UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056463 |
|---|---|
| Receipt number | R000064521 |
| Scientific Title | Effect of anger control using sighing in medical professionals |
| Date of disclosure of the study information | 2025/01/20 |
| Last modified on | 2024/12/15 14:59:21 |
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Basic information
Public title
Effect of anger control using sighing in medical professionals
Acronym
Effect of anger control using sighing in medical professionals
Scientific Title
Effect of anger control using sighing in medical professionals
Scientific Title:Acronym
Effect of anger control using sighing in medical professionals
Region
| Japan |
Condition
Condition
healty adults
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to deal with anger among medical professionals, we will empirically verify the effectiveness of anger management for medical professionals from both the physical and mental perspectives by grasping anger characteristics using STAXI-2 from a psychological perspective and utilizing the adaptive effects of sigh breathing techniques from a physical perspective.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
The psychological aspects are the Japanese version of STA|XI-2, K6, and the Japanese version of the abbreviated version of POMS2.
The physiological aspects are heart rate variability and respiratory waveforms.
Instruction is given, followed by self-practice for five days, after which the effects are measured.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Understanding anger characteristics using the Japanese version of staxi-2 and practicing sigh breathing exercises
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
registered nurse
Key exclusion criteria
Exclusion criteria were: episodes of hyperventilation attacks, respiratory or circulatory symptoms on the day of the study, or hypertension based on the 2014 Hypertension Treatment Guidelines (systolic blood pressure/diastolic blood pressure 140mmHg/90mmHg or both).
Target sample size
12
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
2470066
Address
1195-3 Yamasaki Kamakura kanagawa Japan
TEL
0467383131
y.yoshino@sku.ac.jp
Public contact
Name of contact person
| 1st name | YUMI |
| Middle name | |
| Last name | YOSHINO |
Organization
SHONAN KAMAKURA UNIVERSITY OF MEDICAL SCIENCES
Division name
Faculty of Nursing
Zip code
2470066
Address
1195-3 Yamasaki Kamakura kanagawa Japan
TEL
0467383131
Homepage URL
y.yoshino@sku.ac.jp
Sponsor or person
Institute
SHONAN KAMAKURA UNIVERSITY OF MEDICAL SCIENCES
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
SHONAN KAMAKURA UNIVERSITY OF MEDICAL SCIENCES
Address
1195-3 Yamasaki Kamakura kanagawa Japan
Tel
0467383131
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
| 2025 | Year | 01 | 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
| 2024 | Year | 12 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 08 | 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 | 12 | Month | 15 | Day |
Last modified on
| 2024 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064521
