UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056450 |
|---|---|
| Receipt number | R000064506 |
| Scientific Title | The effects of footbaths on patients with brain disorders who complain of difficulty falling asleep |
| Date of disclosure of the study information | 2024/12/16 |
| Last modified on | 2024/12/16 20:32:23 |
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Basic information
Public title
The effects of footbaths on patients with brain disorders who complain of difficulty falling asleep
Acronym
The effects of footbaths on patients with brain disorders who complain of difficulty falling asleep
Scientific Title
The effects of footbaths on patients with brain disorders who complain of difficulty falling asleep
Scientific Title:Acronym
The effects of footbaths on patients with brain disorders who complain of difficulty falling asleep
Region
| Japan |
Condition
Condition
Brain disease
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to implement a foot bath for patients with brain disorders who have difficulty falling asleep and to determine its effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Footbaths are carried out before bedtime, and the core body temperature is compared before and after the intervention.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Take a footbath before bed.
Interventions/Control_2
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those with sleep disorders with a PSQI score of 6 or more
Those who can provide written consent to participate in this study
Key exclusion criteria
Those with insomnia caused by systemic illnesses such as heart failure or respiratory failure, or mental illnesses such as depression or anxiety disorders.
Those suspected of having dementia with a score of 26 or less on the MMSE
Those with no wounds or inflammation on the skin of the foot bath area.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Sanae |
| Middle name | |
| Last name | Oriyama |
Organization
Hiroshima University Graduate School of Biomedical and Health Sciences
Division name
Division of Nursing Science
Zip code
734-8553
Address
Kasumi 1-2-3, Minami-ku, Hiroshima, Hiroshima, Japan
TEL
082-257-5355
oriyama@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Sanae |
| Middle name | |
| Last name | Oriyama |
Organization
Hiroshima University Graduate School of Biomedical and Health Sciences
Division name
Division of Nursing Science
Zip code
734-8553
Address
Kasumi 1-2-3, Minami-ku, Hiroshima, Hiroshima, Japan
TEL
082-257-5355
Homepage URL
oriyama@hiroshima
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
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
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3, Minami-ku, Hiroshima, Hiroshima, Japan
Tel
0822571551
iryo-sinsa@office.hiroshima-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
| 2024 | Year | 12 | Month | 16 | 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
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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 12 | Month | 13 | Day |
Last modified on
| 2024 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064506
