This research is conducted to determine earplug effect on hospitalized patient`s sleep quality in CCU. This cross sectional studt will do by Inclusion criterias of age>18 years old, admitted during 12 md to 6pm on study day; expected length of stay in the ccu was at least 2 night; ability to read,write and understand Persian; lack of visual and auditory disorders and dementia; orientated;not using sedative drugs in past 24 hr or narcotics in 12 hr before intervention; no history of earplug use; sign a consent form and exclusion criteria of Any change in patient`s care plan, removal of earplug in less than 6 hr, rejecting the intervention. The study is designed by cross over clinical trial in which 92 sample in Heshmat therapeutic-educational center selected and were randomly allocated in two group A (46 with earplugs in first night and without it in second night ) and group B(46 without earplugs in first night and with it in second night). Data were gathered by 2-part tool including researcher-made demographic/clinical questionnaire and verran-snyder halpern sleep scale. Samples will ask to wear earplug during sleep hours by cross over design in two group A and B. The research assumption is that earplug can improve sleep quality in patients hospitalized in CCU.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201403031118N3
Registration date:2015-02-06, 1393/11/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-06, 1393/11/17
Registrant information
Name
Mojgan Baghaie Lakeh
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3332 1185
Email address
baghaie@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Social Determinants O Health Research Center, Guilan University Of Medical Science, Rasht, Iran
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The survey of earplug effect on patient`s sleep quality in CCUs
Public title
The survey of earplug effect on patient`s sleep quality in coronary care units (CCUs) of Heshmat Therapeutic-educational center- 2014
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criterias : age>18 years old; admitted during 12 md to 6pm at study day; expected length of stay in the ccu at least 2 night; ability to read,write and understand Persian language; lack of visual and auditory disorders and dementia; orientated to time and place; lack of taking sedative drugs in past 24 hourse or narcotics in 12 hours before intervention; no history of previouse use an earplug; sign a consent form to participate in the study
Exclusive criterias:Any change in patient`s care for example transfering out of CCU; intentional or accidental removal of earplug in any time less than 6 hours; rejecting the intervention by samples
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Commity Of Guilan University Of Medical Science
Street address
Vice T & RESEARCH ASSISSTANCE, West Shahid Beheshti Bolv.
City
Rasht
Postal code
4146939814
Approval date
2014-08-20, 1393/05/29
Ethics committee reference number
2930252806
Health conditions studied
1
Description of health condition studied
Heart Disease
ICD-10 code
120-125
ICD-10 code description
Ischemic Heart Disease
Primary outcomes
1
Description
Improving patients`sleep quality
Timepoint
1-2 hr after earplug removal in the morning
Method of measurement
Veran-snyder Halpern questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
earplugs in first night and without it in second night
Category
Prevention
2
Description
without earplugs in first night and with it in second night
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Therapeutic-educational center of DR.Heshmat
Full name of responsible person
Mojgan Baghaie Lakeh
Street address
Imamkhomeini Street, Therapeutic-educational center of DR.Heshmat
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Social Determinants Of Health Research Center, Guilan University Of Medical Science, Rasht, Iran>
Full name of responsible person
Mojgan Baghaie Lakeh
Street address
Social Determinants Of Health Research Center, Shahid Beheshti Nursing & Midwifery college, Daneshju Street, Shahid beheshti Bolv.
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Social Determinants Of Health Research Center, Guilan University Of Medical Science, Rasht, Iran>
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
Name of organization / entity
Social Determinants Of Health Research Center, Guilan University of Medical Science, Rasht, Iran
Full name of responsible person
Mojgan Baghaie Lakeh
Position
Faculty member
Other areas of specialty/work
Street address
Social Determinants Of Health Research Center, Shahid Beheshti Nursing & Midwifery College, Daneshju Street. Shahid Beheshti Bolv.
City
Rasht
Postal code
4146939814
Phone
+98 13 3355 5056
Fax
+98 13 3355 0097
Email
baghaie@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Social Determinants Of Health Research Center, Guilan University Of Medical Science, Rasht, Iran
Full name of responsible person
Mojgan Baghaie Lakeh
Position
Faculty Member
Other areas of specialty/work
Street address
Social Determinants Of Health Research Center, Shahid Beheshti Nursing & Midwifery College, Daneshju Street, Shahid Beheshti Bolv.
City
Rasht
Postal code
4146939814
Phone
+98 13 3355 5056
Fax
+98 13 3355 0097
Email
baghaie @gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Social Determinants Of Health Research Center, Guilan University Of Medical Science, Rasht, Iran
Full name of responsible person
Mojgan Baghaie Lakeh
Position
Faculty Member
Other areas of specialty/work
Street address
Social Determinants Of Health Research Center, Shahid Beheshti Nursing & Midwifery college, Daneshju Street, Shahid Beheshti Bolv.
City
Rasht
Postal code
4146939814
Phone
+98 13 3355 5056
Fax
+98 13 3355 0097
Email
baghaie@gums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)