Pain Management With Virtual Reality Hypnosis (PreVR)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Labor Pain; Hypnosis; Virtual Reality; Labor Induction; Latent Period
• Intervention / Treatment: Drug: painkiller; Other: hypnosis group

• Study Type: Interventional
• Enrollment (Estimated): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France
    • Recruiting
    • CHU Amiens Picardie
    • Contact: Julien VARGAS, MD; Phone Number: 0322088281; Email: Vargas.julien@chu-amiens.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group	Drug: painkiller; The control group will receive a painkiller adapted to the service protocol after the fetal heart rate has been recorded.
Experimental: hypnosis group	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 if they so request.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain intensity difference between the first analgesic procedure and 30min later	Assessment of PID (pain intensity difference) between the first analgesic procedure and 30min later.	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average consumption of analgesics	Average consumption of analgesics (morphine agonists and other analgesics) during the latency or maturation period.	12 hours

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: July 9, 2024
• First Submitted That Met QC Criteria: July 9, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 25, 2025
• Last Update Submitted That Met QC Criteria: May 21, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: virtual reality; hypnosis; labor pain; labor induction; latent period
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics
• Other Study ID Numbers: PI2024_843_0067

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No