Pain score evaluation after knee arthroplasty ,before and after relaxation in both group patients, pain score before and after relaxation in the treatment group, pain score before and after examination in the control group, pain score after knee arthroplasty in regard to age and gender in control and treatment groups and blood pressure and analgesic administration before and after intervention in both groups were determined and compared. This randomized clinical trials with control group performed on seniors who’s admitted to Shahid Beheshti and Millad hospitals in Kashan-Iran. Inclusion criteria for patients include: above 60 years old and use of spinal anesthesia for surgery. Exclusion criteria include: history of Benson relaxation technique, identified cognitive and mental problems, drug or alcohol abuse and severe visual and auditory disorders. The sample size is 34. 4h after surgery, visual instrument is used for evaluation of pain in both groups. In treatment group, relaxation will be performed on the first, second and third days after surgery (2 sessions in a day, each session 10-20 min with 6-8h interval between sessions). Pain evaluation in the treatment group is perform 30 min after intervention. Pain intensity, blood pressure and amount of prescribed analgesic drugs are evaluated in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017053134279N1
Registration date:2017-11-12, 1396/08/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-12, 1396/08/21
Registrant information
Name
Marzeih Modarresi Maraghei
Name of organization / entity
Faculty of Nursing and Midwifery, Yazd
Country
Iran (Islamic Republic of)
Phone
+98 31 5531 5779
Email address
modarresi.nurse@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Shahid Sadoughi Faculty of Nursing and Midwifery, Yazd-Iran.
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Benson's relaxation technique on postoperative pain after total knee replacement in elder patients
Public title
The effect of Benson's relaxation technique on postoperative pain after total knee replacement in elder hospitalized patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria for study: inclination to participate in research, at least 60 years old, patient’s candidate for knee arthroplasty surgery, use of spinal anesthesia for surgery. Exclusion criteria for study: history of the Benson relaxation technique, identified cognitive and mental problems, drug or alcohol abuse and severe visual and auditory disorders. Sample loss criteria: refusal to continue to participate in research by patients, surgery complication like bleeding and infection, use of pain pump for pain control after knee arthroplasty.
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
34
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
Ethics Committee of Shahid Sadoughi University of Yazd
Street address
Alley Bu Ali, Street General Fallahi, Safaieh, Yazd
City
Yazd
Postal code
Approval date
2017-07-18, 1396/04/27
Ethics committee reference number
IR.SSU.REC.1396.81
Health conditions studied
1
Description of health condition studied
Total knee replacement
ICD-10 code
M23.4
ICD-10 code description
Loose body in knee
Primary outcomes
1
Description
Postoperative pain after total knee replacement
Timepoint
Relaxation method will be preforming on treatment group patients in 1, 2 and 3 days after surgery. In each day tow 10-20 min sessions will be designed with 9-8h interval between sessions. Pain evaluation in treatment group will be performed 30 min after relaxation implantation.
Method of measurement
visual analog scale (VAS)
Secondary outcomes
1
Description
Blood pressure, narcotic drugs
Timepoint
blood pressure and amount of prescribed analgesic drugs are evaluated in both groups in 6 period after surgery.
Method of measurement
Barometer device, Patient records
Intervention groups
1
Description
Intervention group: Four hours after surgery, VAS method will be used for pain evaluation in control and treatment patients. Relaxation method will be preforming on treatment group patients in 1, 2 and 3 days after surgery. In each day tow 10-20 min sessions will be designed with 6-8h interval between sessions. Pain evaluation in treatment group will be performed 30 min after relaxation implantation. Pain intensity, blood pressure and amount of prescribed analgesic drugs are evaluated in both groups in 6 period after surgery.
Category
Behavior
2
Description
Control group: Four hours after surgery with spinal anesthesia, VAS method used for pain evaluation in patients and pain intensity, blood pressure and amount of prescribed analgesic drugs are evaluated in both groups in 6 period after surgery.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti And Milad Kashan
Full name of responsible person
Marzieh Modaresi
Street address
Spring bombed 11, 6 meters of spring, maghmal Harir alley, Amir Kabir Street, Kashan
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Yazd University of Medical Sciencesity of Medical Sciences
Full name of responsible person
Marzeih modarresi
Street address
Safaieh Street General Fallahi Alley Bu Ali
City
Geriatric Nursing Master
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,Yazd University of Medical Sciencesity 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
School of Nursing and Midwifey shahid Sadoughi Yazd
Full name of responsible person
Behnaz Enjezab
Position
Research Deputy of Shahid Sadoughi Faculty of Nursing and Midwifery, Yazd-Iran.
Other areas of specialty/work
Street address
Bouali Boulevard, General Street Fahlaieh Street, Safayeh
City
Yazd
Postal code
Phone
+98 983538241751
Fax
+98 35 3824 9705
Email
Modarresi.nurse@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery shahid Sadoughi Yazd
Full name of responsible person
Zohreh Kalani
Position
Master of Nursing
Other areas of specialty/work
Street address
Alley Bu Ali, Street General Fallahi,Safaieh
City
Yazd
Postal code
Phone
+98 35 3824 1751
Fax
+98 35 3824 9705
Email
Kalani_z@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery shaid Sadoughi
Full name of responsible person
Marzeih Modarresi
Position
Geriatric Nursing Master
Other areas of specialty/work
Street address
Spring bomber 11, 6 meter Spring, Kwi Harir maghmal, Street Amir Kabir