Skip to main content
OpenTrials
Completed

NCT Number: NCT03118219

Positive Adjustment Coping Intervention

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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Heidelberg

Heidelberg, 69120, Germany

About this study

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.

Who can participate

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

  • 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

Treatment and study plan

Positive adjustment coping intervention

Other

see arm description

Brainteaser

Other

see arm description

Other names: Comparison intervention group

Primary outcomes

  1. 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

Secondary outcomes

  1. 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).

  2. 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)

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Registry information

Official study title

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

Acronym: PACI

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 18, 2017
Registry last updated
Sep 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.