Tokyo, July 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058439) titled 'Development of a Nursing Support Program for Primiparous Women to Regulate Sleep-Wake Rhythm up to Two Months Postpartum' on July 12.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - University of Hyogo

Condition: Condition - Healthy primiparous women Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aimed to develop a nursing support program for primiparous women to improve their sleep quality primarily by regulating the sleep-wake rhythm and to demonstrate the effectiveness of the program when administered to primiparous women during pregnancy and up to 2 months postpartum. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - We developed a program based on Orem's Self-care Theory to support women juggling dual roles in self-care and dependent care for their infants to practice self-care for sleep. The program was administered to the individual participants twice between 28 and 36 weeks of pregnancy and once each at 2 weeks and 1 month postpartum. In the first program session during pregnancy, we provided information on how to induce sleep in the postpartum period, the sleep characteristics of infants, and postpartum daily life schedules. In addition, we asked the participants to discuss their postpartum daily life routines with their families. In the second session, we provided the participants with instructions and a practice session on breastfeeding using a doll. In addition, we reviewed their discussions with their families about their postpartum daily living. During the two sessions after childbirth, we assessed the sleep and breastfeeding status of the participating mothers so that we could provide nursing care to enable them to practice self-care for sleep and breastfeeding. Interventions/Control_2 - Standard of care

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Female Key inclusion criteria - Between 28 and 32 weeks of their first pregnancy women Key exclusion criteria - Women who are receiving psychiatric, neurological or psychosomatic treatment during pregnancy. Target Size - 80

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2022 Year 07 Month 22 Day Date of IRB - 2022 Year 07 Month 22 Day Anticipated trial start date - 2022 Year 10 Month 22 Day Last follow-up date - 2025 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065871

Disclaimer: Curated by HT Syndication.