Effect of needs-based assessment of postoperative complications following knee replacement
Design
A total of 76 patients were enrolled in the study. To prevent the contact between patients in the intervention and control groups, the sampling was done as follows, patients in the intervention group were selected according to the list of operations for successive weeks until the number of samples was completed and then the control group sampling was continued up to completion of the number of samples.
Settings and conduct
The study is a semi-experimental clinical trial. The research environment in this study was orthopedic section of Qods Hospital in Arak.
Patients in both groups completed the questionnaires before surgery.After the completion of the intervention, postoperative complications were recorded during the period of hospitalization by assessing the patient's record and after discharge within one month after the operation.
Participants/Inclusion and exclusion criteria
Age over 18 years
The absence of immunosuppressive agents and diabetes
Lack of full participation in training sessions
Patients with 3≤ASA
Patients with BMI ≥3
Intervention groups
Patients in both groups completed the demographic and needs assessment questionnaires before surgery. Sample training was given in the intervention group after determining the educational priorities. While the control group received only routine training. One month after the operation, the questionnaire was completed again by patients
Main outcome variables
Complications in patients with knee replacement surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180913041022N1
Registration date:2018-11-10, 1397/08/19
Registration timing:retrospective
Last update:2018-11-10, 1397/08/19
Update count:0
Registration date
2018-11-10, 1397/08/19
Registrant information
Name
Saeedeh Shakeri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3366 3112
Email address
saide.sha.3@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-31, 1396/11/11
Expected recruitment end date
2018-06-01, 1397/03/11
Actual recruitment start date
2018-03-20, 1396/12/29
Actual recruitment end date
2018-06-04, 1397/03/14
Trial completion date
2018-07-02, 1397/04/11
Scientific title
Effect of needs-based education on postoperative complications of patients with knee arthroplasty
Public title
Effect of needs-based education on postoperative complications of patients with knee arthroplasty
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with knee joint disease (recorded in the file)
Have reading and writing skills
Age over 18 years
Not having previous experience in training programs
Not having previous joint replacement history
Replacement candidate for one knee
Lack of cognitive, visual acuity and hearing impairment
The absence of immunosuppressive diseases such as AIDS and hepatitis, heart disease (MI, CHF) and diabetes
Exclusion criteria:
Unwillingness to continue participating in the study
Exit the patient from the hospital with personal consent before discharging by a doctor
Lack of full participation in training sessions
Patients with ASA ≥3
Patients with BMI ≥3
Contact of each patient in the control group with each patient in the intervention group (in case of re-admission)
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
76
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
A researcher-made questionnaire was used in this study
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, Iran University of Medical Sciences, Valiasr St.,Shahid Rashid Yasemi St .
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶-۱۴۵۳۵
Approval date
2017-10-09, 1396/07/17
Ethics committee reference number
IR.IUMS.FMD.REC.1396.9311686015
Health conditions studied
1
Description of health condition studied
Complications after knee replacement
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Post knee joint surgery complications
Timepoint
Measurement of three common postoperative complications at the end of hospitalization time and one month after surgery during the first week of contact with the patient, the first referral of the patient to the office during the second week, the second week by contact with the patient, The second visit to the office during the fourth week, the third week and the fourth week by contact with the patient
Method of measurement
Assessing the patients' file, physician information, telephone to patients
2
Description
The patients' educational needs
Timepoint
Before surgery and one month after surgery
Method of measurement
A researcher-made questionnaire called the need-assessment questionnaire for knee replacement subjects
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the intervention group completed the demographic and needs assessment questionnaires before surgery. Sample training was done so that prior to the beginning of the training, a questionnaire on the needs assessment of the educational priorities was determined based on the educational needs of the patient, then each person was trained according to his needs. Individual and face-to-face training was provided for 3 days from day before surgery or the same day until the day of discharge per day for 15-20 minutes at patient's tolerance and capacity, and a manual was provided to patients in the intervention group . Patient education was also conducted by telephoning and meeting the patient's needs by answering his questions and ambiguities by availability of the researcher (telephone number was provided to the patients) at the time of discharge and telephone answering. And the researcher himself also contacted the patient every week and ensure patient follow up and answer the patient's questions.
Category
Other
2
Description
Control group: Patients in the preoperative control group completed the demographic information and needle assessment questionnaire. Patients in the control group received only regular training.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Quds Hospital
Full name of responsible person
Shakeri Saeedeh
Street address
Quds Hospital, Palestine Street
City
Arak
Province
Markazi
Postal code
3814179586
Phone
+98 86 3222 3019
Fax
+98 86 3222 2796
Email
hosghods@qums.ac.ir
Web page address
http://rozaneh81.mihanblog.com/page/1
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Kazem Malekoti
Street address
Shahid Hemmat Highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Fax
Email
adminsite@iums.ac.ir
Web page address
http://www.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
Saeedeh Shakeri
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Okhubat Alley 10, Bu-Ali Sina Street, Qods Town
City
Arak
Province
Markazi
Postal code
0
Phone
+98 86 3366 3112
Email
saide.sha.3@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Daryadokht Masror
Position
Academic staff
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing School, Yasemi Rashid Ave., Tehran Town
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 4365 1709
Fax
Email
daryadokht_masror@yahoo.com
Web page address
https://www.iums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Saeedeh Shakeri
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing School, Yasemi Rashid Ave., Tehran Town
City
Tehran
Province
Tehran
Postal code
861155865
Phone
+98 86 3366 3112
Fax
Email
saide.sha.3@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the questionnaire, statistical information, and outcomes are available
When the data will become available and for how long
Starting the access period from 1399
To whom data/document is available
For researchers working in academic and scientific institutions
Under which criteria data/document could be used
For researchers working in academic and scientific institutions, students and research centers
From where data/document is obtainable
Responsive email address of Saeedeh Shakeri
saide.sha.3@gmail.com
What processes are involved for a request to access data/document
Your application will be processed within one month after your request has been made