The presents study aims to investigate the effects of progressive muscle relaxation techniques on sleep quality and sleepiness of hemodialysis patients. It is a clinical study and is not blinded. 74 hemodialysis patients in Imam Reza hospital were selected randomly and divided to control and experiment groups. To assess sleep quality and pattern, PSQI questionnaire was delivered to both groups. Then, the experiment group was asked to do relaxation practices twice a day for 6 weeks at home based on a schedule. One try must be accomplished before night sleep. Finally, patients who followed over %70 of their schedule went under final investigation and the rest were omitted from the study. There was no special treatment passed to control group. After 6 weeks, PSQI questionnaire was offered to the patients in both groups to study their total quality of sleeping, delayed sleep, practical sleep duration, enough sleep, sleeping disorders, taking sleeping pills and daily dysfunction.
Inclusion: being hemodialysis for at least two months; willingness to participate in the study; patients in experiment group included patients at evening and night shifts; patients in control group were the morning shift.
Exclusion: being younger than 15
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015052114333N33
Registration date:2015-06-11, 1394/03/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-11, 1394/03/21
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
kermanshah University of Medical Sciences
Expected recruitment start date
2015-05-15, 1394/02/25
Expected recruitment end date
2015-07-06, 1394/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effectiveness and ineffectiveness of progressive muscle relaxation techniques on sleep quality and sleepiness of hemodialysis patients
Public title
Effectiveness of progressive muscle relaxation techniques on sleep quality and sleepiness of hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: being hemodialysis for at least two months; willingness to participate in the study; patients in experiment group included patients at evening and night shifts; patients in control group were the morning shift.
Exclusion: being younger than 15
Age
From 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
74
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
Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2015-04-28, 1394/02/08
Ethics committee reference number
kums.rec.1394.6
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
N18
ICD-10 code description
Chronic renal failure
Primary outcomes
1
Description
Delay sleep
Timepoint
At the beginning of the study and 6 weeks later
Method of measurement
PSQI questionnaire
2
Description
Practical sleep duration
Timepoint
At the beginning of the study and 6 weeks later
Method of measurement
PSQI questionnaire
3
Description
Enough sleeping
Timepoint
At the beginning of the study and 6 weeks later
Method of measurement
PSQI questionnaire
4
Description
Sleeping disorders
Timepoint
At the beginning of the study and 6 weeks later
Method of measurement
PSQI questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
To assess sleep quality and pattern in experiment group, PSQI questionnaire was delivered to them. They were asked to do relaxation practices twice a day for 6 weeks at home based on a schedule. One try must be accomplished before their night sleep. Finally, patients who followed over %70 of their schedule went under final investigation and the rest were omitted from the study. After 6 weeks, PSQI questionnaire was offered to the patients in experiment group to study their total quality of sleeping, delayed sleep, practical sleep duration, enough sleep, sleeping disorders, taking sleeping pills and daily dysfunction.
Category
Behavior
2
Description
There was no special treatment delivered to control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam reza Hospital
Full name of responsible person
Fatemeh Hadadian
Street address
Emamreza hospital, Parastar boulevard
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
ّFereshteh Jalalvandi
Position
Msc. of Surgical Internal Nursing
Other areas of specialty/work
Street address
School of Paramedical Sciences, First of Dolatabad Boulvard,Eisar Square
City
Kermanshah
Postal code
Phone
+98 83 3828 0642
Fax
Email
fjalalvandi@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)