UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058762 |
|---|---|
| Receipt number | R000067190 |
| Scientific Title | Efficacy of Contact Needle Therapy (Non-insertive Acupuncture, CNT) for Night Crying in Infants and Toddlers: A Crossover Trial |
| Date of disclosure of the study information | 2025/08/12 |
| Last modified on | 2025/08/11 23:05:18 |
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Basic information
Public title
Efficacy of Contact Needle Therapy (Non-insertive Acupuncture, CNT) for Night Crying in Infants and Toddlers: A Crossover Trial
Acronym
Efficacy of Contact Needle Therapy (Non-insertive Acupuncture, CNT) for Night Crying in Infants and Toddlers: A Crossover Trial
Scientific Title
Efficacy of Contact Needle Therapy (Non-insertive Acupuncture, CNT) for Night Crying in Infants and Toddlers: A Crossover Trial
Scientific Title:Acronym
CNT-NC Trial
Region
| Japan |
Condition
Condition
nighttime crying
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Between-group comparison of sleep duration and sleep depth measured using the wGT3X-BT monitor (Acti Japan Co., Ltd.)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 6 | months-old | <= |
Age-upper limit
| 48 | 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 sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Tamura |
Organization
Kampo Clinical Center, Hiroshima University Hospital
Division name
Kampo Clinical Center, Hiroshima University Hospital
Zip code
7348551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima Prefecture
TEL
082-257-1921
ytamura0@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Maiko |
| Middle name | |
| Last name | Chiyokori |
Organization
Kampo Clinical Center, Hiroshima University Hospital
Division name
Kampo Clinical Center, Hiroshima University Hospital
Zip code
7348551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima Prefecture
TEL
082-257-1921
Homepage URL
chiyoman@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University Hospital
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima Prefecture
Tel
0822575555
hugcp@hiroshima-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 11 | Day |
Last modified on
| 2025 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067190
