臨床研究等提出・公開システム

Date of registration	June. 13, 2024
Last modified on	June. 13, 2024
Trial ID	jRCT1030240162

Scientific Title	Study on Melatonin Secretion Enhancement by Tactile Massage with Normal and Thermal Rollers
Public Title	Tactile Massage to Stimulate Melatonin Secretion

Contact for Scientific Queries	Name	Hattori Atsuhiko
	Affiliation	Rikkyo University
	Address	1-2-26 Kitano, Niizashi, Saitama
	Telephone	+81-48-471-7335
	E-mail	ahattori1005@rikkyo.ac.jp
Contact for Public Queries	Name	Maruyama Yusuke
	Affiliation	Rikkyo University
	Address	1-2-26 Kitano, Niizashi, Saitama
	Telephone	+81-48-471-6710
	E-mail	ymaruyama@rikkyo.ac.jp

Recruitment status	Pending

Anticipated date of first enrollment		June. 13, 2024
Target sample size		20
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	crossover assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	(i) Persons who are at least 18 years of age at the time of obtaining consent. (ii) Persons who understand the content of this study and are able to obtain written consent.
	Exclusion Criteria	(i) Those who cannot give consent for this study. (ii) Those who responded on the consent form that their sleep onset time fluctuates more than 4 hours due to nighttime activities such as part-time jobs at least 3 times a week. (iii) Those who answered on the consent form that they are taking sleeping pills or heart medication (beta blockers) on a regular basis.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Healthy person Expected effect: Improvement of sleep quality
Intervention(s)		Participants are asked to roll the upper neck for 30 minutes before bedtime using a regular roller with pressure stimulati or a warm roller heated to 37 degrees Celsius.
Intervention(s) Keyword		Tactile Massage
Primary Outcome(s)		Urinary melatonin metabolites
Secondary Outcome(s)		Sleep duration

Primary Sponsor	Rikkyo University

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Secretariat of the Ethics and Safety Committee for Research and Experiments Related to Life Sciences, Rikkyo University
Address	3-34-1 Nishi-Ikebukuro, Toshima-ku, Tokyo, Tokyo
Telephone	+81-3-3985-4674
E-Mail	lifescience@rikkyo.ac.jp
Approval Status	Approval
Date of approval	May. 24, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none