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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Recruiting

CT.gov ID

NCT05155826

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Delivery Problem Labor Pain	Device: Virtual Reality Headset	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

The Effect of Virtual Reality for Pain Management During Intracervical Balloon Placement for Labor Induction: a Randomized Controlled Trial (VIRTUALMAG)

Actual Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: standard care (control group) Patient benefit the standard care during the placement of Cook's balloon (standard care).
Experimental: 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.	Device: 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. Other Names: Deepsen® VRx and Shenzhen Huajin® electronics Co

Arm

Intervention/Treatment

No Intervention: standard care (control group)

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

Experimental: 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.

Device: 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.

Other Names:

Deepsen® VRx and Shenzhen Huajin® electronics Co

Outcome Measures

Primary Outcome Measures

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

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).
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)
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
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
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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