UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044465 |
|---|---|
| Receipt number | R000050676 |
| Scientific Title | The effects of yoga therapy on burnout among medical staff: a single-arm pre-post intervention |
| Date of disclosure of the study information | 2021/06/15 |
| Last modified on | 2023/06/10 22:25:30 |
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Basic information
Public title
The effects of yoga therapy on burnout among medical staff
Acronym
The effects of yoga therapy on burnout among medical staff
Scientific Title
The effects of yoga therapy on burnout among medical staff: a single-arm pre-post intervention
Scientific Title:Acronym
The effects of yoga therapy on burnout among medical staff: a single-arm pre-post intervention
Region
| Japan |
Condition
Condition
Medical staff
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of yoga therapy on burn-out among medical staff.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of participants, completion rate,
Client Satisfaction Questionnaire 8
Key secondary outcomes
Maslach Burnout Inventory General Survey(MBI-GS), Patient Health Questionnaire-9(PHQ-9), blood pressure, heart rate variability, alpha-amylase activities,
General Anxiety Disorders-7(GAD-7), Pittsburgh Sleep Quality Index(PSQI), EuroQol-5 dimensions classification system(EQ-5D), Sheehan Disability Scale(SDS), Resilience Scale(RS).
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
All participants will take a 2-week yoga intervention(twice a week, 60-min session/per). The module on yoga therapy will contain warm-up, meditation, yoga poses, and breathing exercises. Each yoga session will be conducted with both in-person and online intervention. During the study, the prescription among each participant will be sustained.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.medical staff who work at Tokyo Dental College Ichikawa General Hospital,
2.male and female, more than 20 years old,
3.Capability of informed consent
Key exclusion criteria
1. staff who is the inability to exercise(ex, infection diseases and injuries)
2.staff who has a lower level of MBI-GS score(lower than 1.0 of cynicism and fatigue)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Saeko |
| Middle name | |
| Last name | Ikai-Tani |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
1608582
Address
35, Shinanomachi, Shinjuku-ku, Tokyo,Japan.
TEL
+81.3.5363.3829
sako0609@gmail.com
Public contact
Name of contact person
| 1st name | Saki |
| Middle name | |
| Last name | Kamiyama |
Organization
Tokyo Dental College
Division name
Department of Psychiatry
Zip code
2728513
Address
5-11-13, Sugano, Ichikawa, Chiba, Japan
TEL
+81.47.322.0151
Homepage URL
sako0609@gmail.com
Sponsor or person
Institute
Department of Psychiatry, Tokyo Dental College
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science, the Grant-in-Aid for Young Scientists
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
Tokyo Dental College Institutional Review Boards
Address
5-11-13, Sugano, Ichikawa, Chiba, Japan
Tel
+81.647.322.0151
yogaresearchjapan@gmail.com
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
| 2021 | Year | 06 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
With reapproval from the Ethics Committee, the sample size could be increased to 50.
Management information
Registered date
| 2021 | Year | 06 | Month | 08 | Day |
Last modified on
| 2023 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050676
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
