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Positive Adjustment Coping Intervention

Positive Adjustment in Case of Involuntary Childlessness - a Smartphone-supported Intervention Study as RCT

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03118219
Acronym
PACI
Enrollment
401
Registered
2017-04-18
Start date
2017-07-18
Completion date
2019-08-08
Last updated
2019-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility/Sterility

Keywords

assisted reproductive technology, embryo transfer, online intervention, rct

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 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.

Interventions

OTHERPositive adjustment coping intervention

see arm description

OTHERBrainteaser

see arm description

Sponsors

University Hospital Heidelberg
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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 * agreed to participate in the study * indicated their mobile phone number * sufficient knowledge of German language. If one partner is refusing to participate, the other person may be admitted as an individual.

Exclusion criteria

* denial of participation * non-existent smartphone * insufficient knowledge of German language

Design outcomes

Primary

MeasureTime frameDescription
Differences in the Screen IVF questionaire between the intervention groupsthrough study completion, an average of 2 yearsDifferences in the ScreenIVF risk profile at post-measurement time between the intervention group of positive adjustment and the intervention comparison group with the brainteasers

Secondary

MeasureTime frameDescription
Quantitative evaluation of participants' opinion about the interventionthrough study completion, an average of 2 yearsParticipants 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 interventionthrough study completion, an average of 2 yearsParticipants will be questioned about the recommendations to others concerning the intervention techniques (open questions)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026