UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035647 |
|---|---|
| Receipt number | R000040607 |
| Scientific Title | A Study on Intervention of Simplified Progressive Muscle Relaxation Method for Insomnia in Cancer Patients |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2024/01/29 08:31:53 |
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Basic information
Public title
A Study on Intervention of Simplified Progressive Muscle Relaxation Method for Insomnia in Cancer Patients
Acronym
A Study on Intervention of Simplified Progressive Muscle Relaxation Method for Insomnia in Cancer Patients
Scientific Title
A Study on Intervention of Simplified Progressive Muscle Relaxation Method for Insomnia in Cancer Patients
Scientific Title:Acronym
A Study on Intervention of Simplified Progressive Muscle Relaxation Method for Insomnia in Cancer Patients
Region
| Japan |
Condition
Condition
cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of simplified progressive muscle relaxation method on insomnia of cancer patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Actigraph
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Simplified Progressive Muscle Relaxation
Interventions/Control_2
control
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Diagnosis is cancer
Symptoms of insomnia exist
Symptoms is stable
No history of mental illness
Key exclusion criteria
It is other than selection criteria
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | kondo |
Organization
Gunma University
Division name
Graduate school
Zip code
371-8514
Address
Maebashi Gunma
TEL
0272208982
yukondo@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Kondo |
Organization
Gunma University
Division name
Graduate school
Zip code
371-8514
Address
Maebashi Gunma
TEL
0272208982
Homepage URL
yukondo@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
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
Gunma University
Address
Showa-machi,Maebashi,Gunma
Tel
0272207111
yukondo@gunma-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
| 2019 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
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
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2023 | 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
| 2019 | Year | 01 | Month | 23 | Day |
Last modified on
| 2024 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040607
