Coping Intervention After Embryo Transfer
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| ClinicalTrials.gov Identifier: NCT01701011 |
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Recruitment Status :
Completed
First Posted : October 4, 2012
Results First Posted : December 22, 2014
Last Update Posted : August 10, 2016
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Background of the study:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anxiety Depression | Behavioral: Coping intervention | Not Applicable |
Objective of the study:
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 377 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Official Title: | Study of the Effectiveness of a Coping Selfhelp Intervention for Women in the Waiting Period After an Embryo Transfer During an IVF/ISCI Treatment |
| Study Start Date : | October 2010 |
| Actual Primary Completion Date : | February 2013 |
| Actual Study Completion Date : | February 2013 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: PRCI-monitoring
Coping intervention, Daily Record Keeping, Questionnaires
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Behavioral: Coping intervention
Positive reappraisal coping intervention |
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No Intervention: Routine care control
Questionnaires
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No Intervention: Monitoring control
DRK and Questionnaires
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- Anxiety [ Time Frame: T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer ]The Hospital Anxiety and Depression Scale (HADS) was used to measure general anxiety and depression (Zigmond and Snaith, 1983). TheHADSconsists of 14 items (7 items for each subscale) that are rated on a 4-point Likert scale. The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0 to 21). Scores on each scale can be interpreted in ranges: normal (0-7), mild (8-10), moderate (11-14) and severe (15-21) anxiety and depression.
- Depression [ Time Frame: T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer ]The Hospital Anxiety and Depression Scale (HADS) was used to measure general anxiety and depression (Zigmond and Snaith, 1983). TheHADSconsists of 14 items (7 items for each subscale) that are rated on a 4-point Likert scale. The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0 to 21). Scores on each scale can be interpreted in ranges: normal (0-7), mild (8-10), moderate (11-14) and severe (15-21) anxiety and depression.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Patient in IVF/ICSI treatment
Exclusion Criteria:
- Patient who do not speak the dutch language
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01701011
| Netherlands | |
| University Medical Center Utrecht | |
| Utrecht, Netherlands, : PO Box 85500 | |
| Principal Investigator: | N.S. Macklon, MD, PhD | University of Southampton | |
| Principal Investigator: | J Boivin, PhD | Cardiff University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bart CJM Fauser, prof, UMC Utrecht |
| ClinicalTrials.gov Identifier: | NCT01701011 |
| Other Study ID Numbers: |
PRCI study |
| First Posted: | October 4, 2012 Key Record Dates |
| Results First Posted: | December 22, 2014 |
| Last Update Posted: | August 10, 2016 |
| Last Verified: | June 2016 |
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coping intervention waiting-period |
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Depression Behavioral Symptoms |