UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056641 |
|---|---|
| Receipt number | R000064735 |
| Scientific Title | The effect of abdominal hot compress on constipation in parkinson's disease patients: a randomized controlled pilot study |
| Date of disclosure of the study information | 2025/01/16 |
| Last modified on | 2025/01/11 12:12:33 |
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Basic information
Public title
The effect of abdominal hot compress on constipation in parkinson's disease patients: a randomized controlled pilot study
Acronym
The effect of abdominal hot compress on constipation in parkinson's disease patients: a randomized controlled pilot study
Scientific Title
The effect of abdominal hot compress on constipation in parkinson's disease patients: a randomized controlled pilot study
Scientific Title:Acronym
The effect of abdominal hot compress on constipation in parkinson's disease patients: a randomized controlled pilot study
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This pilot study aims to investigate the effects of abdominal hot compress on constipation symptoms and quality of life in Parkinson's disease patients, as well as to examine the intervention content and evaluation methods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Japanese version of the Constipation Assessment Scale-Middle Term
Key secondary outcomes
Frequency of bowel movements
Stool consistency (Bristol Stool Scale)
Stool Volume
Type and usage of medications for constipation
Manual removal of stool
Fluid intake
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Applying a heat steam generationg sheet to the abdomen daily for a week
Interventions/Control_2
Do not apply a heat and steam generating sheet to the abdomen
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
Hospitalized patients diagnosed with Parkinson's disease who have been hospitalized for at least 3 days and whose condition is deemed stable by the attending physician. Additionally, participants must be taking laxatives, have a Constipation Assessment Scale-Middle Term version total score of 5 or more, be at Hoehn and Yahr stages I-IV of Parkinson's disease, and be aged between 65 and 85 years.
Key exclusion criteria
(1)Patients with a Mini Mental State Examination Japanese score of 23 or less.
(2)History of abdominal surgery.
(3)The following conditions require confirmation from the attending physician
Bleeding tendency, Severe general weakness, Severe blood pressure fluctuations, Fragile skin, Disturbance of consciousness or sensation, Diseases or symptoms that are considered to be aggravated by heat stimulation(multiple sclerosis, heat urticaria, atopic dermatitis, and lymphedema)
(4)Other cases where the attending physician judges that exclusion is necessary
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Miyawaki |
| Middle name | |
| Last name | Kensuke |
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 | Miyawaki |
| Middle name | |
| Last name | Kensuke |
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
Funding Source
Organization
Without
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Red Cross Hiroshima College of Nursing
Address
1-2, Ajinadaihigashi, Hatsukaichi City, Hiroshima Prefecture
Tel
0829-20-2800
k24d1007@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
| 2025 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2025 | 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
| 2025 | Year | 01 | Month | 06 | Day |
Last modified on
| 2025 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064735
