This controlled clinical trial study will conduct to determine the effectiveness of ear plug and eye mask on nocturnal sleep quality in patients of Cardiac Intensive Care Unit. Firstly, the level of noise and light will be monitored for 24 hours in two random days in CCU. 68 patients will select via convenience sampling, then the subjects will allocate into four groups (three intervention groups and a control group) by using stratified random allocation. Intervention will be take place on patients with IHD at second night of hospitalization in CCU. On second night, all subjects (intervention and control groups) will complete Verran and Snyder-Halpern Sleep Scale (VSH Sleep Scale) and the level of melatonin and cortisol will be measured. Eye mask, ear plug and both eye mask and ear plug will be used respectively for three intervention groups on third night. After intervention, the level of melatonin and cortisol will be measured for all subjects, and sleep scale will be completed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014061717237N2
Registration date:2014-10-15, 1393/07/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-15, 1393/07/23
Registrant information
Name
Mahnaz Modanloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3245 6900
Email address
modanloo.mahnaz@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research & Technology, Golestan University of Medical Sciences
Expected recruitment start date
2014-03-18, 1392/12/27
Expected recruitment end date
2015-03-18, 1393/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Ear Plug and Eye Mask on Nocturnal Sleep Quality in Patients of Cardiac Intensive Care Unit
Public title
The Effects of Ear Plug and Eye Mask on Patients' Nocturnal Sleep Quality
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age between 18 and 65 years old, consciousness, orientation to time and place, have no sleep disorders, have no visual and hearing problem, the absence of psychiatric disorders, have no history of night-shift work at least in past 3 years, no use of coffee, alcohol and hypnotic medication at least 12 hours before the study time.
Exclusion criteria: Occurrence of sleep disorders during study period (such as sleep apnea, narcolepsy, restless leg syndrome), use of hypnotic medication during study period, the onset of menstruation in female patients during the study, patients who will be discharged or died during the study, sleeping confounding medications (e.g., opiates, amphetamines), receive tranquilizers and anesthetics, cardiopulmonary resuscitation during the study.
Age
From 17 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization strategies: Considering age, gender and cause of hospitalization, patients were allocated to three matched intervention groups (eye mask, ear plug and both eye mask and ear plug) and control group. Allocation will be achieved using stratified random allocation.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee
Street address
Deputy of Research and Technology, Golestan University of Medical Sciences (Falsafi Complex), Hirkan Boulevard, Gorgan
City
Gorgan
Postal code
4934174515
Approval date
2014-03-18, 1392/12/27
Ethics committee reference number
394592122510
Health conditions studied
1
Description of health condition studied
Ischaemic Heart Diseases
ICD-10 code
I24
ICD-10 code description
Other acute ischemic heart diseases
Primary outcomes
1
Description
Sleep
Timepoint
Before and a day after intervention
Method of measurement
Verran and Snyder Halpern Sleep Scale
Secondary outcomes
1
Description
Melatonin
Timepoint
Before and a day after intervention
Method of measurement
The measurement of urinary melatonin
2
Description
Cortisol
Timepoint
Before and a day after intervention
Method of measurement
The measurement of urinary cortisol
Intervention groups
1
Description
Eye Mask Group:
For this group of patients, in addition to routine care, eye mask (made of black cloth) will be used from 22 pm on the third day of hospitalization to 7 am of next day.
Category
Prevention
2
Description
Ear Plugs Group:
For this group of patients, in addition to routine care, the ear plug (Elvex Mark، Quattro model, four-step ،lace) will be used from 22 pm on the third day of hospitalization to 7 am of next day.
Category
Prevention
3
Description
Ear Plugs and Eye Mask Group:
For this group of patients, in addition to routine care, eye mask and ear plug will be used from 22 pm on the third day of hospitalization to 7 am of next day simultaneously.
Category
Prevention
4
Description
Control group, without any intervention.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Medical & Educational Center
Full name of responsible person
Gholam Ali Riahi
Street address
Amiralmomenin Medical Center, Mirza Kochak Khan street, Kordkuy
City
Kordkuy
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Technology
Full name of responsible person
Masood KhoshNia
Street address
Deputy of Research and Technology, Golestan University of Medical Sciences (Falsafi Complex), Hirkan Boulevard, Gorgan
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology
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
Golestan University of Medical Sciences
Full name of responsible person
Somayeh Rezvani Khorshidi
Position
MS Student of Critical Nursing Care
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Golestan University of Medical Sciences (Falsafi Complex), Hirkan Boulevard, Gorgan
City
Gorgan 09115735519
Postal code
4917136536
Phone
+98 17 3242 6900
Fax
+98 17 3242 5171
Email
rezvani_khorshidi@yahoo.com
Web page address
www.goums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Mahnaz Modanloo
Position
PhD
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Golestan University of Medical Sciences (Falsafi Complex), Hirkan Boulevard, Gorgan
City
Gorgan
Postal code
4917136536
Phone
+98 17 3242 6900
Fax
+98 17 3242 5171
Email
modanloo.mahnaz@goums.ac.ir; modanloo1@yahoo.com
Web page address
http://goums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Somayeh Rezvani Khorshidi
Position
MS Student of Critical Nursing Care
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Golestan University of Medical Sciences (Falsafi Complex), Hirkan Boulevard, Gorgan
City
Gorgan
Postal code
4917136536
Phone
+98 17 3242 6900
Fax
+98 17 3242 5171
Email
rezvani_khorshidi@yahoo.com
Web page address
www.goums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)