UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059771 |
|---|---|
| Receipt number | R000068344 |
| Scientific Title | Evaluation of Somatic-Visceral Reflexes Associated with Back Heat Therapy Using Bowel Sounds and Heart Rate Variability Analysis;A randomized controlled trial |
| Date of disclosure of the study information | 2025/11/20 |
| Last modified on | 2025/11/13 19:03:06 |
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Basic information
Public title
Evaluation of Somatic-Visceral Reflexes Associated with Back Heat Therapy Using Bowel Sounds and Heart Rate Variability Analysis;A randomized controlled trial
Acronym
Evaluation of Somatic-Visceral Reflexes Associated with Back Heat Therapy Using Bowel Sounds and Heart Rate Variability Analysis
Scientific Title
Evaluation of Somatic-Visceral Reflexes Associated with Back Heat Therapy Using Bowel Sounds and Heart Rate Variability Analysis;A randomized controlled trial
Scientific Title:Acronym
Evaluation of Somatic-Visceral Reflexes Associated with Back Heat Therapy Using Bowel Sounds and Heart Rate Variability Analysis
Region
| Japan |
Condition
Condition
Healthy adult women with constipation
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of Somatic-Visceral Reflexes Associated with Lumbar-Dorsal Heat Therapy Using Bowel Sounds and Heart Rate Variability (HRV) Analysis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
bowel sounds:An external microphone is attached to the left lower abdomen to collect bowel peristalsis.
Key secondary outcomes
Instantaneous heart rate is calculated from the R-R interval of the recorded ECG. In addition, Heart Rate Variability(HRV)analysis is performed as an indicator of cardiac autonomic function.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention group 1 (thoracic vertebrae group)
This group applies a warm compress for 10 minutes to the area 10 cm above the 12th thoracic vertebra.
Interventions/Control_2
Intervention group 2 (lumbar vertebrae group)
This group applies a warm compress for 10 minutes
to a 10 cm wide area centered on the Jacoby line(the line connecting the left and right iliac crests).
Interventions/Control_3
Intervention group 3 (sacrum group)
This group applies a warm compress for 10 minutes to the area corresponding to the height of the second sacral vertebra, within a range extending 10 cm below the line connecting the posterior superior iliac spines.
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
| 30 | years-old | > |
Gender
Female
Key inclusion criteria
Healthy women aged 18 to under 30 who are aware of constipation.
Key exclusion criteria
(1) Those who are in the hospital or receiving medication due to an underlying disease.
(2) Those with circulatory system abnormalities.
(3) Persons with bleeding tendency.
(4) Those with abnormalities in the skin of the lower back.
Target sample size
31
Research contact person
Name of lead principal investigator
| 1st name | Toshimi |
| Middle name | |
| Last name | Hiroi |
Organization
Takasaki University of Health and Welfare
Division name
Department of Nursing, Faculty of Health Care
Zip code
370-0033
Address
27 Nakaorui-Machi,Takasaki,Gunma
TEL
027-352-1291
hiroi-t@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshimi |
| Middle name | |
| Last name | Hiroi |
Organization
Takasaki University of Health and Welfare
Division name
Department of Nursing, Faculty of Health Care
Zip code
370-0033
Address
27 Nakaorui-Machi,Takasaki,Gunma
TEL
027-352-1291
Homepage URL
hiroi-t@takasaki-u.ac.jp
Sponsor or person
Institute
Takasaki University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research/MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Takasaki University of Health and Welfare Research Ethics Committee
Address
27 Nakaorui-Machi,Takasaki,Gunma
Tel
027-352-1291
mune@takasaki-u.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 | 11 | Month | 20 | 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
| 2025 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 27 | 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
| 2025 | Year | 11 | Month | 13 | Day |
Last modified on
| 2025 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068344
