UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033871