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Pain Management With Virtual Reality Hypnosis (PreVR)

C

Centre Hospitalier Universitaire, Amiens

Status

Enrolling

Conditions

Labor Pain
Hypnosis
Labor Induction
Latent Period
Virtual Reality

Treatments

Drug: painkiller
Other: hypnosis group

Study type

Interventional

Funder types

Other

Identifiers

NCT06502457
PI2024_843_0067

Details and patient eligibility

About

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.

Enrollment

142 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

142 participants in 2 patient groups

control group
Active Comparator group
Treatment:
Drug: painkiller
hypnosis group
Experimental group
Treatment:
Other: hypnosis group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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