UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029733 |
|---|---|
| Receipt number | R000033871 |
| Scientific Title | Nursing intervention to decrease physical pain and psychological distress associated with wearing a shoulder abduction brace in a patient after rotator cuff repair surgery. |
| Date of disclosure of the study information | 2017/10/26 |
| Last modified on | 2020/11/03 21:05:17 |
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Basic information
Public title
Nursing intervention to decrease physical pain and psychological distress associated with wearing a shoulder abduction brace in a patient after rotator cuff repair surgery.
Acronym
Nursing intervention to decrease physical pain and psychological distress of brace users after rotator cuff repair surgery.
Scientific Title
Nursing intervention to decrease physical pain and psychological distress associated with wearing a shoulder abduction brace in a patient after rotator cuff repair surgery.
Scientific Title:Acronym
Nursing intervention to decrease physical pain and psychological distress of brace users after rotator cuff repair surgery.
Region
| Japan |
Condition
Condition
Rotator cuff tear
Classification by specialty
| Orthopedics | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to clarify the decrease of their physical pain and psychological distress associated with wearing a shoulder abduction brace by nursing intervention without any helping of a doctor from more early postoperative in a patient after rotator cuff repair surgery.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Result of questionnaires:
New Japanese version of State-Trait Anxiety Inventry(STAI)
Pain Catastrophizing Scale(PCS)
Questionnaires are performed at 3 times: before surgery, 7 days after surgery and suture removal time (usually 10 to 14 days after surgery).
Key secondary outcomes
Visual analog scale: VAS
Every days after surgery until 14 days after surgery.
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention group:
Two nurses practices to do attachment and detachment of the brace without any helping of a doctor from 7 days after surgery.
Interventions/Control_2
Control group:
Two nurses practices to do attachment and detachment of the brace without any helping of a doctor from 14 days after surgery.
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
Patients who met all criteria below.
1.Inpatients who had diagnosis rotator cuff tear and who had undergone rotator cuff repair surgery in Kyushu University Hospital.
2.Patients who have agreed in this study from their own will with document consents.
3. Patients who aged over 20 years and older at the time of informed consent.
Key exclusion criteria
Patients who falls into one of the three.
1.Patients who were diagnosed as a re-tear after rotator cuff repair surgery.
2.Patients were judged by researcher as unable to communicate with cognitive impairment or mental disorder.
3.Patients were judged by their doctor as delays attachment and detachment of their brace by doctor and nurse from 15 days after surgery.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoko Iwaya |
Organization
Kyushu University Hospital
Division name
Nursing Department
Zip code
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 | |
| Middle name | |
| Last name | Michiko Kawada |
Organization
Kyushu University Hospital
Division name
South 10th floor ward
Zip code
Address
1-3-3, Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka
TEL
092-642-5498
Homepage URL
kawada@med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Address
Tel
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
| 2017 | Year | 10 | Month | 26 | 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
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2020 | 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
| 2017 | Year | 10 | Month | 26 | Day |
Last modified on
| 2020 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033871
| 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 |
