Pain Management With Virtual Reality Hypnosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Parturient over 18

Parturient who speaks and understands French

Parturient hospitalised prior to labour

Membranes intact or ruptured

Disqualifiers

Parturient under legal protection

Parturient with a hearing impairment

Parturient with visual impairment

Parturient with epilepsy

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

142 Participants
are divided into 2 treatment groups
Group A: control groupActive comparator 1 intervention
Group B: hypnosis groupExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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