Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06502457

Pain Management With Virtual Reality Hypnosis

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Hypnosis Labor Induction Labor Pain Latent Period Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Virtual Reality

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

painkiller

Drug

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

hypnosis group

Other

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.

Primary outcomes

  1. pain intensity difference between the first analgesic procedure and 30min later

    Time frame: 30 minutes

    Assessment of PID (pain intensity difference) between the first analgesic procedure and 30min later.

Secondary outcomes

  1. Average consumption of analgesics

    Time frame: 12 hours

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

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

Acronym: PreVR

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2024
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.