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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.

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. - 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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000025855
Enrollment
20
Registered
2017-02-27
Start date
2017-02-27
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe motor and intellectual disabilities

Interventions

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 meas

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
High-Frequency (HF) components by frequency analysis of heart rate variability.

Secondary

MeasureTime frame
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).

Countries

Japan

Contacts

Public ContactAritomo Ao

National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders Educational Therapy

shujidou@shizuokamind.org054-245-5446

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026