Determining the effect of rehabilitation education on surgical outcomes in patients undergoing knee replacement
Design
non-randomized clinical trial with control group. Continuous non-probabilistic approach. Sample size: 48 subjects in each group
Settings and conduct
The environment of this research is the orthopedic sections of the Milad Hospital (orthopedics of men and women). Firstly, all eligible patients were placed in the control group and after completing the sampling in this group, the intervention group entered the study.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
aged 50-70 years old
Suffering from knee osteoarthritis
undergoing total knee replacement
No affection to acute anxiety disorder, depression and psychological problems and not taking psychoactive drugs before and after surgery.
Having no history of joint replacement or surgery on the knee
Having a BMI of less than 30 kg / m2
Having reading and writing skills
Non-arrival conditions:
Pre-surgery infection that affects the outcome of the research
Failure to co-operate with the patient in exercising and training
Patients unable to walk and unable to attend exercises
There are some underlying problems in the patient that make it impossible to attend rehabilitation sessions such as: severe heart and respiratory disease
Intervention groups
In the intervention group: intervention training (one day before surgery) and (24 and 48 hours after operation until discharge) and then (6 weeks after intervention), anxiety and womac questionnaire were completed before and 6 weeks after the intervention
In the control group: routine training was done and the anxiety and womac questionnaires were completed before and 6 weeks after the study.
Main outcome variables
Anxiety, Knee pain and Stiffness, and Physical Function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091124002769N6
Registration date:2018-06-18, 1397/03/28
Registration timing:retrospective
Last update:2018-06-18, 1397/03/28
Update count:0
Registration date
2018-06-18, 1397/03/28
Registrant information
Name
Mansoureh Ashghaly Farahani
Name of organization / entity
Iran University Medical Sciences ,Nursing & Miwifery Faculty
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1615
Email address
farahani.ma@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2017-09-22, 1396/06/31
Expected recruitment end date
2017-11-20, 1396/08/29
Actual recruitment start date
2017-09-22, 1396/06/31
Actual recruitment end date
2017-12-10, 1396/09/19
Trial completion date
empty
Scientific title
The effect of Rehabilitation Education on surgical outcomes in patients Who undergo a Total knee Replacement
Public title
The effect of Rehabilitation Education in patients Who undergo a Total knee Replacement
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
50-70 years old
Men and women with osteoarthritis
undergoing total knee replacement
No affection to acute anxiety disorder, depression and psychological problems and not taking psychoactive drugs before and after surgery. (According to the patient's statements and the diagnosis of physical and mental health by referring to the patient's medical records)
Having no history of joint replacement or surgery on the knee
Having a BMI of less than 30 kg / m
Having reading and writing skills (and in case of no literacy, one of the literate carers should be involved in the patient's education process)
Exclusion criteria:
Pre-surgery infection that affects the outcome of the research
Failure to co-operate with the patient in exercising and training
Patients unable to walk and unable to attend exercises
There are some underlying problems in the patient that make it impossible to attend rehabilitation sessions such as: severe heart and respiratory disease
Age
From 50 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Actual sample size reached:
96
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2017-06-23, 1396/04/02
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9311689001
Health conditions studied
1
Description of health condition studied
knee replacement in osteoarthritis patient
ICD-10 code
M15.0
ICD-10 code description
Primary generalized (osteo)arthrosis
Primary outcomes
1
Description
Anxiety
Timepoint
before & 6 weeks afterintervention
Method of measurement
Spielberg state anxiety questionnaire
2
Description
pain, stiffness and physical function
Timepoint
before & 6 weeks afterintervention
Method of measurement
WOMAC questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 4 educational sessions including: the day before Intervention , 24 hours after surgery (after leaving the bed), 48 hours after surgery, and then during discharge, using lecture, group and individual training,question and answer, and Role play and Complete the questionnaires before intervention and 6 weeks after intervention.
Category
Rehabilitation
2
Description
Control group: receiving routine training Intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Milad Hospital
Full name of responsible person
Mansoureh Ashgholi Farahani
Street address
Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614531
Phone
+98 21 82039
Fax
+98 21 8806 2005
Email
info@miladhospital.com
Web page address
http://miladhospital.com/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sayed Kazem Malekoti Deputy Director of Research in Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Web page address
http://iums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Batoul Atabaki
Position
MS student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Iran University of Medical Sciences- Hemmat highway next to Milad tower- Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Fax
Email
shryda.atabaki@yahoo.com
Web page address
http://iums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mansoureh Ashghali Farahani
Position
Phd of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Iran University of Medical Science- Hemmat highway next to Milad tower- Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Fax
Email
Farahani.ma@iums.ac.ir
Web page address
http://iums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Batoul Atabaki
Position
MS student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Iran University of Medical Science- Hemmat highway next to Milad tower- Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Fax
Email
sheyda.atabaki@yahoo.com
Web page address
http://iums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Participants data file (without name and profile and confidential)
Consent Form Conscious
When the data will become available and for how long