Clinical trial NCT05353153: The Psychological Experience of Pathological Pregnancy. Study of the Case of Premature Rupture of Membranes and Evaluation of the Impact of Hypnosis Support
Official title: The Psychological Experience of Pathological Pregnancy. Study of the Case of Premature Rupture of Membranes and Evaluation of the Impact of Hypnosis Support
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm Premature Rupture of Membrane
Keywords: PPROM
hypnosis
psychology
anxiety
complicated pregnancy
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Laboratory of Psychopathology and Health Processes, University of Paris
First posted: 2022-04-29
Enrollment: 94
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: State anxiety by STAI-Y-A scale
timeFrame: between baseline and 3-week (+/- 1 week) prenatal measurement
Secondary outcomes:
measure: Pregnancy related anxiety by PRAQ-R2
timeFrame: 1 time at baseline
measure: Pregnancy related anxiety by PSAS
timeFrame: At 4 time points: 2 in the prenatal period (at baseline and 3 weeks after) and 2 in the postnatal period (at 1 day to 7 days postpartum and at 4 to 6 weeks postpartum)
measure: State anxiety by STAI-Y-A
timeFrame: between the baseline measurement and the postnatal measurements ( at 1 day to 7 days postpartum and at 4 to 6 weeks postpartum)
measure: Perinatal depression by EPDS
timeFrame: At 3 time points: 2 in the prenatal period (at baseline and 3 weeks after) and 1 in the postnatal period ( at 4 to 6 weeks postpartum)
measure: Childbirth experience by QEVA
timeFrame: At 1 day to 7 days postpartum
measure: Labor agentry by LAS ( Labor Agentry Scale)
timeFrame: at one point at 1day to 7 days postpartum
measure: Perinatal bonding by PAI
timeFrame: At one point at baseline
measure: postnatal bonding by PPBQ
timeFrame: at 4 to 6 weeks postpartum
measure: Pain Visual Analog Scale by EVA
timeFrame: At 2 time points in the postnatal period : at 1 day to 7 days postpartum and at 4 to 6 weeks postpartum
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez, Had, Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Sara BALAGNY, MD
role: PRINCIPAL_INVESTIGATOR
References: