Pruritus is a common and disabling symptom experienced by end stage renal disease patients. Based on, present research is conducted to determine the effect of progressive muscle relaxation on pruritus of hemodialysis patients. This research is a randomized controlled clinical trial. Researcher refers to hemodialysis center of Modares hospital of Saveh and introduces the goal of research to patients, 60 patients with pruritus were selected with purposive sampling method and informed written consent was received. Data is collected by demographic data questionnaire, pruritus scale and visual analogue scale for determining of pruritus severity. Samples are randomizing allocated to intervention and control group and the questionnaires were completed by them. Researcher trains the progressive muscle relaxation method to intervention group. The training of PMR is done with one to one, face to face and practical method; also, instruction pamphlet and a compact disk of relaxation method are given to intervention group samples. After one month, pruritus severity of both group is assessed again and the before and after intervention results of intervention and control group are compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015091010076N6
Registration date:2016-08-13, 1395/05/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-13, 1395/05/23
Registrant information
Name
Maryam Saeedi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1417 3524
Email address
m.saeedi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Saveh medical sciences university
Expected recruitment start date
2015-06-20, 1394/03/30
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of progressive muscle relaxation on pruritus severity of hemodialysis patients
Public title
Effect of relaxation on pruritus
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: willing to participate in trial; hemodialysis history of 3 month; undergoing hemodialysis 3 times a week; history of pruritus for 2 week at least; having no dermal or non dermal disease producing pruritus(based on idea of physician); having wholly awareness and ability of hearing for learning of relaxation method; having no physical disability or psychological disease such as severe stress and depression; not using anti pruritus drugs.
Exclusion criteria: Not doing relaxation or don't complete the relaxation diary; use of anti pruritus drugs in research phase.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Saveh university of medical sciences
Street address
Saveh university of medical sciences, Taleghani St., Saveh
City
Saveh
Postal code
Approval date
2015-05-22, 1394/03/01
Ethics committee reference number
IRSAVEHUMS.REC1394.04
Health conditions studied
1
Description of health condition studied
End stage kidney disease
ICD-10 code
N18.5
ICD-10 code description
End stage kidney disease
Primary outcomes
1
Description
Pruritus
Timepoint
One month
Method of measurement
Pruritus scale and visual analogue scale for pruritus
Secondary outcomes
1
Description
Pruritus severity
Timepoint
One month
Method of measurement
Pruritus severity scale
Intervention groups
1
Description
Progressive muscle relaxation in intervention group for one month that was done daily by patient in 15 to 20 minutes.
Category
Behavior
2
Description
no intervention in control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hemodialysis center of Modares hospital of Saveh
Full name of responsible person
Maryam Saeedi
Street address
Modarres Hospital, Modarres Square, Saveh
City
Saveh
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Saveh university of medical sciences
Full name of responsible person
Dr. Mahmood Karimi
Street address
Saveh university of medical sciences, Taleghani St., Saveh
City
Saveh
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, Saveh 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
Saveh university of medical sciences
Full name of responsible person
Maryam Saeedi
Position
MS/ Faculty member
Other areas of specialty/work
Street address
Saveh university of medical sciences, Kaveh industrial city, Saveh
City
Saveh
Postal code
Phone
+98 86 4234 3395
Fax
Email
maryamsaeedi2009@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Saveh university of medical sciences
Full name of responsible person
Maryam Saeedi
Position
MS/ Faculty member
Other areas of specialty/work
Street address
Saveh university of medical sciences, Kaveh industrial city, Saveh
City
Saveh
Postal code
Phone
+98 86 4234 3395
Fax
Email
maryamsaeedi2009@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Saveh university of medical sciences
Full name of responsible person
Maryam Saeedi
Position
MS/ Faculty member
Other areas of specialty/work
Street address
Saveh university of medical sciences, Kaveh industrial city, Saveh
City
Saveh
Postal code
Phone
+98 86 4234 3395
Fax
Email
maryamsaeedi2009@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)