UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062339 |
|---|---|
| Receipt number | R000071336 |
| Scientific Title | Distribution of Pain by Anatomical Site and the Impact of Pain Categories on Physical Function, Quality of Life, and Depression in Older Patients With Heart Failure Hospitalized in Acute Care Hospitals: A Multicenter Cross-Sectional Study |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/07/26 08:10:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Distribution of Pain by Anatomical Site and the Impact of Pain Categories on Physical Function, Quality of Life, and Depression in Older Patients With Heart Failure Hospitalized in Acute Care Hospitals: A Multicenter Cross-Sectional Study
Acronym
IYO-PAIN AHF study
Scientific Title
Distribution of Pain by Anatomical Site and the Impact of Pain Categories on Physical Function, Quality of Life, and Depression in Older Patients With Heart Failure Hospitalized in Acute Care Hospitals: A Multicenter Cross-Sectional Study
Scientific Title:Acronym
IYO-PAIN AHF study
Region
| Japan |
Condition
Condition
Heart failure (acute heart failure and acute decompensation of chronic heart failure)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to clarify the distribution of pain sites and pain categories (no pain, single-site pain, and multisite pain) before discharge in older patients hospitalized with heart failure in acute care hospitals. The secondary objective is to examine the associations between pain categories and physical function (SPPB), quality of life (EQ-5D-5L), and depression (HADS-D).
Basic objectives2
Others
Basic objectives -Others
This is an observational study aiming to clarify the distribution of pain sites and the association between pain categories and physical function, QOL, and depression; it is not a trial designed to evaluate safety or efficacy, hence 'Others' was selected.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of pain by body site, assessed before discharge.
Key secondary outcomes
Total SPPB score, EQ-5D-5L index value, total HADS-D score, number of pain sites, and pain category (no pain, single-site pain, multisite pain), assessed before discharge.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Age 65 years or older.
Hospitalized for acute heart failure or acute decompensation of chronic heart failure.
Only the first hospitalization during the study period is registered.
Key exclusion criteria
Patients who died during hospitalization.
Patients with severe cognitive impairment.
Patients unable to complete questionnaires due to delirium etc.
Terminally ill patients.
Patients for whom physical function assessment is not feasible.
Patients with persistent severe chest pain or hemodynamic instability making safe assessment difficult.
Cases judged inappropriate for inclusion by the principal investigator.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Tomonari |
| Middle name | |
| Last name | Okada |
Organization
Yawatahama City General Hospital
Division name
Department of Rehabilitation
Zip code
796-8502
Address
638 Ohira 1-bankochi, Yawatahama, Ehime
TEL
0894-22-3211
okadaokadasya@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tomonari |
| Middle name | |
| Last name | Okada |
Organization
Yawatahama City General Hospital
Division name
Department of Rehabilitation
Zip code
796-8502
Address
638 Ohira 1-bankochi, Yawatahama, Ehime
TEL
0894-22-3211
Homepage URL
okadaokadasya@yahoo.co.jp
Sponsor or person
Institute
Yawatahama City General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Uwajima City Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yawatahama City General Hospital
Address
638 Ohira 1-bankochi, Yawatahama, Ehime
Tel
0894-22-3211
okadaokadasya@yahoo.co.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 | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 07 | Month | 26 | Day |
Last modified on
| 2026 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071336
