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

Preterm Premature Rupture of Membrane Clinical Trial

— HYPNOPROM  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05353153
• Other study ID #: 2021_0409
• Secondary ID: 2021-A02139-32
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2022
• Est. completion date: September 2024

Study information

• Verified date: April 2022
• Source: University Hospital, Lille
• Contact: Sara BALAGNY, MD
• Phone: 0320445962
• Email: sara.balagny[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Premature Birth
• Preterm Premature Rupture of Membrane
• Rupture

Intervention

Other:
• hypnosis
Hypnosis-based intervention with two sessions of hypnosis (focusing on the treatment of anxiety)
• standart care
no intervention no hypnosis

Locations

Country	Name	City	State
France	Hop Claude Huriez, Had, Chu Lille	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Laboratory of Psychopathology and Health Processes, University of Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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