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

Study Overview
=================
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.

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

Conditions
-----------------
Delivery Problem, Labor Pain

Intervention / Treatment
-----------------
* Device: Virtual Reality Headset


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: standard care (control group)<br>Patient benefit the standard care during the placement of Cook's balloon (standard care). | |
| Experimental: standard care and virtual reality (experimental group)<br>Patient benefit the standard care during placement of Cook's balloon (standard care) with the use of a virtual reality. | Device: Virtual Reality Headset<br>* 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.<br>* Other names: Deepsen® VRx and Shenzhen Huajin® electronics Co;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
labor induction, intra-cervical balloon, pain, virtual reality, Cook®