UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055734 |
|---|---|
| Receipt number | R000062308 |
| Scientific Title | Effects of different intervals and durations of lumbar hot compresses on constipation symptoms: a three-group randomized controlled trial |
| Date of disclosure of the study information | 2024/10/04 |
| Last modified on | 2025/12/29 11:24:30 |
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Basic information
Public title
Effects of different intervals and durations of lumbar hot compresses on constipation symptoms: a three-group randomized controlled trial
Acronym
Effects of different intervals and durations of lumbar hot compresses on constipation symptoms: a three-group randomized controlled trial
Scientific Title
Effects of different intervals and durations of lumbar hot compresses on constipation symptoms: a three-group randomized controlled trial
Scientific Title:Acronym
Effects of different intervals and durations of lumbar hot compresses on constipation symptoms: a three-group randomized controlled trial
Region
| Japan |
Condition
Condition
Adult women with constipation symptoms
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of different intervals and durations of lumbar hot compresses on constipation symptoms
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
Number of stools
Number of days with stools
Defecation pattern classification
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Apply a heat and steam generating sheet to the lumbar region daily
Interventions/Control_2
Apply a heat and steam generating sheet to the lumbar region three days a week
Interventions/Control_3
Do not apply a heat and steam generating sheet to the lumbar region
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
| 39 | years-old | >= |
Gender
Female
Key inclusion criteria
Women aged 18-39 years with a score of 5 or more on the long-term version of the Japanese version of the Constipation Rating Scale
Key exclusion criteria
(1) Unable to read or write Japanese.
(2) Apply warm compresses to the lower back and abdomen usually
(3) Diagnosed with organic defecation problems or constipation symptoms secondary to other diseases
(4) Does not own an information terminal device with internet access.
(5) Has an irregular lifestyle due to shift work, etc., which makes it difficult to apply a heat and steam generating sheet when waking up.
(6) Currently pregnant or possibly pregnant or breastfeeding.
(7) Have experienced skin problems with heat and steam generating sheets
Target sample size
105
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Katogi |
Organization
Kanagawa University of Human Services
Division name
School of Nursing, Faculty of Health and Social Services
Zip code
238-8522
Address
Heiseicho 1-10-1, Yokosuka City, Kanagawa
TEL
046-828-2500
katogi-pvh@kuhs.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Katogi |
Organization
Kanagawa University of Human Services
Division name
School of Nursing, Faculty of Health and Social Services
Zip code
238-8522
Address
Heiseicho 1-10-1, Yokosuka City, Kanagawa
TEL
046-828-2500
Homepage URL
katogi-pvh@kuhs.ac.jp
Sponsor or person
Institute
Kanagawa University of Human Services
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Nursing Art and Science
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
IRB in Kanagawa University of Human Services
Address
Heiseicho 1-10-1, Yokosuka City, Kanagawa
Tel
046-828-2907
jimu-rinri@kuhs.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 | 10 | Month | 04 | 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
59
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
Completed
Date of protocol fixation
| 2024 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 13 | 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 | 10 | Month | 03 | Day |
Last modified on
| 2025 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062308
