UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057014 |
|---|---|
| Receipt number | R000065162 |
| Scientific Title | Investigating the effects of Tactile Care on reducing anxiety in mothers of children with developmental disorders |
| Date of disclosure of the study information | 2025/02/15 |
| Last modified on | 2025/02/13 15:18:10 |
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Basic information
Public title
Investigation of the effects of Tactile Care for mothers of children with developmental disorders
Acronym
Effects of Tactile Care
Scientific Title
Investigating the effects of Tactile Care on reducing anxiety in mothers of children with developmental disorders
Scientific Title:Acronym
The anxiety-reducing effect of Tactile Care
Region
| Japan |
Condition
Condition
Mother of a child with developmental disabilities
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the physiological and psychological effects on mothers of children with developmental disorders who receive Tactile Care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
1.Tactile Care has an effect on physiological indicators such as body temperature, breathing, heart rate, time to fall asleep, and sleep time after the intervention.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention period: The therapist provide Tactile Care to the participant's back every other week. (for 3 months, 6 times)
Interventions/Control_2
Non-intervention period: Participants sit quietly for 10 minutes every other week. (for 3 months, 6 times)
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
| 25 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Participants are mothers of children with developmental disorders. (elementary and junior high school students)
2.Mothers can participate in the measurements. (every other week)
3.Participants can wear the measurement device on their wrists and install the app on their smartphones. (6 months)
4.Participants can have the therapist touch their back.
Key exclusion criteria
The exclusion criteria are as follows: pregnant or possibly pregnant, uncomfortable with being touched, no experience of bring up after a child with a developmental disorder, currently undergoing treatment for depression.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Chieko |
| Middle name | |
| Last name | Takasuka |
Organization
Kanon Matsuyama Co., Ltd, Matsuyama, Japan
Division name
Davelopment of support room Dekopon
Zip code
791-8013
Address
5-8-6, Yamagoe, Matsuyama-shi, Ehime, Japan
TEL
089-925-2525
ruihimepom@gmail.com
Public contact
Name of contact person
| 1st name | Chieko |
| Middle name | |
| Last name | Takasuka |
Organization
Kanon Matsuyama Co., Ltd, Matsuyama, Japan
Division name
Davelopment of support room Dekopon
Zip code
791-8013
Address
5-8-6, Yamagoe, Matsuyama-shi, Ehime, Japan
TEL
089-925-2525
Homepage URL
ruihimepom@gmail.com
Sponsor or person
Institute
Kanon Matsuyama Co., Ltd, Matsuyama, Japan
Institute
Department
Personal name
Funding Source
Organization
Kanon Matsuyama Co., Ltd, Matsuyama, Japan
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanon Matsuyama Co., Ltd, Matsuyama, Japan
Address
5-8-6, Yamagoe, Mtauyama-shi, Ehime, Japan
Tel
089-925-2525
ruihimepom@gmail.com
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
発達支援ルームでこポン（愛媛県） Development of sapport room Dekopon(Ehime)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 15 | 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
6
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 | 01 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | 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 | 02 | Month | 13 | Day |
Last modified on
| 2025 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065162
