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Completed

NCT Number: NCT05155826

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality Headset

Device

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

Primary outcomes

  1. maximum pain felt during balloon placement

    Time frame: 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 outcomes

  1. average pain felt during balloon placement

    Time frame: Day: 0

    Average pain felt during balloon placement measured by a numerical scale from 0 to 10. (0 no pain - 10 maximum pain).

  2. Nociception Level Index (NOL™) during balloon placement

    Time frame: 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)

  3. Anxiety felt during balloon placement

    Time frame: Day: 0

    Anxiety felt during balloon placement measured by a numerical scale from 0 to 10 : 0 = no anxiety - 10 = maximum anxiety.

  4. difficulty of balloon placement by the midwife during induction of labor

    Time frame: 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

  5. patient's satisfaction with the use of the virtual reality headset.

    Time frame: Day: 0

    patient's satisfaction is evaluated by Likert scale: Completely satisfied/ Satisfied/ Neutral/ Not satisfied/ Not at all satisfied

  6. midwife's satisfaction with the use of the virtual reality headset.

    Time frame: Day: 0

    midwife's satisfaction is evaluated by Likert scale: Completely satisfied/ Satisfied/ Neutral/ Not satisfied/ Not at all satisfied

  7. tolerance of the virtual reality helmet by the patient.

    Time frame: Day: 0

    Tolerance is a composite outcome : nausea (YES/NO), dizziness (YES/NO), premature stopping (YES/NO)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Acronym: VIRTUALMAG

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 14, 2021
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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