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Eye Movement Desensitization and Reprocessing treatment in pregnant women with Fear of Childbirth


- candidate number21879
- NTR NumberNTR5122
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-mrt-2015
- Secondary IDsNL4930510014 VCMO toetsingsnummer
- Public TitleEye Movement Desensitization and Reprocessing treatment in pregnant women with Fear of Childbirth
- Scientific TitleEMDR in pregnant women with Fear of Childbirth (FoC)
- ACRONYMEMDR_FoC
- hypothesisOur hypotheses are that in follow-up measurement compared to pretreatment-measurement: 1) WITHIN treatment group there will be a decrease in the severity of the FoC symptoms, and 2) BETWEEN treatment group and care-as-usual group there will be less severe FoC symptoms, less caesarean sections, lower health care costs, and a more positive childbirth experience. Last hypothesis is 3) that EMDR does not lead to more obstetrical or neonatal complications.
- Healt Condition(s) or Problem(s) studiedPregnancy, Post traumatic stress disorder, Labour, EMDR, Post partum
- Inclusion criteriaPregnant women with a gestational age of 8-20 weeks, who mastered the Dutch language
- Exclusion criteria<18 years old,
current psychological treatment
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2015
- planned closingdate1-okt-2016
- Target number of participants120
- InterventionsCare-as-usual group: care-as-usual is defined as standard care during pregnancy, with routine obstetrical checks. Assuming good clinical care, anxious pregnant women will receive more counseling compared to not-anxious pregnant women, but will (probably) not be referred for EMDR.

Eye Movement Desensitization and Reprocessing (EMDR) group: EMDR is a psychological intervention that was developed for the treatment of traumatic memories. It is internationally recognized as a first choice therapy for treating posttraumatic stress disorder. EMDR is conducted according to the Dutch translation of the basic EMDR protocol 2015, and is provided in 3 sessions of 90 minutes. Eye movements were applied as the distracting stimulus.
- Primary outcomeSeverity of FoC
- Secondary outcomeObstetrical and neonatal complications, percentage caesarean sections, subjective childbirth experience, health care costs.
- TimepointsData will be collected at several timepoints:
-Screening (gestational age 8-20 weeks)
-T0:Pre-assessment (circa 20 weeks gestational age)
-In between sessions (every two weeks for care as usual)
-T1: Post-treatment antepartum (30-32 weeks gestational age)
-T2: Post-treatment postpartum (2-3months postpartum)
- Trial web sitewww.olvg.nl/optimum
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. M.G. van Pampus
- CONTACT for SCIENTIFIC QUERIESDr. M.G. van Pampus
- Sponsor/Initiator Onze Lieve Vrouwe Gasthuis (OLVG)
- Funding
(Source(s) of Monetary or Material Support)
Vereniging EMDR Nederland (VEN)
- Publications
- Brief summaryAbout 6-10% of pregnant women have severe Fear of Childbirth. Our objective is to assess efficacy and safety of EMDR treatment for women with Fear of Childbirth. After screening 1600 pregnant women, 120 pregnant women with Fear of Childbirth will be randomized between care-as-usual and 3 sessions of 90 minutes EMDR.
- Main changes (audit trail)
- RECORD28-mrt-2015 - 31-mei-2015


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