UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058689 |
|---|---|
| Receipt number | R000067028 |
| Scientific Title | Development of new intervention methods to reduce stress and improve autonomic nervous function in nurses |
| Date of disclosure of the study information | 2025/08/04 |
| Last modified on | 2025/08/06 16:10:21 |
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Basic information
Public title
Development of new intervention methods to reduce stress and improve autonomic nervous function in nurses
Acronym
Development of new intervention methods to reduce stress and improve autonomic nervous function in nurses
Scientific Title
Development of new intervention methods to reduce stress and improve autonomic nervous function in nurses
Scientific Title:Acronym
Development of new intervention methods to reduce stress and improve autonomic nervous function in nurses
Region
| Japan |
Condition
Condition
Female nurses working in shifts
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to reduce stress among nurses working in shifts. We will clarify the current state of stress and autonomic nervous function in nurses who work in shifts, and further clarify whether heart rate variability biofeedback is effective in reducing stress and activating the parasympathetic nervous system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whether or not there is a decrease in the expression of stress-related salivary proteins in the intervention group using ELIZA.
Key secondary outcomes
Whether stress-related psychological scores decreased in the intervention group.
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
| Behavior,custom |
Interventions/Control_1
After instructing the intervention group on how to use the heart rate variability biofeedback device, the device will be loaned to them, and they will perform heart rate variability biofeedback at home for a period of four weeks.
Interventions/Control_2
The control group did not receive heart rate variability biofeedback intervention and continued their normal lifestyles.
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
| 22 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
1. Individuals who can obtain written consent from the individual to participate in the study of their own free will.
2. Female nurses working shifts at a general hospital.
3. Individuals under the age of 40.
4. Individuals who own an iPhone or Android smartphone.
Key exclusion criteria
1. First-year graduates
2. BMI of 30 or higher
3. Those currently undergoing treatment for a medical or mental illness
4. Pregnant women
5. Others who the principal investigator or co-investigators deem inappropriate as research subjects
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | YUKA |
| Middle name | |
| Last name | KUMAGAI |
Organization
Akita University
Division name
Graduate School of Medicine and Faculty of Medicine
Zip code
010-8543
Address
1-1-1, Hondo, Akita City, Akita
TEL
018-884-6500
yukaku3@hs.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | YUKA |
| Middle name | |
| Last name | KUMAGAI |
Organization
Akita University
Division name
Graduate School of Medicine and Faculty of Medicine
Zip code
010-8543
Address
1-1-1, Hondo, Akita City, Akita
TEL
018-884-6500
Homepage URL
yukaku3@hs.akita-u.ac.jp
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
Funding Source
Organization
Akita University
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
Akita University Graduate School of Medicine and Faculty of Medicine Ethics Committee
Address
1-1-1, Hondo, Akita City, Akita
Tel
018-884-6500
yukaku3@s.akita-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 | 08 | 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
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 | 05 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 10 | 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 | 08 | Month | 04 | Day |
Last modified on
| 2025 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067028
