UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038226 |
|---|---|
| Receipt number | R000043443 |
| Scientific Title | Examination of postural drainage for patients with neuromuscular disease who cannot turn over by themselves and require sputum suction |
| Date of disclosure of the study information | 2019/10/07 |
| Last modified on | 2022/01/09 00:19:23 |
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Basic information
Public title
Examination of postural drainage for patients with neuromuscular disease who cannot turn over by themselves and require sputum suction
Acronym
Examination of postural drainage for patients with neuromuscular disease
Scientific Title
Examination of postural drainage for patients with neuromuscular disease who cannot turn over by themselves and require sputum suction
Scientific Title:Acronym
Examination of postural drainage for patients with neuromuscular disease
Region
| Japan |
Condition
Condition
Neuromuscular disease
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of postural drainage on neuromuscular patients and the factors that hinder their implementation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Numerical Rating Scale
Faces Pain Scale
Client Satisfaction Questionnaire
Treatment Self-Regulation Questionnaire
Free speech
Key secondary outcomes
Vital signs
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
| Maneuver |
Interventions/Control_1
1. Collection of patient information
2. Measure vital signs (3 minutes)
3. Get consent (10 minutes)
4. Use Questionnaire 1 to conduct an interview (5 minutes)
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patient in Kyusyu University Hospital.
2. Patients who are over 20 years old and have been diagnosed with neuromuscular disease or suspected of having the disease
3. Patients who require sputum suction.
4. Patients who cannot turn over by themselves.
5. Patients who are conscious and can communicate in some way.
6. Patients approved by the researcher's doctor.
Key exclusion criteria
-
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Watanabe |
Organization
Kyushu University Hospital
Division name
Nursing Department
Zip code
812-8582
Address
1-3-3,Maidashi,Higashi-ku,Fukuoka-shi,Fukuoka
TEL
092-642-5954
toiwa@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Ishihara |
Organization
Kyushu University Hospital
Division name
Radiation department
Zip code
812-8582
Address
1-3-3,Maidashi,Higashi-ku,Fukuoka-shi,Fukuoka
TEL
092-642-5766
Homepage URL
oyuki@med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kyushu University Hospital
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
Kyushu University Center for Clinical and Translational Research
Address
1-3-3,Maidashi,Higashi-ku,Fukuoka-shi,Fukuoka
Tel
092-642-5774
tr-info@med.kyushu-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 | 10 | Month | 07 | 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
2
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 | 10 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 03 | 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
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 07 | Day |
Last modified on
| 2022 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043443
