Determining the effect of cognitive-behavioral intervention on the quality of sleep in hemodialysis patients
Design
Participants were randomly selected from among the hemodialysis patients in the dialysis unit and randomly assinged in to the internention and control groups.
Settings and conduct
This randomized controlled trial was conducted
on patients undergoing maintenance hemodialysis
in hemodialysis centers of UrmiaThalegani Hospital. Eighty patients with sleep problem were
randomly selected..
Participants/Inclusion and exclusion criteria
Having undergone hemodialysis for at least 6 months،Who can read and write Persian،willing to participate
Intervention groups
Participants were randomly selected from among the hemodialysis patients in the dialysis unit and randomly assinged in to the internention and control groups. patients in the intervention group participated in 6 weekly sessions of half _ hour sleep hygiene training program. The content of training sessions was developed according to standard scientific methods.Direct teaching methods a combination of face_ to_face methods/lectures/ and group discussion were used. Training in each session was as follows:session1:Introduction/statement of research gools and explaining sleep physiology
Session2: Explaining effective factors on sleep and types of sleep disorders
Session3: overview of the sleep hygine education instructions
Session 4 and 5: Training behavioral intervention such as relaxtion and imagery practice
Session6: Review sessions/getting feed back from the sample/ and providing an educational pamphlet
The intervention group received cognitive behavioral therapy whereas the subjects in the control group received non-directive counseling while both the groups were receiving routine care.
The effect of Cognitive_Behavioral intervention on Sleep quality in hemodialysis patients
Public title
The effect ofCognitive_Behavioral intervention on Sleep quality inHemodialisis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having undergone hemodialysis for at least 6months
Scores above 5 in Pittsburgh sleep quality index
willing to participate
Who can read and write Persian
Exclusion criteria:
Suffering from known mental diseases including deep anxiety and depression(according to patient answer and his/her medical history)
Unwilling to participate
Waiting for transplant
Received any form of psychohterapy
Age
From 25 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Further the entire samples were randomly allocated into experimental and control groups by using computer generated random order
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 Urmia university of Medical sciences
Street address
headquarters of the university of medical science, Jahad ave, Resalat blvd.
City
Urmia
Province
West Azarbaijan
Postal code
57147-83734
Approval date
2017-06-06, 1396/03/16
Ethics committee reference number
Ir.umsu.rec.1396-100
Health conditions studied
1
Description of health condition studied
sleep disorders
ICD-10 code
F51
ICD-10 code description
Sleep disorders not due to a substance or known physiological condition
Primary outcomes
1
Description
The percentage of people whose quality Score in the sleep quality questionnaire above 5
Timepoint
measure of quality of sleep quality in starting of study and after 70 days cognitive behavioral intervention
Method of measurement
Data were collected by petersburg sleep quality questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In this study, 6 sessions of cognitive-behavioral intervention were performed. Interaction was done by agreement of patients, morning shift patients after hemodialysis and patients in the evening shift before hemodialysis sessions. At the beginning of each session, muscle relaxation and breathing exercises were performed for patients. The description of the intervention was based on scientific standards
Category
Behavior
2
Description
Control group: In this study, there was no intervention other than hemodialysis routine for the control group. After the end of the intervention, a manual of sleep hygiene education and pamphlet, a muscle relaxation technique was given to patients in the control group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Talegani hospital
Full name of responsible person
Rahim Bagaie
Street address
Kashani Ave,Talegani hospital
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3344 4591
Email
hajar65.razavi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Iraj mohebbi
Street address
Headquarters of the univercity of medical science, Jahad ave, Resalat blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3193 7224
Fax
+98 44 3224 0642
Email
mohebbi_iraj@yahoo.co.uk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Rahim Bagai
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and midwifery faculty,Nazloo road,Urmia Town
City
Urmia
Province
West Azarbaijan
Postal code
57147-83734
Phone
+98 44 3275 4918
Email
rbagaie@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Hajar Razavi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kashani Ave, Motahhari hospital
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3367 0503
Email
hajar65.razavi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
HajarRazavi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kashani Ave, Motahhari hospital, Urmia Town
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3367 0503
Email
hajar65.razavi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available