UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000058044 |
|---|---|
| Receipt number | R000066341 |
| Scientific Title | Feasibility of the heaviness perception test as an assessment of interoception: Physiological approach employing heart rate variability biofeedback |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/06/02 07:56:53 |
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Basic information
Public title
Studying Inner Body Sensations Through Weight: Focusing on the Mind-Body Connection
Acronym
Listening to Your Body Through Weight
Scientific Title
Feasibility of the heaviness perception test as an assessment of interoception: Physiological approach employing heart rate variability biofeedback
Scientific Title:Acronym
An Exploratory Study on Interoceptive Assessment Using heaviness: A Physiological Approach with HRV Biofeedback
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the utility of the heaviness perception test in assessing interoception, with a view to its future application in young children. To achieve this, we will examine changes in test performance before and after heart rate variability biofeedback (HRVB) intervention in healthy university students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
the heaviness perception test: Before and After HRV Biofeedback
Key secondary outcomes
Electrocardiogram and respiratory data
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
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Heart Rate Variability Biofeedback (HRVB): HRVB is a technique that provides feedback on heart rate variability (HRV) and guides individuals to enhance this variability. It generally involves breathing at a paced rhythm of approximately 10 seconds per cycle (0.1 Hz). The intervention will be conducted only once and will last for 20 minutes.
Interventions/Control_2
Normal Breathing (Control): In the condition involving paced breathing at a frequency of 0.25 Hz, a pacemaker guides participants to inhale for 2 seconds and exhale for 2 seconds.
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
| 18 | years-old | <= |
Age-upper limit
| 22 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria are that, on the day of the study, participants have no musculoskeletal, respiratory, or cardiovascular disorders affecting the upper limbs and are not taking any medications.
Key exclusion criteria
The exclusion criteria are the presence of musculoskeletal, respiratory, or cardiovascular disorders affecting the upper limbs, or the use of any medications on the day of the study.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Fujimoto |
Organization
Aichi Medical College for Physical and Occupational Therapy
Division name
Physical Therapy Major
Zip code
4520931
Address
519 Ichiba, Kiyosu City, Aichi Prefecture
TEL
+81-52-409-3311
fujimoto@yuai.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Fujimoto |
Organization
Aichi Medical College for Physical and Occupational Therapy
Division name
Physical Therapy Major
Zip code
4520931
Address
519 Ichiba, Kiyosu City, Aichi Prefecture
TEL
+81-52-409-3311
Homepage URL
fujimoto@yuai.ac.jp
Sponsor or person
Institute
Aichi Medical College for Physical and Occupational Therapy
Institute
Department
Personal name
Daisuke Fujimoto
Funding Source
Organization
Aichi Medical College for Physical and Occupational Therapy
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Aichi Medical College for Physical and Occupational Therapy
Address
519 Ichiba, Kiyosu City, Aichi Prefecture
Tel
052-409-3311
fujimoto@yuai.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
愛知県
Institutions
Institutions
愛知医療学院短期大学（愛知県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | 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
| 2025 | Year | 06 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | 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 | 06 | Month | 02 | Day |
Last modified on
| 2025 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066341
