UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061468 |
|---|---|
| Receipt number | R000069967 |
| Scientific Title | The effect of abdominal hot compress on constipation in Parkinson's disease patients: A randomized controlled trial |
| Date of disclosure of the study information | 2026/05/07 |
| Last modified on | 2026/05/07 11:26:19 |
* 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
The effect of abdominal hot compress on constipation in Parkinson's disease patients: A randomized controlled trial
Acronym
The effect of abdominal hot compress on constipation in Parkinson's disease patients: A randomized controlled trial
Scientific Title
The effect of abdominal hot compress on constipation in Parkinson's disease patients: A randomized controlled trial
Scientific Title:Acronym
The effect of abdominal hot compress on constipation in Parkinson's disease patients: A randomized controlled trial
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to clarify, through a randomized controlled trial, whether abdominal hot compress intervention once a day for one week has the effect of alleviating constipation symptoms in Parkinson's disease (PD) patients with constipation. A secondary objective is to evaluate the impact of this intervention on quality of life (QOL).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome: Total score of the Japanese version of the Constipation Assessment Scale-Middle Term (CAS-MT)
Time points of primary outcomes: Day 7 of the non-intervention period and day 7 of the intervention period
Key secondary outcomes
1) Scores of the 8 individual items of the CAS-MT
Time points: Day 7 of the non-intervention period and day 7 of the intervention period
2) Health-related quality of life (Japanese EQ-5D-5L)
Time points: Day 7 of the non-intervention period and day 7 of the intervention period
3) Defecation status (frequency/days, amount, stool form [Bristol Stool Form Scale], laxative use, manual disimpaction)
Time points: Recorded continuously throughout the non-intervention and intervention periods
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
In addition to usual care, apply a steam generating heat sheet to the abdomen for 5 hours once daily for one week.
Interventions/Control_2
Receive only usual care without the application of a steam generating heat sheet.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(Eligibility summary)
Inpatients diagnosed with Parkinson's disease, who have sufficient cognitive function for study participation, and whose general condition is judged as stable by their primary physician.
(Inclusion criteria)
1. Patients currently taking medication for constipation.
2. Patients with a total score of 1 or higher on the Japanese version of the Constipation Assessment Scale-LT (CAS-LT).
3. Patients at Hoehn and Yahr stages I to IV.
4. Patients aged between 65 and 84 years.
Key exclusion criteria
1. Patients with an MMSE score of 23/30 or less (based on data within the past 6 months from the time of registration).
2. Patients with a history of abdominal surgery.
3. Patients with diseases or symptoms that could be worsened by heat stimulation (e.g., multiple sclerosis, skin diseases), as judged by the primary physician.
4. Other patients judged by the physician to be inappropriate for participation in the study.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Kensuke |
| Middle name | |
| Last name | Miyawaki |
Organization
Japanese Red Cross Hiroshima College of Nursing
Division name
Graduate School Doctoral Program
Zip code
738-0052
Address
1-2, Ajinadaihigashi, Hatsukaichi City, Hiroshima Prefecture
TEL
0829-20-2800
k24d1007@jrchcn.ac.jp
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Miyawaki |
Organization
Japanese Red Cross Hiroshima College of Nursing
Division name
Graduate School Doctoral Program
Zip code
738-0052
Address
1-2, Ajinadaihigashi, Hatsukaichi City, Hiroshima Prefecture
TEL
0829-20-2800
Homepage URL
k24d1007@jrchcn.ac.jp
Sponsor or person
Institute
Japanese Red Cross Hiroshima College of Nursing
Institute
Department
Personal name
Kensuke Miyawaki
Funding Source
Organization
KIMURA FOUNDATION FOR NURSING EDUCATION
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, The Japanese Red Cross Hiroshima College of Nursing
Address
1-2, Ajinadaihigashi, Hatsukaichi City, Hiroshima Prefecture
Tel
0829-20-2800
sohmu@jrchcn.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 | 05 | Month | 07 | 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 | 02 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 05 | Month | 07 | Day |
Last modified on
| 2026 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069967
