The purpose of this study was to determine the effect of progressive muscle relaxation on sleep quality of patients undergoing hemodialysis in hospitals affiliated with Shahid Beheshti University of Medical Sciences in year 2010. This is a one-group before and after semi-experimental study. Based on Sample size formula, 30 patients were selected by objective oriented method and written consent of the samples was obtained for the study. Sleep quality of samples were assessed by Pittsburgh Sleep Quality Index and two weeks sleep diary, then progressive muscle relaxation was taught during the third session, after a month sleep quality of samples were assessed again and sleep quality of patients were compared before and after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902152846N5
Registration date:2010-10-02, 1389/07/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-10-02, 1389/07/10
Registrant information
Name
Tahereh Ashktorab
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 1543
Email address
t_ashktorab@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
private
Expected recruitment start date
2010-04-03, 1389/01/14
Expected recruitment end date
2010-06-20, 1389/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of progressive muscle relaxation on sleep quality in patients undergoing hemodialysis
Public title
Effect of relaxation on sleep quality in patients undergoing hemodialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 18 years old and over; experience of at least 6 months of hemodialysis; Hemodialysis 2 to 3 times a week; No history of mental disabilities; literacy as ability to read and write. Having full consciousness, acceptable ability of listening and speaking to answer questions and learn relaxation technique; Having the possibility of using CD-ROM Training. Exclusion criteria: If the patients didn’t want to continue participating in the study; If occur a crisis or an unforeseen event for patients during the intervention period; If the patient didn’t complete two weeks sleep diary; If the patient didn’t complete relaxation diary.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences and Health Services
Street address
Velenjak
City
Tehran
Postal code
Approval date
2010-06-13, 1389/03/23
Ethics committee reference number
88018668151
Health conditions studied
1
Description of health condition studied
sleep disorders in hemodialysis patients
ICD-10 code
N18.9
ICD-10 code description
Chronic renal failure, unspecified
Primary outcomes
1
Description
sleep quality
Timepoint
1 month
Method of measurement
Pittsburgh Sleep Quality Index and two week sleep diary
Secondary outcomes
1
Description
insomnia
Timepoint
1 month
Method of measurement
insomnia severity index and two week sleep diary
Intervention groups
1
Description
progressive relaxation muscle training, two times a day for 1 month
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Hemodialysis center of hospitals affiliated with shahid Beheshti University of Medical Sciences
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
private
Full name of responsible person
Maryam Saeedi
Street address
Shariati st, end of Mirdamad ave, next to Mofid hospital, Nursing and midwifery school of Shahid Beheshti
City
Tehran
Grant name
-
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
private
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
Nursing and Midwifery school of Shahid Beheshti university
Full name of responsible person
Tahereh Ashktorab
Position
Nursing PHD, Assistant Professor
Other areas of specialty/work
Street address
Shariati st, end of Mirdamad ave, next to Mofid hospital, Nursing and midwifery school of Shahid Beheshti