The purpose of study is to evaluate the effect of mixed educational program on pain intensity and range of motion in patients undergoing hip and knee joint replacement. This study is a randomized controlled trial. Key inclusion and exclusion criteria: ability to understand Persian language; being over 18 years old ; lack of sensitivity to non steroidal anti-inflammatory drugs and analgesics; postoperative complications that affect the patients motor function. The study population is included all patients referred to hospital for hip and knee replacement surgery and the sample size is 64 people. The study intervention is consisted of a mixed education program on a group of 32 patients . 32 patients in control group will not receive any intervention. Intervention time is one month and after that study outcomes will be measure. pain intensity and range of motion and its differences will be evaluate.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014111619980N1
Registration date:2015-01-09, 1393/10/19
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-01-09, 1393/10/19
Registrant information
Name
Leila Amir Mohseni
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 4377 7966
Email address
amirmohseni.l@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-01-13, 1393/10/23
Expected recruitment end date
2015-02-09, 1393/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of mixed educational program on pain intensity and range of motion in patients undergoing hip and knee joint replacement
Public title
Effect of educational program on pain intensity and range of motion in patients undergoing joint replacement
Purpose
Supportive
Inclusion/Exclusion criteria
The inclusion criteria : ability to understand Persian language; 18 years and older; elective surgery; no history of mental illness and addiction to opioids; lack of sensitivity to non steroidal anti-inflammatory drugs and analgesics. The exclusion criteria : the patient do not want to continue cooperating on the project; postoperative complications that affect the patients motor function.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
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
Ahvaz Jundishapor University of Medical Sciences Ethics Committee
Street address
Ahvaz Jundishapur University of Medical Science, Golestan Autobahn, Ahvaz
City
Ahvaz
Postal code
Approval date
2014-11-15, 1393/08/24
Ethics committee reference number
ajums.rec.1393.259
Health conditions studied
1
Description of health condition studied
Knee and hip joint replacement
ICD-10 code
z96
ICD-10 code description
Presence of orthopaedic joint implants
Primary outcomes
1
Description
Pain intensity
Timepoint
second day, third day, fourth day, fifth day and one month after intervention
Method of measurement
Numerical scale vas
2
Description
Range of motion
Timepoint
Discharge time, two weeks and one month later
Method of measurement
Goniometer
Secondary outcomes
1
Description
Hip motor function
Timepoint
Before surgery, one month and three months after surgery.
Method of measurement
Womac score(hip) questionnaire
2
Description
knee motor function
Timepoint
Before surgery, one month and three months after surgery.
Method of measurement
Womac score(knee) questionnaire
3
Description
Quality of life
Timepoint
Preoperatively and 3 months postoperatively
Method of measurement
Short 12-question questionnaire quality of life
4
Description
Anxiety
Timepoint
Before the intervention, and preoperative
Method of measurement
Spielberger scale
Intervention groups
1
Description
Intervention group: The patient in addition to the usual treatments will receive the training sessions for 30 minutes which includes 20 minutes face to face training and 10 minutes questions and answers and then training booklet and CD will be provided to them.
Category
Rehabilitation
2
Description
Control group: just received their usual treatment
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Ahvaz City
Full name of responsible person
Leila Amirmohseni
Street address
Ahvaz Jundishapor University of Medical Sciences
City
Ahvaz
2
Recruitment center
Name of recruitment center
Ahvaz Oil Hospital
Full name of responsible person
Leila Amirmohseni
Street address
Ahvaz Jundishapor University of Medical Sciences
City
Ahvas
3
Recruitment center
Name of recruitment center
Razi Hospital of Ahvaz City
Full name of responsible person
Leila Amirmohseni
Street address
Ahvaz Jundishapor University of Medical Sciences
City
Ahvas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Ahvaz Jundishapor University of Medical Sciences
Full name of responsible person
Dr Seied Ahmad Hoseini
Street address
Ahvaz Jundishapur University of Medical Sciences, vice-chancellor for research and technology, Golestan street, Ahvaz, Khozestan
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Ahvaz Jundishapor University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz Jundishapor University of Medical Sciences
Full name of responsible person
Leila Amirmohseni
Position
MSc Student Of Nursing Education
Other areas of specialty/work
Street address
Nursing school
City
Ahvaz
Postal code
6143994353
Phone
+98 61 3377 7966
Fax
Email
amirmohseni.l@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapor University of Medical Sciences
Full name of responsible person
Abdolali Shariaty
Position
MSc Of Nursing Education
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, nursing school, Golestan road, Ahvaz, Khozestan
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 3377 7966
Fax
Email
amirmohseni.l@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapor University of Medical Sciences
Full name of responsible person
Leila Amirmohseni
Position
MSc Student Of Nursing Education
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, nursing school, Golestan road, Ahvaz, Khozestan
City
Ahvaz
Postal code
15794 - 61357
Phone
+98 61 3377 7966
Fax
Email
Amirmohseni.l@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)