臨床研究等提出・公開システム

Japanese

Date of registration	Jan. 23, 2026
Last modified on	Jan. 23, 2026
Trial ID	jRCT1030250670

Scientific Title	Quantitative analysis of bio-behavioral changes in parents and children induced by physical contact
Public Title	Bio-behavioral sensing study on parent-child physical interaction

Contact for Scientific Queries	Name	Yoshida Sachine
	Affiliation	Toho University
	Address	5-21-16, Omori-Nishi, Ota-ku, Tokyo
	Telephone	+81-3-3762-4151
	E-mail	sachine.yoshida@med.toho-u.ac.jp
Contact for Public Queries	Name	Yoshida Sachine
	Affiliation	Toho University
	Address	5-21-16, Omori-Nishi, Ota-ku, Tokyo
	Telephone	+81-3-3762-4151
	E-mail	sachine.yoshida@med.toho-u.ac.jp

Recruitment status	Pending

Anticipated date of first enrollment		Jan. 23, 2026
Target sample size		100
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	crossover assignment
	purpose	basic science
Key inclusion & exclusion criteria	Inclusion Criteria	Preschool children with no physical or mental disabilities at birth or at the time of the study, regardless of gender. Parents (mothers or fathers) who are capable of performing the actions of holding and putting the preschool child to sleep without any issues. In principle, Japanese nationals. However, non-Japanese individuals are eligible if they are capable of sufficient communication in Japanese.
	Exclusion Criteria	Individuals with physical or mental disabilities at birth or at the time of the study. Individuals who have difficulty communicating in Japanese.
	Age Minimum	0age over
	Age Maximum	6age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		N/A
Intervention(s)		In this study, two types of measurements will be conducted to examine the bio-behavioral effects of daily parent-child physical interaction (holding and putting to sleep) on both parents and children. Holding Measurement (Laboratory-based): At the university laboratory, physiological changes will be compared before and during the stroking action while the parent holds the child on their lap. Measured items: Parent-child ECG, parental EMG, and child EEG (using Nihon Kohden Multi-telemetry system), as well as posture and facial expression changes recorded via video. Method: Small, lightweight sensors will be attached and fitted using medical adhesive seals or paste. Sleep-onset Measurement (Home-based or Remote): At the participants homes, measurements will be conducted over a period of 1 to 2 weeks while varying the physical interaction strategy (stroking) at sleep onset. Measured items: Childs acceleration (using Camntech Actiwatch), parental heart rate (using Toyobo smart-garment and Union Tool MyBeat), and sleep diaries. Psychological and Behavioral Assessment: Parental parenting stress (e.g., Edinburgh Postnatal Depression Scale) and the childs sensory characteristics (Sensory Profile) will be evaluated via anonymous questionnaires. In all measurements, the safety and psychological well-being of the target child will be the highest priority. Specific criteria will be established to immediately discontinue the session if intense crying or refusal persists.
Health Condition(s) Keyword		N/A
Intervention(s) Keyword		Physical contact, Biological sensing
Health Condition(s) Code		N/A
Intervention(s) Code		D014110, D010287
Primary Outcome(s)		Spontaneous physical activity, Heart rate variability (HRV), Sleep onset latency (SOL)
Secondary Outcome(s)		Infant vocalization (frequency, duration, etc.), Evaluation of child's sensory characteristics using the Sensory Profile

Primary Sponsor	none

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Ethics Committee in faculty of medicine Toho University
Address	5-21-16, Omori-nishi, Ota-ku, Tokyo, Japan, Tokyo
Telephone	+81-3-3762-4151
E-Mail	sachine.yoshida@med.toho-u.ac.jp
Approval Status	Approval
Date of approval	Feb. 26, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none