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

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.

Study Overview

• Status: Recruiting
• Conditions: Preterm Premature Rupture of Membrane
• Intervention / Treatment: Other: hypnosis; Other: standart care

• Study Type: Interventional
• Enrollment (Anticipated): 94
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara BALAGNY, MD; Phone Number: 0320445962; Email: sara.balagny@chru-lille.fr

Study Locations

• France
  • Lille, France
    • Recruiting
    • Hop Claude Huriez, Had, Chu Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Laboratory of Psychopathology and Health Processes, University of Paris
• Investigators: Principal Investigator: Sara BALAGNY, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2022
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: April 25, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: psychology; anxiety; hypnosis; PPROM; complicated pregnancy
• Additional Relevant MeSH Terms: Wounds and Injuries; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Rupture; Premature Birth; Fetal Membranes, Premature Rupture
• Other Study ID Numbers: 2021_0409; 2021-A02139-32 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No