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Positive Adjustment Coping Intervention (PACI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03118219
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Maren Schick, University Hospital Heidelberg

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.

Condition or disease Intervention/treatment Phase
Infertility/Sterility Other: Positive adjustment coping intervention Other: Brainteaser Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 401 participants
Allocation: Randomized
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

Arm Intervention/treatment
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

Brainteaser
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.
Other: Brainteaser
see arm description
Other Name: Comparison intervention group




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Germany
University Hospital Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
University Hospital Heidelberg
Investigators
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Study Director: Tewes Wischmann, PD Dr. University Hospital Heidelberg
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Study Data can be requested per mail to Tewes Wischmann

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maren Schick, Principal Investigator, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT03118219    
Other Study ID Numbers: S-074/2017
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maren Schick, University Hospital Heidelberg:
assisted reproductive technology
embryo transfer
online intervention
rct
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female