Comparison of the effect of two different methods of using earplugs versus control group on the pain intensity and sleep quality in patients undergoing coronary artery bypass graft: a randomized clinical trial
To compare the effect of two different methods of using earplugs versus control group on the pain intensity and sleep quality in patients undergoing coronary artery bypass graft
Design
This is a randomized clinical trial, phase II, in which 84 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients undergoing coronary artery bypass graft who will refer to Chamran Hospital in Isfahan City during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 65 to 90 years
Indication of undergoing coronary artery bypass graft
Ability to reading
Exclusion criteria:
Deafness
Chronic sleep disorder
Using hypnotic drugs
Addiction to an opioid substance
Psychiatric disorders
Old hearing or using the hearing aid
Intervention groups
Intervention group 1:
Using earplug in twice from 2 to 5 pm during the midday sleep from 10 to 6 pm during the night sleep
Intervention group 2:
Using earplug in once from 10 to 6 pm during the night sleep
Control group:
Without using any earplug
Main outcome variables
Primary outcome:
Assessing the pain severity
Assessing sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N291
Registration date:2019-09-05, 1398/06/14
Registration timing:prospective
Last update:2019-09-05, 1398/06/14
Update count:0
Registration date
2019-09-05, 1398/06/14
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two different methods of using earplugs versus control group on the pain intensity and sleep quality in patients undergoing coronary artery bypass graft: a randomized clinical trial
Public title
Comparison of the effect of two different methods of using earplugs versus control group on the pain intensity and sleep quality in patients undergoing coronary artery bypass graft
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 65 to 90 years
Indication of undergoing coronary artery bypass graft
Ability of read
Exclusion criteria:
Deafness
Chronic sleep disorder
Using hypnotic drugs
Addiction to opioid substance
Psychiatric disorders
Old hearing or using hearing aid
Age
From 65 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare 84 sheets of paper, writing on 28 sheets the name of the intervention 1 and on 28 other sheets the name of the intervention 2 and on the third 28 sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all six sheets are drawn.
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 Isfahan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Isfahan University of Medical Sciences, Azadi Square, Hezarjarib Ave.
City
Hamadan
Province
Hamadan
Postal code
8174673465
Approval date
2019-08-18, 1398/05/27
Ethics committee reference number
IR. MUI.RESEARCH.REC.1398.293
Health conditions studied
1
Description of health condition studied
Coronary artery bypass graft
ICD-10 code
I25.729
ICD-10 code description
Atherosclerosis of autologous artery coronary artery bypass graft(s) with unspecified angina pectoris
Primary outcomes
1
Description
Assessing the pain severity
Timepoint
On the first, second, and third days after surgery
Method of measurement
Using a visual analog scale (VAS)
2
Description
Assessing sleep quality
Timepoint
On the first, second, and third days after surgery
Method of measurement
Using Veran Snaider Halpern (VHS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Using earplug in twice from 2 to 5 pm during the midday sleep from 10 to 6 pm during the night sleep
Category
Treatment - Devices
2
Description
Intervention group 2:Using earplug in once from 10 to 6 pm during the night sleep
Category
Treatment - Devices
3
Description
Control group:Without using any earplug
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran Hospital in Isfahan City
Full name of responsible person
Fatemeh Bastani
Street address
Chamran Hospital, Azadi Square, Hezarjarib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673465
Phone
+98 31 3792 7565
Email
f.bastani1971@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfarayen University of Medical Sciences
Full name of responsible person
Dr Shaghayegh Haghjooy Javanmard
Street address
Isfahan University of Medical Sciences, Azadi Square, Hezarjarib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673465
Phone
+98 31 3792 3060
Email
info.research@iums.ac.ir
Grant name
Grant code / Reference number
8174673465
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfarayen 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
Esfarayen University of Medical Sciences
Full name of responsible person
Fatemeh Bastani
Position
Nursing Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Isfahan
Province
Isfehan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
f.bastani1971@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Narges Kheirollahi
Position
PhD in Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
n.kheirollahi@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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