	Patient benefit the standard care during placement of Cook's balloon (standard care) with the use of a virtual reality.

Primary Outcome Measures

Name	Time	Method
maximum pain felt during balloon placement	Day: 0	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.

Secondary Outcome Measures

Name	Time	Method
Nociception Level Index (NOL™) during balloon placement	Day: 0	Measured Nociception Level Index (NOL ™) calculated by the PMD200 Pain Monitor™.; Nociception Level Index is numerical index from 0 to 100. (\>25 = pain)
patient's satisfaction with the use of the virtual reality headset.	Day: 0	patient's satisfaction is evaluated by Likert scale: Completely satisfied/ Satisfied/ Neutral/ Not satisfied/ Not at all satisfied
Anxiety felt during balloon placement	Day: 0	Anxiety felt during balloon placement measured by a numerical scale from 0 to 10 : 0 = no anxiety - 10 = maximum anxiety.
difficulty of balloon placement by the midwife during induction of labor	Day: 0	Difficulty of balloon placement by the midwife is measured by questionary classified as very easy / easy / ni easy ni difficult / difficult / very difficult
average pain felt during balloon placement	Day: 0	Average pain felt during balloon placement measured by a numerical scale from 0 to 10. (0 no pain - 10 maximum pain).
midwife's satisfaction with the use of the virtual reality headset.	Day: 0	midwife's satisfaction is evaluated by Likert scale: Completely satisfied/ Satisfied/ Neutral/ Not satisfied/ Not at all satisfied
tolerance of the virtual reality helmet by the patient.	Day: 0	Tolerance is a composite outcome : nausea (YES/NO), dizziness (YES/NO), premature stopping (YES/NO)

Trial Locations

Locations (1)

CHU de Saint-Etienne; 🇫🇷 Saint-Étienne, France