Pain Management With Virtual Reality Hypnosis

Not Applicable

Recruiting

• Conditions: Hypnosis; Labor Pain; Virtual Reality; Labor Induction; Latent Period
• Interventions: Drug: painkiller; Other: hypnosis group

• Registration Number: NCT06502457
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-09
• Study First Submitted: 2024-07-09
• Study First Submitted QC: 2024-07-09
• Study First Posted: 2024-07-16
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-25
• Primary Completion: 2025-07
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 142

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	painkiller	-
hypnosis group	hypnosis group	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Average consumption of analgesics	12 hours	Average consumption of analgesics (morphine agonists and other analgesics) during the latency or maturation period.

Trial Locations

Locations (1)

CHU Amiens Picardie; 🇫🇷 Amiens, France