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

Labor Pain Clinical Trial

— VIRTUALMAG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05155826
• Other study ID #: 21CH027
• Secondary ID: ANSM
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delivery Problem
• Dystocia
• Labor Pain

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

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