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The Psychological Experience of Pathological Pregnancy. Study of the Case of Premature Rupture of Membranes and Evaluation of the Impact of Hypnosis Support (HYPNOPROM)

U

University Hospital, Lille

Status

Enrolling

Conditions

Preterm Premature Rupture of Membrane

Treatments

Other: hypnosis
Other: standart care

Study type

Interventional

Funder types

Other

Identifiers

NCT05353153
2021-A02139-32 (Other Identifier)
2021_0409

Details and patient eligibility

About

This research investigates the impact of a hypnosis-based intervention in alleviating state anxiety in Preterm Premature Rupture of Membranes (PPROM). Our main hypothesis is that a two-session intervention can decrease anxiety for pregnant women with PPROM compared to usual care. This research also studies the impact of the experience of a PPROM during a pregnancy on several variables such as perinatal depression, pregnancy-related anxiety, bonding and childbirth experience, as well as control and pain perceived during chilbirth. Our hypotheses are that the experience of PPROM negatively influences these variables, and that this impact is alleviated by the hypnosis-based intervention for the experimental group.

Enrollment

94 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Being an adult French-speaking woman,
  • primi or multipara,
  • less than 33 weeks and 6 days of amenorrhea
  • having being diagnosed with PPROM

Exclusion criteria

  • Women cognitively impaired or with important hearing issues,
  • being placed under protective measures,
  • caring more than one fetus,
  • having a severe, preexisting or triggered during the pregnancy,
  • psychiatric pathology,
  • caring a fetus with an abnormality having required further medical investigations, or participating in another clinical trial comprising an intervention measuring psychological variables

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

94 participants in 2 patient groups

hypnosis group
Experimental group
Treatment:
Other: hypnosis
Control group
Active Comparator group
Treatment:
Other: standart care

Trial contacts and locations

1

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Central trial contact

Sara BALAGNY, MD

Data sourced from clinicaltrials.gov

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