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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Preterm Premature Rupture of Membrane

Intervention / Treatment
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* Other: hypnosis
* Other: standart care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hypnosis group<br> | Other: hypnosis<br>* Hypnosis-based intervention with two sessions of hypnosis (focusing on the treatment of anxiety)<br>|
| Active Comparator: Control group<br> | Other: standart care<br>* no intervention no hypnosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State anxiety by STAI-Y-A scale | change in anxiety-status level between baseline and 3-week (+/- 1 week) the STAI-Y-A scale, which is a 20-item self-questionnaire evaluating anxiety at the present time. The measurement is done on a Likert scale from 1 to 4 (each number corresponding to a value, 1 being the lowest and 4 the highest for each item, score ranging from 20 to 80). | between baseline and 3-week (+/- 1 week) prenatal measurement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy related anxiety by PRAQ-R2 | The Pregnancy related Anxiety Questionnaire revised is a 10-item Self-administered questionnaire that assesses specific prenatal anxiety. On a Likert scale ranging from 1 to 5 (each number corresponding to a value, 1 being the lowest and 4 the hghest for each item, score ranging from 10 to 50) | 1 time at baseline | 
| Pregnancy related anxiety by PSAS | The Postnatal Specific Anxiety Scale (PSAS) is a 44-item self-administered questionnaire that assesses specific postpartum anxiety. On a Likert scale ranging from 1 to 4 (each number corresponding to a value, 1 being the lowest and 4 the highest for each item, score ranging from 44 to 176) | 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) | 
| State anxiety by STAI-Y-A | The change in anxiety-status level between the baseline measurement and the postnatal measurements | between the baseline measurement and the postnatal measurements ( at 1 day to 7 days postpartum and at 4 to 6 weeks postpartum) | 
| Perinatal depression by EPDS | the EPDS is a self-administered questionnaire assessing the presence of depressive symptoms in the pre- and postnatal period. This scale has 10 items with a score ranging from 0 to 30, the threshold score is 10.5 | 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) | 
| Childbirth experience by QEVA | The french version of the questionnaire for assessing childbirth experience QACE. this is a 17 item self-questionnaire evaluating the childbirth experience, with a score ranging from 0 to 51, the highest score being the more negative experience. | At 1 day to 7 days postpartum | 
| Labor agentry by LAS ( Labor Agentry Scale) | this is a 32-item self-administered questionnaire evaluating the perceived control during childbirth. the score tanges from 32 to 210, the highest score evaluating a higher perceived control. | at one point at 1day to 7 days postpartum | 
| Perinatal bonding by PAI | the Prenatal Attachement Inventory (PAI) is a 21-item self-administered questionnaire assessing bonding in the prenatal period, on a Likert scale ranging from  almost nerver to almost always, with a total score ranging from 21 to 84, a higher score evaluating a higher bonding | At one point at baseline | 
| postnatal bonding by PPBQ | The Postpartum Bonding Questionnaire (PPBQ) is a 22-item self-administered questionnaire assessing bonding in the postpartum period, on a Likert scale ranging from always to never, with a total score ranging from 0 to 110. A cut-off score of 26 has been indicated as the onset of bonding disorder, and 40 for more severe disorders in bonding with the child | at 4 to 6 weeks postpartum | 
| Pain Visual Analog Scale by EVA | The VAS (Visual Analog Scale) is a self-assessment scale of pain, on a 10cm ruler graduated in mm, ranging from No pain to Maximum pain imaginable. | At 2 time points in the postnatal period : at 1 day to 7 days postpartum and at 4 to 6 weeks postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PPROM, hypnosis, psychology, anxiety, complicated pregnancy