An interventional study of Virtual Reality Headset in Delivery Problem and Labor Pain, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Supportive care
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.
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.
55 studies on the registry are indexed under Dystocia; 12 are open to participants now.
This study's enrollment of 60 is below the median of 200 across 42 interventional studies indexed under Dystocia.
Browse Dystocia studies →Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 597 studies on the registry; 127 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
Also known as: Deepsen® VRx and Shenzhen Huajin® electronics Co
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.
Time frame: Day: 0
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).
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Day: 0
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2022 to primary completion in Feb 2023, 12 months.
Of 18 interventional studies with no phase under Dystocia, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 40. This study's 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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