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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029733
Receipt No. 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 2019/03/17

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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
Email 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
Email kawada@med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University
Institute
Department

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
Email

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 Preinitiation
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
2019 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
2019 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033871

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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