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Completed

NCT Number: NCT05353153

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

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.

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Key information

Conditions

Preterm Premature Rupture of Membrane Anxiety Disorders Female Urogenital Diseases and Pregnancy Complications Mental Disorders Pregnancy Complications Preterm Premature Rupture of the Membranes Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hop Claude Huriez, Had, Chu Lille

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypnosis

Other

Hypnosis-based intervention with two sessions of hypnosis (focusing on the treatment of anxiety)

standart care

Other

no intervention no hypnosis

Primary outcomes

  1. State anxiety by STAI-Y-A scale

    Time frame: 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 outcomes

  1. Pregnancy related anxiety by PRAQ-R2

    Time frame: 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)

  2. Pregnancy related anxiety by PSAS

    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)

    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)

  3. State anxiety by STAI-Y-A

    Time frame: 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

  4. Perinatal depression by EPDS

    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)

    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

  5. Childbirth experience by QEVA

    Time frame: 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.

  6. Labor agentry by LAS ( Labor Agentry Scale)

    Time frame: 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.

  7. Perinatal bonding by PAI

    Time frame: 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

  8. postnatal bonding by PPBQ

    Time frame: 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

  9. Pain Visual Analog Scale by EVA

    Time frame: 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".

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Laboratory of Psychopathology and Health Processes, University of Paris

Registry information

Acronym: HYPNOPROM

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 29, 2022
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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