UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062450 |
|---|---|
| Receipt number | R000071475 |
| Scientific Title | Immediate Effects of a Warm Hand-Bath Intervention on Autonomic Nervous Activity and Prefrontal Hemodynamics in Patients With Depression: A Single-Arm Exploratory Interventional Study |
| Date of disclosure of the study information | 2026/08/04 |
| Last modified on | 2026/08/03 16:08:25 |
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Basic information
Public title
A Study of the Physical and Psychological Effects of Warm Hand Bathing in Patients With Depression
Acronym
Hand Bath for Depression Study
Scientific Title
Immediate Effects of a Warm Hand-Bath Intervention on Autonomic Nervous Activity and Prefrontal Hemodynamics in Patients With Depression: A Single-Arm Exploratory Interventional Study
Scientific Title:Acronym
Hand Bath Intervention for Depression Study HBID Study
Region
| Japan |
Condition
Condition
Depressive disorders
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to determine the immediate effects of a 5-minute warm hand-bath intervention using water at 39 degrees C on autonomic nervous activity and prefrontal hemodynamics in patients with depressive disorders. Changes in skin temperature and subjective mood states before and after the intervention will also be evaluated.
Basic objectives2
Others
Basic objectives -Others
Exploratory evaluation of physiological and psychological responses to a warm hand-bath intervention
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in prefrontal oxygenated hemoglobin (Oxy-Hb) concentration from the pre-intervention resting period to the hand-bath intervention period
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
Each participant will receive a single 5 minute warm hand bath. Both hands and forearms will be immersed up to the radial styloid level in water maintained at 39 degrees C. Participants will rest for 2 minutes before and 3 minutes after the intervention.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inpatients aged 18 years or older in the psychiatric ward of Asahi General Hospital
Individuals who hold a Mental Disability Certificate at Grade 2 or Grade 3
Individuals who have the capacity to make an independent decision regarding study participation
Individuals judged by the attending psychiatrist to be able to participate in the study
Individuals who receive a written explanation of the study and voluntarily provide written informed consent
Key exclusion criteria
Patients with severe acute psychiatric symptoms who are unable to remain at rest or cooperate with the measurements, as judged by the attending psychiatrist
Patients with severe physical conditions for whom thermal stimulation cannot be safely performed, including severe cardiac disease or peripheral circulatory disorders
Patients with infection, injury, eczema, or other skin lesions on the forearms that make hand bathing inappropriate
Patients expected to have severe anxiety or agitation that would make it difficult to tolerate the equipment or study procedures
Patients judged ineligible by the attending psychiatrist or the principal investigator
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | hajime |
| Middle name | |
| Last name | nakano |
Organization
Josai International University
Division name
Department of Nursing, Faculty of Health Sciences
Zip code
283-8555
Address
1 Gumyo, Togane, Chiba 283-8555, Japan
TEL
0475-55-8811
hanakano@jiu.ac.jp
Public contact
Name of contact person
| 1st name | hajime |
| Middle name | |
| Last name | nakano |
Organization
Josai International University
Division name
Department of Nursing, Faculty of Health Sciences
Zip code
283-8555
Address
1 Gumyo, Togane, Chiba 283-8555, Japan
TEL
0475-55-8800
Homepage URL
hanakano@jiu.ac.jp
Sponsor or person
Institute
Josai International University
Institute
Department
Personal name
Funding Source
Organization
Josai International University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Josai International University Ethics Committee for Research Involving Human Subjects
Address
Research Promotion Office, Josai International University, 1 Gumyo, Togane, Chiba 283-8555, Japan
Tel
0475-55-7832
research-c@jiu.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
| 2026 | Year | 08 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2026 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2028 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 03 | Day |
Last modified on
| 2026 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071475
