Positive Adjustment Coping Intervention

Infertility/Sterility Clinical Trial

— PACI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03118219
• Other study ID #: S-074/2017
• Status: Completed
• Phase: N/A
• Start date: July 18, 2017
• Est. completion date: August 8, 2019

Study information

• Verified date: September 2019
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: August 8, 2019
• Est. primary completion date: June 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility/Sterility

Intervention

Other:
• Positive adjustment coping intervention
see arm description
• Brainteaser
see arm description

Locations

Country	Name	City	State
Germany	University Hospital Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Lancastle D, Boivin J. A feasibility study of a brief coping intervention (PRCI) for the waiting period before a pregnancy test during fertility treatment. Hum Reprod. 2008 Oct;23(10):2299-307. doi: 10.1093/humrep/den257. Epub 2008 Jul 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in the Screen IVF questionaire between the intervention groups	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	through study completion, an average of 2 years
Secondary	Quantitative evaluation of participants' opinion about the intervention	Participants will be questioned about the perceived effectiveness and practicability of the intervention techniques with quantitative items (Rating scales).	through study completion, an average of 2 years
Secondary	Qualitative evaluation of participants' opinion about the intervention	Participants will be questioned about the recommendations to others concerning the intervention techniques (open questions)	through study completion, an average of 2 years