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

Email

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


Email

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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031556


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name