Positive Adjustment Coping Intervention (PACI)
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|ClinicalTrials.gov Identifier: NCT03118219|
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : September 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Infertility/Sterility||Other: Positive adjustment coping intervention Other: Brainteaser||Not Applicable|
About 8% of all couples of reproductive age are involuntary childless, and just about 25,000 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, e.g. 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 brainteasers.In 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||401 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Positive Adjustment in Case of Involuntary Childlessness - a Smartphone-supported Intervention Study as RCT|
|Actual Study Start Date :||July 18, 2017|
|Actual Primary Completion Date :||June 12, 2019|
|Actual Study Completion Date :||August 8, 2019|
Experimental: Positive adjustment coping intervention
All persons allocated to the intervention group will receive daily text messages (SMS) to their smartphones with sentences for positive adjustment over two weeks starting from the day of the egg-cell punctuation.
Other: Positive adjustment coping intervention
see arm description
All persons allocated to the comparison intervention group will receive daily text messages (SMS) to their smartphones with brainteasers over two weeks starting from the day of the egg-cell punctuation.
see arm description
Other Name: Comparison intervention group
- Differences in the Screen IVF questionaire between the intervention groups [ Time Frame: through study completion, an average of 2 years ]Differences in the ScreenIVF risk profile at post-measurement time between the intervention group of positive adjustment and the intervention comparison group with the brainteasers
- Quantitative evaluation of participants' opinion about the intervention [ Time Frame: through study completion, an average of 2 years ]Participants will be questioned about the perceived effectiveness and practicability of the intervention techniques with quantitative items (Rating scales).
- Qualitative evaluation of participants' opinion about the intervention [ Time Frame: through study completion, an average of 2 years ]Participants will be questioned about the recommendations to others concerning the intervention techniques (open questions)
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): NCT03118219
|University Hospital Heidelberg|
|Heidelberg, Germany, 69120|
|Study Director:||Tewes Wischmann, PD Dr.||University Hospital Heidelberg|