University Hospital Heidelberg
Heidelberg, 69120, Germany
NCT Number: NCT03118219
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.
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Interventional
Not applicable
Heidelberg, 69120, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All couples undergoing infertility treatment (in vitro fertilization or intracytoplasmic sperm injection) at the Department of Gynecologic Endocrinology and Fertility Disorders at Heidelberg University Women's Hospital, which have
If one partner is refusing to participate, the other person may be admitted as an individual.
Exclusion criteria
see arm description
see arm description
Other names: Comparison intervention group
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
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).
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)
University Hospital Heidelberg
Other
Positive Adjustment in Case of Involuntary Childlessness - a Smartphone-supported Intervention Study as RCT
Acronym: PACI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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