UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027525 |
|---|---|
| Receipt number | R000031556 |
| Scientific Title | Effect of Hand Bath and Massage on Sleep in Elderly with Modulation on Sleep-Wake Rhythm. |
| Date of disclosure of the study information | 2017/09/04 |
| Last modified on | 2019/05/30 09:42:42 |
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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
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
yukiko@hs.akita-u.ac.jp
Public contact
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
yukiko@hs.akita-u.ac.jp
Sponsor or person
Institute
Akita University Graduate School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031556
