Delivery ProblemVIRTUALMAGNCT05155826
Effect of Virtual Reality for Pain Management During Intracervical Balloon Placement for Artificial Childbirth Induction
A study testing Virtual Reality Headset in people with Delivery Problem and Labor Pain, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Delivery Problem, Labor Pain
- What is being tested?
- Virtual Reality Headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2022to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Delivery Problem, Labor Pain
- Being tested
- Virtual Reality Headset
- Keywords
- labor induction, intra-cervical balloon, pain, virtual reality, Cook®
- Medical subject headings
- Dystocia, Labor Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality HeadsetDevice
Also called Deepsen® VRx and Shenzhen Huajin® electronics Co
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.
| Study group | Role | What they receive |
|---|---|---|
| standard care (control group) | No intervention | Patient benefit the standard care during the placement of Cook's balloon (standard care). |
| standard care and virtual reality (experimental group) | Experimental | Patient benefit the standard care during placement of Cook's balloon (standard care) with the use of a virtual reality. Receives: Device: Virtual Reality Headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day: 0
Secondary outcomes (7)
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).
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: Day: 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start1 Feb 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delivery ProblemStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tiphaine RAIA BARJAT, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155826
- Sponsor's protocol ID
- 21CH027
- Other IDs
- ANSM
- Acronym
- VIRTUALMAG
- Status last verified
- Jun 2026
- First submitted
- 1 Dec 2021
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality for Pain Management During Intracervical Balloon Placement for Labor Induction: a Randomized Controlled Trial (VIRTUALMAG)
- ClinicalTrials.gov ID
- NCT05155826
- Acronym / sponsor ID
- VIRTUALMAG / 21CH027
- Conditions
- Delivery Problem, Labor Pain
- Keywords
- labor induction, intra-cervical balloon, pain, virtual reality, Cook®
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 14 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| standard care (control group) | No intervention | –Patient benefit the standard care during the placement of Cook's balloon (standard care). |
| standard care and virtual reality (experimental group) | Experimental | Device: Virtual Reality HeadsetPatient benefit the standard care during placement of Cook's balloon (standard care) with the use of a virtual reality. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality HeadsetAlso: Deepsen® VRx and Shenzhen Huajin® electronics CoThe 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. | Device | standard care and virtual reality (experimental group) |
Primary outcome
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.
7 secondary outcomes
average pain felt during balloon placement
Time frame: Day: 0
Nociception Level Index (NOL™) during balloon placement
Time frame: Day: 0
Anxiety felt during balloon placement
Time frame: Day: 0
difficulty of balloon placement by the midwife during induction of labor
Time frame: Day: 0
patient's satisfaction with the use of the virtual reality headset.
Time frame: Day: 0
midwife's satisfaction with the use of the virtual reality headset.
Time frame: Day: 0
tolerance of the virtual reality helmet by the patient.
Time frame: Day: 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
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Calcium Carbonate on Labor Induction
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Oral Sodium Bicarbonate for the Prevention of Labour Dystocia
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Maternal Maneuvers During Prolonged Labor
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiphaine RAIA BARJAT, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Headset in people with Delivery Problem and Labor Pain, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum pain felt during balloon placement (time frame: Day: 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.