Pain Management With Virtual Reality Hypnosis

NCT ID: NCT06502457

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-09
• Study Completion Date: 2025-08-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

control group

Group Type: ACTIVE_COMPARATOR

painkiller

Intervention Type: DRUG

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

hypnosis group

Group Type: EXPERIMENTAL

hypnosis group

Intervention Type: 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.

Interventions

painkiller

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

Intervention Type: DRUG

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Amiens Picardie

Amiens, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Julien VARGAS, MD

Role: primary

Vargas.julien@chu-amiens.fr

0322088281

Other Identifiers

PI2024_843_0067

Identifier Type: -

Identifier Source: org_study_id