UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054444 |
|---|---|
| Receipt number | R000062192 |
| Scientific Title | Identification of characteristics of sighing through comparative study of breathing methods |
| Date of disclosure of the study information | 2024/05/21 |
| Last modified on | 2025/12/08 11:08:38 |
* 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
Identification of characteristics of sighing through comparative study of breathing methods
Acronym
Identification of characteristics of sighing through comparative study of breathing methods
Scientific Title
Identification of characteristics of sighing through comparative study of breathing methods
Scientific Title:Acronym
Identification of characteristics of sighing through comparative study of breathing methods
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the characteristics of sighing from a morphological and functional perspective by comparing and analyzing each breathing method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart rate variability, respiratory waveform
Key secondary outcomes
STAXI, STAXI-2
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Breathing methods(base line, usual deep breathing, instructed deep breathing, sigh of relief, sigh of discomfort).
Interventions/Control_2
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults, men and women aged 18 to under 40, with a BMI of 18.5 to under 25
Key exclusion criteria
History of smoking (more than 3 years), history of respiratory disease/circulatory system disease and its sequelae, history of mental illness, episode of hyperventilation attack, taking medication, high blood pressure based on the "Hypertension Treatment Guidelines 2014" allergies or dermatitis
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yumiko |
| Middle name | |
| Last name | Yoshino |
Organization
Shonan Kamakura University of Medical Sciences
Division name
Faculty of Nursing
Zip code
247-0066
Address
1195-3 Yamasaki,Kamakura,Kanagawa
TEL
0467-38-3131
y.yoshino@sku.ac.jp
Public contact
Name of contact person
| 1st name | Yumiko |
| Middle name | |
| Last name | Yoshino |
Organization
Shonan Kamakura University of Medical Sciences
Division name
Faculty of Nursing
Zip code
247-0066
Address
1195-3 Yamasaki,Kamakura,Kanagawa
TEL
0467-38-3131
Homepage URL
y.yoshino@sku.ac.jp
Sponsor or person
Institute
Shonan Kamakura University of Medical Sciences
Institute
Department
Personal name
Yumiko Yoshino
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shonan Kamakura University of Medical Sciences
Address
1195-3 Yamasaki,Kamakura,Kanagawa
Tel
0467-38-3131
soumu@sku.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 | 05 | Month | 21 | 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
12
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 05 | Month | 21 | Day |
Last modified on
| 2025 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062192
