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

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

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.

Study Overview

• Status: Completed
• Conditions: Labor Pain; Delivery Problem
• Intervention / Treatment: Device: Virtual Reality Headset

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tiphaine RAIA BARJAT, MD; Phone Number: +33 (0)477828609; Email: tiphaine.barjat@chu-st-etienne.fr

Study Locations

• France
  • Saint-Étienne, France, 42055
    • CHU DE SAINT-ETIENNE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Tiphaine RAIA BARJAT, MD, CHU Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (Actual): December 14, 2021

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: pain; virtual reality; labor induction; intra-cervical balloon; Cook®
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pregnancy Complications; Obstetric Labor Complications; Labor Pain; Dystocia
• Other Study ID Numbers: 21CH027; ANSM (Other Identifier: 2024-A00286-41)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No