Ignite Creation Date:
2024-05-06 @ 9:56 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03118219
Status:
COMPLETED
Last Update Posted:
2019-09-30
First Post:
2017-03-29
Brief Title:
Positive Adjustment Coping Intervention
Sponsor:
University Hospital Heidelberg
Organization:
University Hospital Heidelberg
Study Overview
Official Title:
Positive Adjustment in Case of Involuntary Childlessness - a Smartphone-supported Intervention Study as RCT
Status:
COMPLETED
Status Verified Date:
2019-09
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:
PACI
Brief Summary:
Involuntary childlessness is experienced as emotionally stressful however psychosocial counseling is not always available on the spot Aim of this RCT study is to examine the efficacy and acceptance of a psychological low-dose online intervention for couples in reproductive treatment
Detailed Description:
About 8 of all couples of reproductive age are involuntary childless and just about 25000 couples receive a medical treatment each year in Germany which is experienced as roller coaster of emotions The positive effect of face-to-face counseling for couples with a desire for children has been proven However this does not yet apply to a variety of other forms of intervention eg telephone or online counseling
In this study the effectiveness of a smartphone-supported psychosocial intervention for women and men in reproductive treatment will be examined in a randomized controlled pre-post design
For this purpose an intervention group and a comparison intervention group of each n 60 couples in reproductive treatment will be examined at two points during a four-week interval using the ScreenIVF questionaire The ScreenIVF will be completed paper-pencil before the intervention and online after the intervention In the fourteen-day waiting period between oocyte puncture and pregnancy test or the reappearance of menstruation both groups receive either positive adjustment techniques or brainteasersIn addition both groups are questioned one month after the post-measurement date on the perceived effectiveness and practicability of the intervention techniques
Sociodemographic variables such as age education and medical data such as diagnosis previous treatment cycles as potential moderators as well as possible pregnancies at the second measurement time will be reported
No adverse effects or other risks are expected for the study participants
In this study the effectiveness of a smartphone-supported psychosocial intervention for women and men in reproductive treatment will be examined in a randomized controlled pre-post design
For this purpose an intervention group and a comparison intervention group of each n 60 couples in reproductive treatment will be examined at two points during a four-week interval using the ScreenIVF questionaire The ScreenIVF will be completed paper-pencil before the intervention and online after the intervention In the fourteen-day waiting period between oocyte puncture and pregnancy test or the reappearance of menstruation both groups receive either positive adjustment techniques or brainteasersIn addition both groups are questioned one month after the post-measurement date on the perceived effectiveness and practicability of the intervention techniques
Sociodemographic variables such as age education and medical data such as diagnosis previous treatment cycles as potential moderators as well as possible pregnancies at the second measurement time will be reported
No adverse effects or other risks are expected for the study participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None