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RecruitingNCT06502457PreVRUpdated May 25, 2025

Pain Management With Virtual Reality Hypnosis

An interventional study of painkiller and hypnosis group in Hypnosis, Labor Pain and Virtual Reality, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-25.

Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Jul 2024; still recruiting 2 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
142
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Hypnosis
  • Labor Pain
  • Virtual Reality
  • Labor Induction
  • Latent Period

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Keywords

  • hypnosis
  • labor pain
  • virtual reality
  • labor induction
  • latent period
03

In context

Labor Pain

396 studies on the registry are indexed under Labor Pain; 66 are open to participants now.

This study's planned enrollment of 142 is above the median of 100 across 326 interventional studies indexed under Labor Pain.

Browse Labor Pain studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
142 participants (estimated)

Study arms

  • Active comparator
    control group

    Drug: painkiller

  • Experimental
    hypnosis group

    Other: hypnosis group

Interventions

  • Drugpainkiller

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

  • Otherhypnosis 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 minutes

Secondary outcomes

  1. Average consumption of analgesics

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

    Time frame: 12 hours

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06502457
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Responsible party
Sponsor
First posted
Jul 16, 2024
Start date
Jul 9, 2024
Primary completion
Jul 2025 (estimated)
Completion
Aug 2025 (estimated)
Last update
May 25, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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