UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Hand Bath and Massage on Sleep in Elderly with Modulation on Sleep-Wake Rhythm.
Acronym	Effect of Hand Bath and Massage on Sleep in Elderly with Modulation on Sleep-Wake Rhythm.
Scientific Title	Effect of Hand Bath and Massage on Sleep in Elderly with Modulation on Sleep-Wake Rhythm.
Scientific Title:Acronym	Effect of Hand Bath and Massage on Sleep in Elderly with Modulation on Sleep-Wake Rhythm.
Region	Japan

Condition
Condition	Elderly
Classification by specialty	Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims is conducted to clarify the effects of a hand bath and massage on sleep, autonomic nervous activity and subjective comfort in elderly with modulation on sleep-wake rhythm.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sleep latency, total sleep time, total arousal time, sleep efficiency, sleep episode, arousal episode, heart rate, SDNN, RMMSD, HF, LF / HF and subjective sleep questionnaire.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Hand bath after 5 minutes, then 20 minutes hand massage.
Interventions/Control_2	Control.
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Participants with subjective symptoms of sleep such as not fall asleep, awake at night, drowsy during the day.
Key exclusion criteria	None.
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Yukiko Middle name Last name KUDO
Organization	Akita University Graduate School
Division name	Health Sciences
Zip code	0108543
Address	1-1-1, Hondo, Akita
TEL	018-884-6505
Email	yukiko@hs.akita-u.ac.jp

Public contact
1st name of contact person	1st name Yukiko Middle name Last name KUDO
Organization	Akita University Graduate School
Division name	Health Sciences
Zip code	0108543
Address	1-1-1, Hondo, Akita
TEL	018-884-6505
Homepage URL
Email	yukiko@hs.akita-u.ac.jp

Sponsor
Institute	Akita University Graduate School
Institute
Department

Funding Source
Organization	The Japanese Ministry of Education, Culture, Sports, Science, and Technology.
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Independent Ethics Committee at Akita University Graduate School of Medicine
Address	1-1-1, Hondo, Akita
Tel	018-884-6028
Email	soken@hos.akita-u.ac.jp

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

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 04 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	28
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	Completed
Date of protocol fixation	2017 Year 07 Month 31 Day
Date of IRB	2017 Year 05 Month 22 Day
Anticipated trial start date	2017 Year 09 Month 04 Day
Last follow-up date	2020 Year 03 Month 31 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 05 Month 29 Day
Last modified on	2019 Year 05 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031556