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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025855
Receipt No. 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

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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
Email 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
Email shujidou@shizuokamind.org

Sponsor
Institute National Hospital Organization
Shizuoka Institute of Epilepsy and Neurological Disorders
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029731

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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