Randomized controlled trial of comparison of the self-efficacy and pain control in the patients undergoing total knee arthroplasty with and without empowerment program
Purpose of this single-blind randomized controlled trial is determination the effectiveness of the empowerment program on pain control and self-efficacy in patients undergoing knee arthroplasty referring to the Shohada, Shahid Mahallati and Alinasab hospitals in Tabriz, Iran. After convenience sampling, 98 patients will be randomly assigned to two groups using random allocation software. Inclusion criteria include the male and female patients aged 18 and over, who are being undergone total knee arthroplasty. In intervention group, an empowerment program based on linton cognitive behavior and Bandura behavior changing models will be used and it will be done for 6 weeks (one session before surgery and 5 sessions after surgery). The control group will receive no intervention. The study outcomes include self-efficacy and pain control which data related to them are gathered by a member of the research team through conducting interviews with the participants in both groups and using study tools, before and after completion of the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015101224484N1
Registration date:2016-03-15, 1394/12/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-03-15, 1394/12/25
Registrant information
Name
Akram Ghahramanian
Name of organization / entity
Tabriz university of medical sciences, Faculty of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 413477379
Email address
ghahramaniana@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Tabriz University of Medical Sciences, Tabriz, East Azarbayjan, Iran, Islamic Republic Of
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2016-07-01, 1395/04/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized controlled trial of comparison of the self-efficacy and pain control in the patients undergoing total knee arthroplasty with and without empowerment program
Public title
Self-efficacy and pain control in the patients undergoing total knee arthroplasty
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Male and female patients aged 18 and over, patients undergoing total knee arthroplasty, patients with no history of chronic diseases and no drug addiction. Exclusion criteria: patient’s death, complications during and after surgery
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The person who collects data of outcome variables, doesn't know which patient belongs to which group. Participants are selected using convenience sampling and randomly allocated to two groups of intervention and control by randomization allocation software.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Golgasht Ave., Daneshgah St., Tabriz, East Azarbayjan, Iran
City
Tabriz
Postal code
Approval date
2015-09-20, 1394/06/29
Ethics committee reference number
TBZMED.REC.1394.526
Health conditions studied
1
Description of health condition studied
Knee arthroplasty
ICD-10 code
Z96.651
ICD-10 code description
Presence of right artificial knee joint
Primary outcomes
1
Description
Self-efficacy
Timepoint
Before intervention and 6 weeks after intervention
Method of measurement
Pain Self-Efficacy Questionnaire
Secondary outcomes
1
Description
Pain control
Timepoint
Before intervention and 6 weeks after intervention
Method of measurement
Short-form McGill Pain Questionnaire
Intervention groups
1
Description
In the intervention group, an empowerment program based on Linton cognitive-behavior and Bandura behavior changing models will be used which is implemented for 6 weeks (one session before surgery and 5 sessions after surgery). In control group there will be no intervention.
Category
Behavior
2
Description
The control group receives no intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada hospital
Full name of responsible person
Nazila Mir-Maroofi
Street address
Shohada hospital, Golshahr St., Tabriz, East Azerbaijan, Iran
City
Tabriz
2
Recruitment center
Name of recruitment center
Shahid Mahallati hospital
Full name of responsible person
Nazila Mir-Maroofi
Street address
Kuchebagh St., Tabriz, East Azerbaijan, Iran
City
Tabriz
3
Recruitment center
Name of recruitment center
Alinasab hospital
Full name of responsible person
Nazila Mir-Maroofi
Street address
Eram St., Tabriz, East Azerbaijan, Iran
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Rashidi
Street address
Golgasht Ave., Daneshgah St., Tabriz, East Azarbayjan, Iran
City
Tabriz
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 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
Nazila Mir-Maroofi
Position
MSc student in Nursing\Nurse
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariaty St., Tabriz, East Azarbayjan, Iran
City
Tabriz
Postal code
Phone
+98 41 3347 7379
Fax
Email
nmirmaroofi@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
Akram Ghahramanian
Position
PhD of Nursing, Assistant professor
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariaty St., Tabriz, East Azarbayjan, Iran
City
Tabriz
Postal code
Phone
+98 41 3347 7379
Fax
Email
ghahramaniana@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Akram Ghahramanian
Position
PhD in Nursing- Assistant professor
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariaty St., Tabriz, East Azarbayjan, Iran
City
Tabriz
Postal code
Phone
Fax
Email
ghahramaniana@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)