NCT05353153

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

June 3, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

2.6 years

First QC Date

April 25, 2022

Last Update Submit

December 18, 2025

Conditions

Preterm Premature Rupture of Membrane

Keywords

PPROMhypnosispsychologyanxietycomplicated pregnancy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Pregnancy related anxiety by PRAQ-R2

    1 time at baseline

  • Pregnancy related anxiety by PSAS

    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

    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

    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

    At 1 day to 7 days postpartum

  • +4 more secondary outcomes

Study Arms (2)

hypnosis group

EXPERIMENTAL
Other: hypnosis

Control group

ACTIVE COMPARATOR
Other: standart care

Interventions

standart careOTHER

no intervention no hypnosis

Control group
hypnosisOTHER

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

hypnosis group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsno upper age limit, all women at age to reproduct
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being an adult French-speaking woman,
  • primi or multipara,
  • less than 33 weeks and 6 days of amenorrhea
  • having being diagnosed with PPROM

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hop Claude Huriez, Had, Chu Lille

Lille, France

Location

MeSH Terms

Conditions

Preterm Premature Rupture of the MembranesAnxiety DisordersPregnancy Complications

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Mental DisordersFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sara BALAGNY, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2022

First Posted

April 29, 2022

Study Start

June 3, 2022

Primary Completion

January 10, 2025

Study Completion

January 10, 2025

Last Updated

December 26, 2025

Record last verified: 2025-12

Locations

FR(1)