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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 (HYPNOPROM)

Primary Purpose

Preterm Premature Rupture of Membrane

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
hypnosis
standart care
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preterm Premature Rupture of Membrane focused on measuring PPROM, hypnosis, psychology, anxiety, complicated pregnancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hop Claude Huriez, Had, Chu LilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

hypnosis group

Control group

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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)
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)
State anxiety by STAI-Y-A
The change in anxiety-status level between the baseline measurement and the postnatal measurements
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
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.
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.
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
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
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".

Full Information

First Posted
April 25, 2022
Last Updated
November 8, 2022
Sponsor
University Hospital, Lille
Collaborators
Laboratory of Psychopathology and Health Processes, University of Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05353153
Brief Title
The Psychological Experience of Pathological Pregnancy. Study of the Case of Premature Rupture of Membranes and Evaluation of the Impact of Hypnosis Support
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 3, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Laboratory of Psychopathology and Health Processes, University of Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Premature Rupture of Membrane
Keywords
PPROM, hypnosis, psychology, anxiety, complicated pregnancy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
hypnosis group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
hypnosis
Intervention Description
Hypnosis-based intervention with two sessions of hypnosis (focusing on the treatment of anxiety)
Intervention Type
Other
Intervention Name(s)
standart care
Intervention Description
no intervention no hypnosis
Primary Outcome Measure Information:
Title
State anxiety by STAI-Y-A scale
Description
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).
Time Frame
between baseline and 3-week (+/- 1 week) prenatal measurement
Secondary Outcome Measure Information:
Title
Pregnancy related anxiety by PRAQ-R2
Description
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)
Time Frame
1 time at baseline
Title
Pregnancy related anxiety by PSAS
Description
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)
Time Frame
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)
Title
State anxiety by STAI-Y-A
Description
The change in anxiety-status level between the baseline measurement and the postnatal measurements
Time Frame
between the baseline measurement and the postnatal measurements ( at 1 day to 7 days postpartum and at 4 to 6 weeks postpartum)
Title
Perinatal depression by EPDS
Description
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
Time Frame
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)
Title
Childbirth experience by QEVA
Description
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.
Time Frame
At 1 day to 7 days postpartum
Title
Labor agentry by LAS ( Labor Agentry Scale)
Description
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.
Time Frame
at one point at 1day to 7 days postpartum
Title
Perinatal bonding by PAI
Description
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
Time Frame
At one point at baseline
Title
postnatal bonding by PPBQ
Description
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
Time Frame
at 4 to 6 weeks postpartum
Title
Pain Visual Analog Scale by EVA
Description
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".
Time Frame
At 2 time points in the postnatal period : at 1 day to 7 days postpartum and at 4 to 6 weeks postpartum

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
no upper age limit, all women at age to reproduct
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara BALAGNY, MD
Phone
0320445962
Email
sara.balagny@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara BALAGNY, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hop Claude Huriez, Had, Chu Lille
City
Lille
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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