Survey and comparing the effects of Benson relaxation and Progressive muscle relaxation on quality of sleep in patients after coronary artery bypass surgery
The objective of this clinical trial is to survey and compare the effects of benson relaxation and progressive muscle relaxation on quality of sleep in patients after coronary artery bypass surgery. The study population will be patients undergoing coronary artery bypass surgery in the shaid beheshtiy and valyasr hospital. One hundred twenty praticipants assigned to of Benson relaxation and progressive muscle relaxation or control groups. Methods: after surgery, when patients were transferred to the part, in the Second day, researcher will teach relaxation to patients by Mp3player. Then, a Mp3player and record sheet will be give to research unit. Patients will done the exercises twice a day fot 4 week at 20 minute using arelaxation Mp3player at home and after each time, the data will be record in the daily recorde sheet at the end of one and three week, researcher will discuss with phone calls about the research units relaxation exercise and problems. Before and four week after intervention, pisttburgh sleep quality index will be compelet. The control group will not receive any type of intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201703123064N6
Registration date:2017-04-19, 1396/01/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-04-19, 1396/01/30
Registrant information
Name
Hossein Bagheri
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
bagheri@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research (Research and
Technology), Shahroud University of Medical
Sciences
Expected recruitment start date
2017-05-05, 1396/02/15
Expected recruitment end date
2018-01-05, 1396/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey and comparing the effects of Benson relaxation and Progressive muscle relaxation on quality of sleep in patients after coronary artery bypass surgery
Public title
Survey and comparison the effect of relaxation on sleep quality of patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 40 to 75 years old; having written knowingly informed consent; No previous history of heart surgery; No history of mental illness diagnosed doctor; Bypass surgery Coronary artery bypass due to stenosis 2 vessels to 4 vessels; Poor sleep quality based on answers to a questionnaire Pittsburgh Sleep Quality (In Pittsburgh Sleep Quality Index (PSQI) earn score of 5-21); Do not use Sedations drugs other than routine. Exclusion criteria during study: Using any of the relaxation methods expect Benson and progressive during the study period; Not wanting to continue to contribute in study; do not receive sedative by routine in the part.
Age
From 40 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Ethics Committee of Shahroud University of Medical Sciences
Street address
Hafte-Tir square, Shahroud University of Medical Sciences
City
Shahroud
Postal code
3614773955
Approval date
2017-03-07, 1395/12/17
Ethics committee reference number
IR.SHMU.REC.1395.181
Health conditions studied
1
Description of health condition studied
Sleep disorder
ICD-10 code
G47.0
ICD-10 code description
Disorders of initiating and maintaining sleep [insomnias]
Primary outcomes
1
Description
Sleep quality
Timepoint
pre- intervention and 4 weeks after intervention
Method of measurement
Pittsburgh Sleep Quality Index
Secondary outcomes
empty
Intervention groups
1
Description
In the Benson relaxation group, one sessions of relaxation training will hold during 20-30 minutes by MP3 player through headphone. Then a MP3player and relaxation record sheet will give to the subjects and they will be ask to do relaxation practices twice a day in 20 minutes for 4 weeks. at the end of one and three week, researcher will call and speak about the practice and the their potential problems. 4 weeks after the start of study the Pittsburgh Sleep Quality Index will be completed.
Category
Behavior
2
Description
In the progressive muscle relaxation group, one sessions of relaxation training will hold during 20-30 minutes by MP3 player through headphone. Then a MP3player and relaxation record sheet will give to the subjects and they will be ask to do relaxation practices twice a day in 20 minutes for 4 weeks. at the end of one and three week, researcher will call and speak about the practice and the their potential problems. 4 weeks after the start of study the Pittsburgh Sleep Quality Index will be completed.
Category
Behavior
3
Description
In the control group, at the end of one and three week telephone contact is established in order to maintain contact. After 4 weeks, the Pittsburgh Sleep Quality Index will be completed again.