臨床研究等提出・公開システム

Scientific Title	A randomized crossover trial of sensory modulation intervention using a weighted blanket on autonomic function and subjective mood states in patients with schizophrenia
Public Title	Effects of a weighted blanket on autonomic nervous function and subjective mood in patients with schizophrenia

Contact for Scientific Queries	Name	Ueda Kenta
	Affiliation	Osaka psychatric medical center
	Address	3-16-21, Miyanosaka, Hirakata Shi, Osaka Fu
	Telephone	+81-72-847-3261
	E-mail	uedakenta@outlook.com
Contact for Public Queries	Name	Ueda Kenta
	Affiliation	Osaka psychatric medical center
	Address	3-16-21, Miyanosaka, Hirakata Shi, Osaka Fu
	Telephone	+81-72-847-3261
	E-mail	uedakenta@outlook.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Oct. 30, 2024
Actual date of first enrollment		Oct. 30, 2024
Target sample size		50
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	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Diagnosis is F2 (schizophrenia, schizotypal disorder, or delusional disorder) based on ICD-10. Continuously receiving outpatient occupational therapy or day care for at least six months.
	Exclusion Criteria	Possible pregnancy Consent to participate in the research was not obtained
	Age Minimum	20age old over
	Age Maximum	60age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Schizophrenia, Schizoaffective disorder, Delusional disorder
Intervention(s)		The subject selects the weight of the weighted blanket to be used (5 kg, 6 kg, or 7 kg) within the range of 5 to 10% of the subject's body weight. Afterwards, the subject lies supine on the bed with their eyes closed and rests for 15 minutes using the weighted blanket.
Intervention(s) Keyword		weighted blanket
Health Condition(s) Code		D012559
Primary Outcome(s)		Heart rate variability
Secondary Outcome(s)		STAI, Inventory Scale for Mood and Sense of Fatigue

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Osaka Psychiatric Medical Center
Address	3-16-21, Miyanosaka, Hirakata Shi, Osaka Fu, Osaka
Telephone	+81-72-847-3261
E-Mail	seishin-iryo@opho.jp
Approval Status	Approval
Date of approval	Aug. 20, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none