Clinical Trial: A Study on the Effects of Timing in Toy-Based Group Work Interventions on Development and Maternal Psychology in Preterm Infants (Japan)

Tokyo, Dec. 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060103) titled 'A Study on the Effects of Timing in Toy-Based Group Work Interventions on Development and Maternal Psychology in Preterm Infants' on Dec. 18.

Study Type: Interventional

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

Primary Sponsor: Institute - Toyama university hospital

Condition: Condition - preterm infant Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study examines the effects of differing start times for developmental support interventions on the development of preterm infants and the psychological well-being of their mothers. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Toys are provided monthly for a total of 6 sessions at 1 year old. Receipt occurs monthly during outpatient visits. Our clinical psychologist instructs mothers each time on toy utilization methods and developmentally stimulating play approaches, then conducts group work sessions gathering children of the same age. Interventions/Control_2 - Toys are provided monthly for a total of 6 sessions at 1 and 6 month year old. Receipt occurs monthly during outpatient visits. Our clinical psychologist instructs mothers each time on toy utilization methods and developmentally stimulating play approaches, then conducts group work sessions gathering children of the same age.

Eligibility: Age-lower limit - 1 years-old = Gender - Male and Female Key inclusion criteria - preterm infants less than gestational age 32 weeks Key exclusion criteria - Infants and their mothers deemed inappropriate by the principal investigator, including those with congenital disorders, severe intraventricular hemorrhage (grade 3 or 4), or non-native Japanese speakers. Target Size - 74

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 10 Day Date of IRB - 2025 Year 12 Month 10 Day Anticipated trial start date - 2026 Year 01 Month 15 Day Last follow-up date - 2028 Year 08 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068744

Disclaimer: Curated by HT Syndication.