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Pain Management With Virtual Reality Hypnosis

Pain Management With Virtual Reality Hypnosis in Parturients in the Latency or Cervical Ripening Phase

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06502457
Acronym
PreVR
Enrollment
142
Registered
2024-07-16
Start date
2024-07-09
Completion date
2025-08-31
Last updated
2025-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypnosis, Labor Pain, Virtual Reality, Labor Induction, Latent Period

Keywords

hypnosis, labor pain, virtual reality, labor induction, latent period

Brief summary

The latency phase corresponds to the first phase of the first stage of labour, during which the parturient feels regular, rhythmic uterine contractions that are often painful, with or without changes of the cervix. This phase lasts an average of 8 hours for primiparous women, compared with 5 hours for multiparous women, and can last up to twenty hours in total. Cervical ripening corresponds to the medical induction of regular, painful uterine contractions in order to obtain a favourable cervix for the induction of labour. Cervical ripening is carried out either medically (oral or local prostaglandins) or mechanically (double balloon dilatation) and accounts for 69.2% of labour inductions, which in turn account for 25.8% of births. At Amiens-Picardie University Hospital, this maturation stage can last from a few hours to 2 days, depending on the service protocol. What these two stages of childbirth have in common is that they are both painful, with very few analgesic drugs available that can be used without side-effects on the foetus during pregnancy. In recent years, there has also been a growing demand from parturients for the use of non-medicinal therapies. It therefore seems essential to provide parturients with as many effective non-drug methods as possible to manage their pain properly. If virtual reality hypnosis sessions prove to be effective, they will provide better pain management for women in labour, reduce the use of morphine derivatives (with their attendant side-effects, particularly on the foetus), and above all meet the growing demand from women in labour for the most physiological possible support during childbirth.

Interventions

The control group will receive a painkiller adapted to the service protocol after the fetal heart rate has been recorded.

The hypnosis group will receive a hypnosis session after the fetal heart rate has been recorded. Automated measurement of blood pressure and maternal heart rate will take place during the session in order to objectively assess the impact of the session on the mother. Patients in the hypnosis group will then have access to the virtual reality headset on request throughout the latency or maturation phase, and will also be able to benefit from a painkiller in accordance with the service protocol if they so request.

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Parturient over 18 * Parturient who speaks and understands French * Parturient hospitalised prior to labour * Membranes intact or ruptured * Spontaneous or induced labour * Parturient in latency phase * Term ≥ 37SA * END \> 3 * Parturient requiring active pain management (medicinal or non-medicinal) * Low-risk pregnancy

Exclusion criteria

* Parturient under legal protection * Parturient with a hearing impairment * Parturient with visual impairment * Parturient with epilepsy * Parturient with psychiatric problems * Pathological pregnancy * Parturient with chronic pain * Parturient with addiction-related disorders * Parturient allergic to paracetamol * Parturient allergic to phloroglucinol * Parturient allergic to codeine * Parturient allergic to nalbuphine * Parturient allergic to orozamudol

Design outcomes

Primary

MeasureTime frameDescription
pain intensity difference between the first analgesic procedure and 30min later30 minutesAssessment of PID (pain intensity difference) between the first analgesic procedure and 30min later.

Secondary

MeasureTime frameDescription
Average consumption of analgesics12 hoursAverage consumption of analgesics (morphine agonists and other analgesics) during the latency or maturation period.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026