Comparison of Effectiveness of self care education versus usual care on helplessness and pain in patients with osteoarthritis referring to Tabriz Rheumatological Clinics, 2012: A Randomized Controlled Trial Study
Purpose of this double blind randomized controlled trial study is evaluation the effectiveness of self care education on helplessness and pain in patients with osteoarthritis referring to Rheumatology Clinics of Tabriz University of Medical Sciences, Iran. Inclusion criteria of this study included : having knee idiopathic osteoarthritis; having primary education; Living in Tabriz and suburbs and exclusion criteria include: having age below 35 years; participated in similar studies; having history of surgery or Corticosteroid injection on knee joints.
After convenience sampling,150 participants will be randomly assigned to two group using Random.org Website. Self care ’s demands will determine with individualized interview for intervention group. Intervention stage will be held up at three sessions with one hour time. Educational materials will be distributed in booklet and CD of exercise training to intervention group. Program adherence will be follow with a phone calling twice a week to six weeks. The control group will receive usual treatment and the study materials will be provided for them at the end of study. Data were collected at baseline, six weeks, and 12 weeks.
Arthritis Helplessness Index with fifteen items and Visual Analog Scale for pain severity will be used to data collection. Helplessness and pain are primary outcomes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106086698N2
Registration date:2012-09-28, 1391/07/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-09-28, 1391/07/07
Registrant information
Name
Mozhgan Behshid
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
hsr_co@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
2012-10-21, 1391/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Effectiveness of self care education versus usual care on helplessness and pain in patients with osteoarthritis referring to Tabriz Rheumatological Clinics, 2012: A Randomized Controlled Trial Study
Public title
Effectiveness of Self Care Education on Helplessness
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria of this study included : having knee idiopathic osteoarthritis; having primary education; Living in Tabriz and suburbs and exclusion criteria include: having age below 35 years; participated in similar studies; having history of surgery or Corticosteroid injection on knee joints.
Age
From 35 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Golgasht st.
City
Tabriz
Postal code
Approval date
2012-08-06, 1391/05/16
Ethics committee reference number
4582/4/5
Health conditions studied
1
Description of health condition studied
osteoarthritis
ICD-10 code
M15-M19
ICD-10 code description
Arthrosis
Primary outcomes
1
Description
Helplessness
Timepoint
Before intervention, six weeks and 12weeks after intervention
Method of measurement
Arthritis Helplessness Index
2
Description
pain
Timepoint
before intervention, six weeks and 12 weeks after intervention
Method of measurement
Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: self care education programs which includes two sessions of disease meaning education
, non-pharmacological methods of pain control, nutrition and weight management, joint protection techniques, medication and a session for exercise training. period of these sessions is one hour.
Category
Lifestyle
2
Description
control group: According to the common protocol, routine treatment and training will be received without wane.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Sheikh _al_ reis clinic
Full name of responsible person
Ali reza Khabazi
Street address
City
Tabriz
2
Recruitment center
Name of recruitment center
Rheumatology Clinic of sina hospital
Full name of responsible person
Ali reza Khabazi
Street address
City
Tabriz
3
Recruitment center
Name of recruitment center
Gholghasht Clinic
Full name of responsible person
Susan Kolahi
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
National Public Health Management Center
Street address
Tavanir Exit, Pasdaran Highway
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Zhaleh Varmaziar
Position
Master of Nursing/ student
Other areas of specialty/work
Street address
Southern Shariati St.
City
Tabriz
Postal code
Phone
+98 41 1335 8718
Fax
Email
zhaleh.varmaziar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mojgan Behshid
Position
Master of Nursing/M.S
Other areas of specialty/work
Street address
Southern Shariati St.
City
Tabriz
Postal code
Phone
+98 41 1335 8718
Fax
Email
mojganbehshid@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mojgan Behshid
Position
Master of Nursing/M.S
Other areas of specialty/work
Street address
Southern Shariaty St.
City
Tabriz
Postal code
Phone
+98 41 1335 8718
Fax
Email
mojganbehshid@hotmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)