Preterm Premature Rupture of MembraneHYPNOPROMNCT05353153
The Psychological Experience of Pathological Pregnancy. Study of the Case of Premature Rupture of Membranes and Evaluation of the Impact of Hypnosis Support
A study testing hypnosis and standart care in people with Preterm Premature Rupture of Membrane, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Premature Rupture of Membrane
- What is being tested?
- hypnosis and standart care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jun 2022to 10 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being an adult French-speaking woman,
- primi or multipara,
- less than 33 weeks and 6 days of amenorrhea
- having being diagnosed with PPROM
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Preterm Premature Rupture of Membrane
- Being tested
- hypnosis, standart care
- Keywords
- PPROM, hypnosis, psychology, anxiety, complicated pregnancy
- Medical subject headings
- Preterm Premature Rupture of the Membranes, Anxiety Disorders, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypnosisOther
Hypnosis-based intervention with two sessions of hypnosis (focusing on the treatment of anxiety)
standart careOther
no intervention no hypnosis
| Study group | Role | What they receive |
|---|---|---|
| hypnosis group | Experimental | Not described Receives: Other: hypnosis |
| Control group | Active comparator | Not described Receives: Other: standart care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: between baseline and 3-week (+/- 1 week) prenatal measurement
Secondary outcomes (9)
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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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".
Measured: At 2 time points in the postnatal period : at 1 day to 7 days postpartum and at 4 to 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start3 Jun 2022
- Primary completion10 Jan 2025
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Premature Rupture of MembraneStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratory of Psychopathology and Health Processes, University of Paris
- Responsible party
- Sponsor
- Investigators
- Sara BALAGNY, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353153
- Sponsor's protocol ID
- 2021_0409
- Other IDs
- 2021-A02139-32
- Acronym
- HYPNOPROM
- Status last verified
- Dec 2025
- First submitted
- 25 Apr 2022
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05353153
- Acronym / sponsor ID
- HYPNOPROM / 2021_0409
- Conditions
- Preterm Premature Rupture of Membrane
- Keywords
- PPROM, hypnosis, psychology, anxiety, complicated pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Laboratory of Psychopathology and Health Processes, University of Paris
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypnosis group | Experimental | Other: hypnosis |
| Control group | Active comparator | Other: standart care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being an adult French-speaking woman,
- primi or multipara,
- less than 33 weeks and 6 days of amenorrhea
- having being diagnosed with PPROM
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypnosisHypnosis-based intervention with two sessions of hypnosis (focusing on the treatment of anxiety) | Other | hypnosis group |
| standart careno intervention no hypnosis | Other | Control group |
Primary outcome
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).
9 secondary outcomes
Pregnancy related anxiety by PRAQ-R2
Time frame: 1 time at baseline
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)
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)
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)
Childbirth experience by QEVA
Time frame: At 1 day to 7 days postpartum
Labor agentry by LAS ( Labor Agentry Scale)
Time frame: at one point at 1day to 7 days postpartum
Perinatal bonding by PAI
Time frame: At one point at baseline
postnatal bonding by PPBQ
Time frame: at 4 to 6 weeks postpartum
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara BALAGNY, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypnosis and standart care in people with Preterm Premature Rupture of Membrane, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State anxiety by STAI-Y-A scale (time frame: between baseline and 3-week (+/- 1 week) prenatal measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.