The effect of using and without using eye mask and earplugs on sleep quality, incidence of delirium, Physiological parameters and length of stay for patients admitted to the CCU
Present study aims to investigate the effects of using blinders and earplugs on sleep quality, range of Delirium incidence and physiologic parameters among patients admitted CCU. It is a clinical experimental study. 80 patients with cardiac problems were selected as samples randomly and divided into 3 treatment groups and one control group. Intervention started by having the first group using blinders, the second one earplug, and the third both blinders and earplugs from the second night attending hospital. Using standard questionnaires (CCU, dizziness evaluation), Petsburg sleep quality, Delirium outbreak and, also, physiological parameters were evaluated while the patients were staying at the hospital. No instruction was included among control group.Inclusion study: recognizing time; place and people; having no operation; having no visual or auditory problems; not using psychic medicine; having no mental disorders; having no known sleeping disorders; no addiction to drugs; not having disorders affecting sleeping such as migraine; staying CCU for at least 3 days; least GCS equal to 12; not having the patient intubed. Exclusion indexes: having serious problems being in CCU; quitting the study on patients will; cardiac-pulmonary revival throughout the study; receiving drugs which affect night sleep such as duretics ; prescribing sedative drugs.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013122914333N14
Registration date:2014-01-17, 1392/10/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-01-17, 1392/10/27
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2014-07-22, 1393/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of using and without using eye mask and earplugs on sleep quality, incidence of delirium, Physiological parameters and length of stay for patients admitted to the CCU
Public title
The effect of using eye mask and earplugs on sleep quality, incidence of delirium, Physiological parameters and length of stay for patients admitted to the CCU of Imam Ali Hospital in Kermanshah in 2013
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion study: recognizing time; place and people; having no operation; having no visual or auditory problems; not using psychic medicine; having no mental disorders; having no known sleeping disorders; no addiction to drugs; not having disorders affecting sleeping such as migraine; staying CCU for at least 3 days; least GCS equal to 12; not having the patient intubed. Exclusion indexes: having serious problems being in CCU; quitting the study on patients will; cardiac-pulmonary revival throughout the study; receiving drugs which affect night sleep such as duretics ; prescribing sedative drugs.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not 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
Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2013-12-21, 1392/09/30
Ethics committee reference number
40779پ/7/420
Health conditions studied
1
Description of health condition studied
Nonorganic sleep disorders
ICD-10 code
F51
ICD-10 code description
Nonorganic sleep disorders
Primary outcomes
1
Description
Sleep quality
Timepoint
Beginning and end of attending hospital
Method of measurement
According to Pitsburg questionnaire
2
Description
Delirium range
Timepoint
Daily, since the second day of attending till leaving hospital
Method of measurement
According to dizziness evaluation questionnaire NEE CHAM
3
Description
During attending hospital
Timepoint
Leaving hospital
Method of measurement
According to patient profile
4
Description
Blood pressure
Timepoint
Daily during attending hospital
Method of measurement
Using an automatic pressure check equipment while seating from left arm
5
Description
Temperature
Timepoint
Daily during attending hospital
Method of measurement
Using a mercury thermometer in mouth
6
Description
Heart beats
Timepoint
Daily during attending hospital
Method of measurement
Using monitoring tools
7
Description
Breath counts
Timepoint
Daily during attending hospital
Method of measurement
Chest movement counts by an expert in one minute
8
Description
SPO2
Timepoint
Daily during attending hospital
Method of measurement
Using pals eximeter
9
Description
Consciousness level
Timepoint
Daily during attending hospital
Method of measurement
Considering three visual, verbal and motor response parameters
Secondary outcomes
empty
Intervention groups
1
Description
Intervention in the first treatment group included using blinders from 10 pm to 7 am since the second night of attending CCU.
Category
Treatment - Other
2
Description
Intervention in the second treatment group included using earplugs from 10 pm to 7 am since the second night of attending CCU.
Category
Treatment - Other
3
Description
Intervention in the third treatment group included using both blinders and earplugs from 10 pm to 7 am since the second night of attending CCU.
Category
Treatment - Other
4
Description
There is no intervention in control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Ali Hospital
Full name of responsible person
Shahin Elyasianfar
Street address
CCu ,Emam Ali Hospital,Boulevard Shahid Beheshti
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Reza Pourmirza Kalhori
Position
Ms.of Nursing training
Other areas of specialty/work
Street address
First of Dolatabad Boulvard,Eisar Square
City
Kermanshah
Postal code
Phone
+98 83 1827 9304
Fax
Email
pourmirza@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)