UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025855 |
|---|---|
| Receipt number | R000029731 |
| Scientific Title | An open-label uncontrolled trial of the efficacy and safety of a hug for promotion of relaxation in pediatric patients with severe motor and intellectual disabilities. |
| Date of disclosure of the study information | 2017/02/27 |
| Last modified on | 2018/01/28 17:59:17 |
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Basic information
Public title
An open-label uncontrolled trial of the efficacy and safety of a hug for promotion of relaxation in pediatric patients with severe motor and intellectual disabilities.
Acronym
An open-label uncontrolled trial of the efficacy and safety of a hug for promotion of relaxation in patients with severe motor and intellectual disabilities.
Scientific Title
An open-label uncontrolled trial of the efficacy and safety of a hug for promotion of relaxation in pediatric patients with severe motor and intellectual disabilities.
Scientific Title:Acronym
An open-label uncontrolled trial of the efficacy and safety of a hug for promotion of relaxation in patients with severe motor and intellectual disabilities.
Region
| Japan |
Condition
Condition
Severe motor and intellectual disabilities
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of a hug as practice of educational therapy for promotion of relaxation in multiple and severely handicapped children who need regular and critical medical care.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
High-Frequency (HF) components by frequency analysis of heart rate variability.
Key secondary outcomes
Low-Frequency (LF)/HF components by frequency analysis of heart rate variability, activity value of salivary amylase, incidence rate of adverse event, appearance change (in facial expression, body movements).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Practice of educational therapy is implemented by a systematic combination of an educational therapist or a nursery teacher who directly performs the therapy (a hug) to the child, an assistant to measure heart rate and activity value of salivary amylase, etc. before and after a hug, and a doctor or a nurse who performs medical observation, once a week for 24 weeks.
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Children with a score of multiple and severely handicapped children of 25 or more.
2) Children who need treatment of tracheotomy or artificial respirator.
3) Children who are 17 years old or younger.
4) Children with lower body weight than 20 kg.
5) Children whose consent for participation in this study is provided by the representative.
Key exclusion criteria
1) Children for whom the principal investigator or other investigators decided not suitable for participation in this study.
2) Children who became multiple and severely handicapped due to traumas of traffic injury, etc..
3) Children who need sustained continuous suction.
4) Children with a history of bone fracture within 3 years until the time of registration.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Aritomo Ao |
Organization
National Hospital Organization
Shizuoka Institute of Epilepsy and Neurological Disorders
Division name
Educational Therapy
Zip code
Address
886 Urushiyama, Aoi-ku, Shizuoka, 420-8688, Japan
TEL
054-245-5446
shujidou@shizuokamind.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Aritomo Ao |
Organization
National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
Division name
Educational Therapy
Zip code
Address
886 Urushiyama, Aoi-ku, Shizuoka, 420-8688, Japan
TEL
054-245-5446
Homepage URL
shujidou@shizuokamind.org
Sponsor or person
Institute
National Hospital Organization
Shizuoka Institute of Epilepsy and Neurological Disorders
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
青森病院(青森県)、新潟病院(新潟県)、下志津病院(千葉県)、南京都病院(京都府)、静岡てんかん・神経医療センター(静岡県)、豊橋医療センター(愛知県)、東名古屋病院(愛知県)、兵庫あおの病院(兵庫県)、高知病院(高知県)、敦賀医療センター(福井県)、甲府病院(山梨県)、松江医療センター(島根県)、宮崎病院(宮崎県)、四国こどもとおとなの医療センター(香川県)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 09 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 26 | Day |
Last modified on
| 2018 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029731
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
