Tokyo, Aug. 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058762) titled 'Efficacy of Contact Needle Therapy (Non-insertive Acupuncture, CNT) for Night Crying in Infants and Toddlers: A Crossover Trial' on Aug. 12.

Study Type: Interventional

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

Primary Sponsor: Institute - Hiroshima University Hospital

Condition: Condition - nighttime crying Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to evaluate the efficacy and safety of contact needle therapy for night crying in infants and toddlers. Using a crossover trial design, the intervention period with contact needle therapy will be compared with a non-intervention period to assess changes in indicators such as the frequency of nighttime awakenings, duration of crying, and parental childcare-related stress. These outcomes will be evaluated using questionnaires and an actigraph. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Infants and toddlers aged 6 to 48 months attending the Tanpopo Nursery School, Hiroshima University Interventions/Control_2 - After obtaining informed consent, participants will be randomly assigned to either the early intervention group, which begins acupuncture treatment immediately after the start of the trial, or the late intervention group, which begins treatment two weeks after the trial starts. The treatment period consists of pediatric acupuncture administered three times per week for two weeks, for a total of six sessions. The treatment will be performed on the whole body following standard pediatric acupuncture techniques. An actigraph will be worn before and after the treatment period to record sleep data. In addition, the participants parents or guardians will be asked to complete questionnaires before and after the treatment period.

Eligibility: Age-lower limit - 6 months-old = Gender - Male and Female Key inclusion criteria - 1. Infants and toddlers aged 6 to 48 months attending the Tanpopo Nursery School, Hiroshima University

2. Children without sleep-disrupting diseases or other health problems, who are considered to have night crying (waking up crying at night three or more times per week)

3. Children not receiving other acupuncture or moxibustion treatments

4. Children whose parents or guardians have provided written informed consent after receiving an adequate explanation of the study Key exclusion criteria - 1. Children with any of the following comorbidities: Congenital diseases Seizures or paroxysmal disorders Heart diseases

2. Children deemed unsuitable by the principal investigator or co-investigators for any other reason Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 15 Day Anticipated trial start date - 2025 Year 09 Month 01 Day Last follow-up date - 2026 Year 04 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067190

Disclaimer: Curated by HT Syndication.