Ignite Creation Date:
2024-05-06 @ 1:00 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01701011
Status:
COMPLETED
Last Update Posted:
2016-08-10
First Post:
2010-10-06
Brief Title:
Coping Intervention After Embryo Transfer
Sponsor:
Bart CJM Fauser
Organization:
UMC Utrecht
Study Overview
Official Title:
Study of the Effectiveness of a Coping Selfhelp Intervention for Women in the Waiting Period After an Embryo Transfer During an IVFISCI Treatment
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 parametersoutcome of the study
Anxiety
Secondary study parametersoutcome 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
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 parametersoutcome of the study
Anxiety
Secondary study parametersoutcome 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None