Clinical Trial: A Study on the Effectiveness of Digital Tools Supporting Husband-Attended Childbirth to Promote the Transition of Fatherhood Roles in the Post-COVID Era (Japan)

Tokyo, April 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061154) titled 'A Study on the Effectiveness of Digital Tools Supporting Husband-Attended Childbirth to Promote the Transition of Fatherhood Roles in the Post-COVID Era' on April 3.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Tsuruga Nursing University

Condition: Condition - Healthy maternals and husbands Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To examine the effectiveness of a digital tool supporting husband-attended childbirth in promoting the transition to fatherhood in the post-COVID era. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Period: Around March 2028 after the approval of the ethical review Number of times:1 time Contents: Explanation by delivery animation, questionnaire survey

Eligibility: Age-lower limit - 18 years-old < Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Pregnant women aged 18 or older and their husbands who are scheduled for vaginal delivery at 37 weeks of gestation or later at a single obstetric clinic located in the Hokuriku region.Marital status is not a requirement. Participants must be able to use a smartphone. Participants must be able to understand Japanese (speaking,reading,and writing). Key exclusion criteria - Any criteria other than the inclusion criteria. The questionnaire survey excludes participants whose maternal or neonatal health status was poor between the time of delivery and the time of the request (e. g.,potential for obstetric hemorrhage in the mother, severe complications,or severe complications in the newborn). Cases where delivery is imminent or participation is difficult due to delivery management considerations,etc. Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 03 Day Date of IRB - 2026 Year 03 Month 19 Day Anticipated trial start date - 2026 Year 04 Month 03 Day Last follow-up date - 2036 Year 04 Month 03 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069979

Disclaimer: Curated by HT Syndication.