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

Primary Purpose

Delivery Problem, Labor Pain

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Virtual Reality Headset
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Delivery Problem focused on measuring labor induction, intra-cervical balloon, pain, virtual reality, Cook®

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • CHU de Saint-Etienne

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

standard care (control group)

standard care and virtual reality (experimental group)

Arm Description

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

Patient benefit the standard care during placement of Cook's balloon (standard care) with the use of a virtual reality.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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)
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.
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
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
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
tolerance of the virtual reality helmet by the patient.
Tolerance is a composite outcome : nausea (YES/NO), dizziness (YES/NO), premature stopping (YES/NO)

Full Information

First Posted
December 1, 2021
Last Updated
March 9, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT05155826
Brief Title
Effect of Virtual Reality for Pain Management During Intracervical Balloon Placement for Artificial Childbirth Induction
Acronym
VIRTUALMAG
Official Title
The Effect of Virtual Reality for Pain Management During Intracervical Balloon Placement for Labor Induction: a Randomized Controlled Trial (VIRTUALMAG)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delivery Problem, Labor Pain
Keywords
labor induction, intra-cervical balloon, pain, virtual reality, Cook®

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard care (control group)
Arm Type
No Intervention
Arm Description
Patient benefit the standard care during the placement of Cook's balloon (standard care).
Arm Title
standard care and virtual reality (experimental group)
Arm Type
Experimental
Arm Description
Patient benefit the standard care during placement of Cook's balloon (standard care) with the use of a virtual reality.
Intervention Type
Device
Intervention Name(s)
Virtual Reality Headset
Other Intervention Name(s)
Deepsen® VRx and Shenzhen Huajin® electronics Co
Intervention Description
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.
Primary Outcome Measure Information:
Title
maximum pain felt during balloon placement
Description
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.
Time Frame
Day: 0
Secondary Outcome Measure Information:
Title
average pain felt during balloon placement
Description
Average pain felt during balloon placement measured by a numerical scale from 0 to 10. (0 no pain - 10 maximum pain).
Time Frame
Day: 0
Title
Nociception Level Index (NOL™) during balloon placement
Description
Measured Nociception Level Index (NOL ™) calculated by the PMD200 Pain Monitor™. Nociception Level Index is numerical index from 0 to 100. (>25 = pain)
Time Frame
Day: 0
Title
Anxiety felt during balloon placement
Description
Anxiety felt during balloon placement measured by a numerical scale from 0 to 10 : 0 = no anxiety - 10 = maximum anxiety.
Time Frame
Day: 0
Title
difficulty of balloon placement by the midwife during induction of labor
Description
Difficulty of balloon placement by the midwife is measured by questionary classified as very easy / easy / ni easy ni difficult / difficult / very difficult
Time Frame
Day: 0
Title
patient's satisfaction with the use of the virtual reality headset.
Description
patient's satisfaction is evaluated by Likert scale: Completely satisfied/ Satisfied/ Neutral/ Not satisfied/ Not at all satisfied
Time Frame
Day: 0
Title
midwife's satisfaction with the use of the virtual reality headset.
Description
midwife's satisfaction is evaluated by Likert scale: Completely satisfied/ Satisfied/ Neutral/ Not satisfied/ Not at all satisfied
Time Frame
Day: 0
Title
tolerance of the virtual reality helmet by the patient.
Description
Tolerance is a composite outcome : nausea (YES/NO), dizziness (YES/NO), premature stopping (YES/NO)
Time Frame
Day: 0

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiphaine RAIA BARJAT, MD
Organizational Affiliation
CHU SAINT ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Saint-Etienne
City
Saint-Étienne
ZIP/Postal Code
42055
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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