NCT03118219|Completed
Positive Adjustment Coping Intervention
PACI
Positive Adjustment in Case of Involuntary Childlessness - a Smartphone-supported Intervention Study as RCT
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PACI
Positive Adjustment in Case of Involuntary Childlessness - a Smartphone-supported Intervention Study as RCT
Sponsor study identifier
interventional
401
1 country
1
Study Start
July 18, 2017
Actual (reported)Primary Completion
June 12, 2019
Actual (reported)Study Completion
August 8, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 8, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 29, 2017
Actual (reported)April 18, 2017
Actual (reported)July 18, 2017
Actual (reported)June 12, 2019
Actual (reported)August 8, 2019
Actual (reported)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
Quantitative evaluation of participants' opinion about the intervention
through study completion, an average of 2 years
Qualitative evaluation of participants' opinion about the intervention
through study completion, an average of 2 years
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.
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.
see arm description
see arm description
University Hospital Heidelberg
Heidelberg, 69120, Germany
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.
Kremer F, Schick M, Roesner S, Germeyer A, Moessner M, Bauer S, Ditzen B, Wischmann T. Smartphone-supported Positive Adjustment Coping Intervention (PACI) for couples undergoing fertility treatment: A randomised controlled trial. PLoS One. 2025 Dec 8;20(12):e0335776. doi: 10.1371/journal.pone.0335776. eCollection 2025.
Tewes Wischmann, PD Dr.
University Hospital Heidelberg
401 participants (actual enrollment reported by the registry).
First Submitted
March 29, 2017
First Posted
April 18, 2017
Study Start
July 18, 2017
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.
Schick M, Roesner S, Germeyer A, Moessner M, Bauer S, Ditzen B, Wischmann T. Smartphone-supported Positive Adjustment Coping Intervention (PACI) for couples undergoing fertility treatment: a randomised controlled trial protocol. BMJ Open. 2019 Jul 9;9(7):e025288. doi: 10.1136/bmjopen-2018-025288.
Primary Completion
June 12, 2019
Actual (reported)Study Completion
August 8, 2019
Actual (reported)Last Updated
September 30, 2019
Record last verified: 2019-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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