UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053329 |
|---|---|
| Receipt number | R000060844 |
| Scientific Title | The Effects of Group Active Rest on Psychological Distress: A Single Arm Trial among Nurses |
| Date of disclosure of the study information | 2024/01/15 |
| Last modified on | 2025/05/27 14:49:28 |
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Basic information
Public title
Effects of workplace group exercise on psychological distress: A pretest-and-posttest study among nurses
Acronym
Effects of workplace group exercise on psychological distress: A pretest-and-posttest study among nurses
Scientific Title
The Effects of Group Active Rest on Psychological Distress: A Single Arm Trial among Nurses
Scientific Title:Acronym
The Effects of Group Active Rest on Psychological Distress
Region
| Japan |
Condition
Condition
Psychological distress
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the effects of workplace group active rest on psychological distress among nurses by single-arm trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Psychological distress
Key secondary outcomes
Workplace social capital
Somatic symptoms
Work performance
Participation rate
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
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Subjects participate in the workplace group active rest, consisting of stretching and strength training 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The inclusion criterion of this study is working as nurse.
Key exclusion criteria
The exclusion criteria of this study are as follows: 1) with pregnancy, 2) with a history of cardiovascular disease or severe illnesses, 3) suffering injuries to the neck, shoulders, arms, hands, or lower back, 4) with red flag signs of back pain and 5)with contraindications to exercise.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Kosuke |
| Middle name | |
| Last name | MAFUNE |
Organization
University of Occupational and Environmental Health, Japan
Division name
Department of Mental Health, Institute of Industrial Ecological Sciences
Zip code
807-8555
Address
1-1 Iseigaoka, Yahata-nishi, Kitakyushu, Fukuoka
TEL
093-603-1611
kosuke-mafune@umin.net
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | MAFUNE |
Organization
University of Occupational and Environmental Health, Japan
Division name
Department of Mental Health, Institute of Industrial Ecological Sciences
Zip code
807-8555
Address
1-1 Iseigaoka, Yahata-nishi, Kitakyushu, Fukuoka
TEL
093-603-1611
Homepage URL
kosuke-mafune@umin.net
Sponsor or person
Institute
University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
Funding Source
Organization
University of Occupational and Environmental Health, Japan
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Medical Research, University of Occupational and Environmental Health, Japan
Address
1-1 Iseigaoka, Yahata-nishi, Kitakyushu, Fukuoka
Tel
093-603-1611
daigakukanri@mbox.pub.uoeh-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
製鉄記念八幡病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | 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
79
Results
Under construction.
Results date posted
| 2025 | Year | 05 | Month | 27 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The website is under construction.
Date of the first journal publication of results
Baseline Characteristics
Age (mean(SD)): 37.2(10.3) yrs
male/female: 1/78
Affiliation: acute stage hospitals 2 workplaces
Long-Term Acute Care Hospital 2 workplaces
Participant flow
Recruitment was conducted at a meeting attended by the managerial and supervisory staff of all workplaces to which the potential participants belonged. Applications were received from 86 individuals across four workplaces. After seven individuals who met the exclusion criteria were excluded, 79 participants were included in the analysis.
Adverse events
Nothing
Outcome measures
K6 Japanese version
Workplace Social Capital Scale
Somatic Symptom Scale-8
WHO-HPQ
Adherence
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2024 | 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 | 01 | Month | 11 | Day |
Last modified on
| 2025 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060844
