Clinical trial NCT06502457: Pain Management With Virtual Reality Hypnosis
Official title: Pain Management With Virtual Reality Hypnosis in Parturients in the Latency or Cervical Ripening Phase
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypnosis
Labor Pain
Virtual Reality
Labor Induction
Latent Period
Keywords: hypnosis
labor pain
virtual reality
labor induction
latent period
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 142
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: pain intensity difference between the first analgesic procedure and 30min later
timeFrame: 30 minutes
Secondary outcomes:
measure: Average consumption of analgesics
timeFrame: 12 hours
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
Study officials:
References: