Effect of Sleep Intervention Programs on the Quality of Sleep of Patients in Cardiac Rehabilitation Center
Design
The study was a quasi-experimental research with control and test groups
Settings and conduct
Demographic and clinical profile and the Pittsburgh sleep quality questionnaire. Conducted in Afshar Heart Rehabilitation Center of Yazd
Participants/Inclusion and exclusion criteria
Inclusion criteria: cardiovascular diseases requiring cardiac rehabilitation, age of 18 years and older, familiarity with Persian language, and consent to participate in the study. Exclusion criteria: sleep disorder requiring medication before the rehabilitation, history of hypnotic drug use for more than 6 months, history of depression and anxiety according to psychiatrist, cognitive impairment (vision or hearing problem),
Intervention groups
Patients who participated in the rehabilitation program were considered as the experimental group, and patients who did not participate in the rehabilitation program or left the program despite being taught the need for rehabilitation, were assigned to the control group. . Based on a complete test and results of the initial exercise test of patients, having a companion, and other factors such as a history of heart surgery and myocardial infarction and patients' risk levels, the clinician specified the length and speed of exercise with treadmill and exercise program for any patient in the experimental group to perform the rehabilitation program. Accordingly, the intensity of training in the initial sessions started from 20% to 40% of the reserve heart rate and gradually increased to 60% in the last sessions. The cardiac rehabilitation program included 12 weeks of exercise, 3 sessions per week, and 3 sessions of training programs each for 45 minutes.
Yazd Shahid Sadoughi University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1824 1755
Email address
nasiriani@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-15, 1398/10/25
Expected recruitment end date
2020-04-13, 1399/01/25
Actual recruitment start date
2020-01-16, 1398/10/26
Actual recruitment end date
2020-04-21, 1399/02/02
Trial completion date
2020-04-21, 1399/02/02
Scientific title
Effect of Sleep Intervention Programs on the Quality of Sleep of Patients in Cardiac Rehabilitation Center
Public title
Effect of Sleep Intervention Programs on the Quality of Sleep
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
cardiovascular diseases requiring cardiac rehabilitation
consent to participate in the study
familiarity with Persian language
age of 18 years and older
Exclusion criteria:
sleep disorder requiring medication before the rehabilitation
history of hypnotic drug use for more than 6 months
cognitive impairment (vision or hearing problem)
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
35
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients who participated in the rehabilitation program were considered as the experimental group, and patients who did not participate in the rehabilitation program or left the program despite being taught the need for rehabilitation, were assigned to the control group. In both groups, the selection of samples continued until a sample size of 35 was achieved
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoghi University of Medical Sciences
Street address
Shahid Sadoughi University of Medical Sciences, Bahonar Square, Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2020-01-14, 1398/10/24
Ethics committee reference number
IR.SSU.REC.1398.200
Health conditions studied
1
Description of health condition studied
sleep disorder
ICD-10 code
G47.2
ICD-10 code description
Circadian rhythm sleep disorders
Primary outcomes
1
Description
The overall quality of sleep
Timepoint
Before and one week after the intervention
Method of measurement
The Pittsburgh Sleep Quality Index
2
Description
Sleep duration
Timepoint
Before intervention and one week after the intervention
Method of measurement
The Pittsburgh Sleep Quality Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Based on a complete examination and results of the initial exercise test of patients, having a companion, and other factors such as a history of heart surgery and myocardial infarction and patients' risk levels, the clinician specified the length and speed of exercise with treadmill and exercise program for any patient in the experimental group to perform the rehabilitation program. Accordingly, the intensity of training in the initial sessions started from 20% to 40% of the reserve heart rate and gradually increased to 60% in the last sessions. The cardiac rehabilitation program included 12 weeks of exercise, 3 sessions per week, and 3 sessions of training programs each for 45 minutes
Category
Treatment - Devices
2
Description
Control group: patients who did not participate in the rehabilitation program or left the program despite being taught the need for rehabilitation, were assigned to the control group
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Afshar Heart Rehabilitation Center of Yazd
Full name of responsible person
Fatemeh Ghaneh
Street address
Afshar Hospital،Jomhori Blvd
City
yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3525 5011
Email
nasiriani@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr.Masud.Mirezaee
Street address
Research Council of Yazd University of Medical Sciences
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
nasiriani@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
50
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
Yazd University of Medical Sciences
Full name of responsible person
Khadijeh Nasiriani
Position
ph.D of nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing, St Bou Ali, Boulevard Brigadier Fallahi,yazd,iran
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1755
Email
nasiriani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Khadijeh Nasiriani
Position
ph.D of nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing, St Bou Ali, Boulevard Brigadier Fallahi,yazd,iran
City
yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1755
Email
nasiriani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Khadijeh Nasiriani
Position
ph.D of nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing, St Bou Ali, Boulevard Brigadier Fallahi,yazd,iran
City
yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1755
Email
nasiriani@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
Not applicable
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