Preterm Premature Rupture of Membrane
Conditions
Keywords
PPROM, hypnosis, psychology, anxiety, complicated pregnancy
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.
Interventions
OTHERhypnosis
Hypnosis-based intervention with two sessions of hypnosis (focusing on the treatment of anxiety)
OTHERstandart care
no intervention no hypnosis
Sponsors
Laboratory of Psychopathology and Health Processes, University of Paris
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| State anxiety by STAI-Y-A scale | between baseline and 3-week (+/- 1 week) prenatal measurement | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy related anxiety by PSAS | 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) | 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) |
| State anxiety by STAI-Y-A | between the baseline measurement and the postnatal measurements ( at 1 day to 7 days postpartum and at 4 to 6 weeks postpartum) | The change in anxiety-status level between the baseline measurement and the postnatal measurements |
| Perinatal depression by EPDS | 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) | 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 |
| Childbirth experience by QEVA | At 1 day to 7 days postpartum | 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. |
| Pregnancy related anxiety by PRAQ-R2 | 1 time at baseline | 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) |
| Perinatal bonding by PAI | At one point at baseline | 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 |
| postnatal bonding by PPBQ | at 4 to 6 weeks postpartum | 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 |
| Pain Visual Analog Scale by EVA | At 2 time points in the postnatal period : at 1 day to 7 days postpartum and at 4 to 6 weeks postpartum | 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. |
| Labor agentry by LAS ( Labor Agentry Scale) | at one point at 1day to 7 days postpartum | 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. |
Countries
France
Outcome results
None listed