Pain Management With Virtual Reality Hypnosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: painkiller, hypnosis group.
- Who it may be relevant to
- Registry conditions: Hypnosis, Labor Pain, Virtual Reality, Labor Induction. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pain Management With Virtual Reality Hypnosis in Parturients in the Latency or Cervical Ripening Phase
Overview
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
- Drug painkiller
The control group will receive a painkiller adapted to the service protocol after the fetal heart rate has been recorded. - Other hypnosis group
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 i
Primary outcome measures
- pain intensity difference between the first analgesic procedure and 30min later [Time frame: 30 minutes]
Secondary outcome measures (1)
- Average consumption of analgesics [Time frame: 12 hours]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
France · 1 center
- CHU Amiens Picardie — Amiens
Identifiers
NCT: NCT06502457 · PI2024_843_0067