UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050536 |
|---|---|
| Receipt number | R000057411 |
| Scientific Title | Impact of Occupational Therapy Practice Using Coping Skills on Pain and Psychological Factors in Patients After Knee Replacement Surgery |
| Date of disclosure of the study information | 2023/03/09 |
| Last modified on | 2025/04/23 16:12:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Impact of Occupational Therapy Practice Using Coping Skills on Pain and Psychological Factors in Patients After Knee Replacement Surgery
Acronym
A Study of Occupational Therapy Interventions Using Coping Skills
Scientific Title
Impact of Occupational Therapy Practice Using Coping Skills on Pain and Psychological Factors in Patients After Knee Replacement Surgery
Scientific Title:Acronym
A study of occupational therapy intervention in patients after knee replacement surgery
Region
| Japan |
Condition
Condition
Post knee joint replacement
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effectiveness of occupational therapy using coping skills for post-operative knee replacement patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurements will measure pain and psychological factors postoperatively and at discharge.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Only in the intervention group, occupational therapy using coping skills is practiced to promote goal achievement.
Interventions/Control_2
The control group will receive usual occupational therapy interventions.
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
| 60 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent knee joint replacement surgery at the first author's institution.
Key exclusion criteria
Exclusion criteria are 1) those who do not consent to occupational therapy, 2) those who present with systemic arthritic symptoms such as rheumatoid arthritis, 3) those who have psychiatric disorders such as schizophrenia, 4) stroke and Parkinson's disease, etc. Those who have neurosurgical disease of 5) who do not understand oral instructions.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ryusei |
| Middle name | |
| Last name | Hara |
Organization
Sunwells Co., Ltd.
Division name
Service Development Department
Zip code
812-0011
Address
5F, Hakata Tanaka Building, 3-27-24 Hakataekimae, Hakata-ku, Fukuoka-shi, Fukuoka 812-0011, Japan
TEL
092-260-8839
ryusei132@gmail.com
Public contact
Name of contact person
| 1st name | ryusei |
| Middle name | |
| Last name | hara |
Organization
Sunwells Co., Ltd.
Division name
Service Development Department
Zip code
812-0011
Address
5F, Hakata Tanaka Building, 3-27-24 Hakataekimae, Hakata-ku, Fukuoka-shi, Fukuoka 812-0011, Japan
TEL
092-260-8839
Homepage URL
ryusei132@gmail.com
Sponsor or person
Institute
Fukuoka Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
not
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
Fukuoka Rehabilitation Hospital
Address
7-770 Nogata, Nishi-ku, Fukuoka City, Fukuoka Prefecture
Tel
092-812-1555
ryusei
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
| 2023 | Year | 03 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
doi: 10.3390/healthcare13060627.
Number of participants that the trial has enrolled
36
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
| 2020 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 08 | Day |
Last modified on
| 2025 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057411
