Introduction: Sleep disorders are common in hemodialysis patients. High prevalence of sleep disorders should be addressed. Present study has conducted to determine the effect of sleep hygiene training program on sleep quality of hemodialysis patients.
Methods: This study is a clinical trial study. 82 hemodialysis patients of Arak Valiasr hospital are randomly selected and randomly allocated in intervention(n=41) and control(n=41) groups. Sleep quality is assessed by Pittsburgh Sleep Quality Index. Sleep hygiene program is trained to Intervention group and after a month sleep quality will be assessed in two groups again and are compared with before.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012062010076N1
Registration date:2012-08-09, 1391/05/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-09, 1391/05/19
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
Arak University of Medical Sciences
Expected recruitment start date
2011-09-21, 1390/06/30
Expected recruitment end date
2011-10-22, 1390/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sleep hygine teaching program on sleep qualit of hemodialysis patients
Public title
Effect of sleep hygiene on sleep quality
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: intent for participating in the study, having18 years old to 65; experience of at least 6 months of hemodialysis; Having full consciousness, acceptable ability to learn sleep hygine programme; No history of mental disabilities such as severe depression and anxiety; literacy as ability to read and write.
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;
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:
82
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
arak medical sciances university
Street address
arak, sardasht, basij square
City
arak
Postal code
Approval date
2011-09-05, 1390/06/14
Ethics committee reference number
90-112-7
Health conditions studied
1
Description of health condition studied
Chronic renal disease
ICD-10 code
N18.9
ICD-10 code description
Chronic renal disease, unspecified
Primary outcomes
1
Description
sleep quality
Timepoint
before intervention and one month after intervention
Method of measurement
Pittsburg sleep quality index
Secondary outcomes
empty
Intervention groups
1
Description
The intervantion is sleep hygiene teaching programme that only were teached to intervention group during 5 session and includes introduction of study, sleep physiology and effective factors on sleep and also the instructions such as avoid disturbance agents of Sleep, appropriate sleep environment and teaching behavioral intervention such as relaxationand imagery guiding to promote sleep quality of patients.
Category
Behavior
2
Description
in control group, no intervention is done and control group recieve routin care.