Study Results
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View full resultsBasic Information
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COMPLETED
NA
377 participants
INTERVENTIONAL
2010-10-31
2013-02-28
Brief Summary
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Undergoing an IVF or ICSI treatment is an emotional and physical burden for both the woman and her partner. Most stressful for the couple is waiting for the result of the treatment, the period after the embryotransfer until the pregnancy test or menstruation and an unsuccessful treatment. Symptoms of anxiety and depression have been identified in couples during the waitingperiod after an embryotransfer. For this waitingperiod a short selfhelp copingintervention has been developed based on the stress theory of Lazarus for women to use at home. Goal of the instrument is to stimulate the copingstyle positive reappraisal. Research has demonstrated that using this copingstyle can have a positive impact in health related circumstances.
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Detailed Description
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To investigate if a short copingintervention reduces anxiety in patients undergoing an IVF or ICSI treatment in the UMCU during the waitingperiod after an embryotransfer.
Study design:
In this research a randomised controlled trial (RCT) will be used for three groups. The choice for three groups has been based on earlier research with a daily record keeping (DRK). The DRK is a daily measurement for emotions, copingstyle and physical complaints. Previous research with the DRK showed an increase of anxiety. More research must be done of the impact of the DRK. Group 1: Positive Reappraisal Coping Intervention (PRCI) \& DRK \& questionnaires Group 2: DRK \& questionnaires Group 3: Standard care \& questionnaires
Study population:
Patients undergoing an IVF or ICSI treatment in the UMCU.
Intervention (if applicable):
A selfhelp coping intervention
Primary study parameters/outcome of the study:
Anxiety
Secondary study parameters/outcome of the study (if applicable):
Risk of emotional problems copingstyle depression vital pregnancy quality of life
Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):
Using the coping intervention may reduce anxiety for the patient. The use of this instrument is not a burden for patients. The burden for patients is to complete questionnaires before, during and six weeks after the embryotransfer. Partners are asked to fill in a questionnaire at three times.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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PRCI-monitoring
Coping intervention, Daily Record Keeping, Questionnaires
Coping intervention
Positive reappraisal coping intervention
Routine care control
Questionnaires
No interventions assigned to this group
Monitoring control
DRK and Questionnaires
No interventions assigned to this group
Interventions
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Coping intervention
Positive reappraisal coping intervention
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
FEMALE
Yes
Sponsors
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Bart CJM Fauser
OTHER
Responsible Party
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Bart CJM Fauser
prof
Principal Investigators
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N.S. Macklon, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Southampton
J Boivin, PhD
Role: PRINCIPAL_INVESTIGATOR
Cardiff University
Locations
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University Medical Center Utrecht
Utrecht, Utrecht, Netherlands
Countries
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References
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Ockhuijsen H, van den Hoogen A, Eijkemans M, Macklon N, Boivin J. The impact of a self-administered coping intervention on emotional well-being in women awaiting the outcome of IVF treatment: a randomized controlled trial. Hum Reprod. 2014 Jul;29(7):1459-70. doi: 10.1093/humrep/deu093. Epub 2014 May 7.
Ockhuijsen HD, van den Hoogen A, Macklon NS, Boivin J. The PRCI study: design of a randomized clinical trial to evaluate a coping intervention for medical waiting periods used by women undergoing a fertility treatment. BMC Womens Health. 2013 Sep 3;13:35. doi: 10.1186/1472-6874-13-35.
Related Links
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Article study protocol
Other Identifiers
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PRCI study
Identifier Type: -
Identifier Source: org_study_id
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