The purpose: Promoting the quality of sleep in coronary patients using eyelid, ear plug and music. 2) Design: 75 patients staying in CCU due to acute coronary are divided in to 3 groups: A) Control group. B) Eyelids & ear plugs group. C) Music group.
3) Direction: The patients get acquainted with the devices and get to know the purpose of the research, the morning after entering it. No special arrangements are taken in to consideration regarding the control group. In group B, eye lids &ear plugs are employed which are not removed until morning. In group C, music is employed. The head phones are removed when the patient falls asleep. The SMHSQ tests are given to the patients to answer in the morning.
Entering criteria: Patients suffering from acute coronary syndrome who have spent at least 2 nights in the hospital and is not satisfied with his sleep in the ward.
Excluding criteria: Major sleeping disorder, visual and auditory deficiency, sensory, neurological & psychological disorders, pulmonary edema, drug addiction, those in need of pain killers during the night due to severe pain.
Primary outcome: the quality of sleep in patients with acute coronary syndrome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013112515534N1
Registration date:2014-05-26, 1393/03/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-26, 1393/03/05
Registrant information
Name
Maryam Tolab
Name of organization / entity
Shiraz University of Medical Sciences.
Country
Iran (Islamic Republic of)
Phone
+98 71 1628 4329
Email address
tolab@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences.
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of sensory restriction and music on sleep quality in patients with acute coronary syndrome in the cardiac care units 2012 .
Public title
Comparing the effects of music and the use of eyelid and earplugs on the quality of sleep in coronary patients.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The patient: Suffers from acute coronary syndrome and is admitted in CCU; Has spent at least two nights in CCU; Is conscious and breathes spontaneously; Has no previous significant records of sleeping disorder; Does not suffer from auditory or visual disorders; Does not suffer from psychological or sensory-nervous disorders; Is not an addict; Has no records of advanced heart failure or pulmonary edema; Complains about his sleep in the ward.
Exclusion criteria: The patient: Is disinclined to continue cooperating; Has spent less than three nights in CCU; Death or an increase in the level of consciousness occurs; Has received narcotics up to four hours before intervention; Did PCI or angiography in the evening of the same day or these procedures are scheduled to be done in the following day; Needs pain killers due to feeling pain during the night; Needs various procedures during the night.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
75
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
1
Registry name
none
Secondary trial Id
none
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences Ethics Committee.
Street address
Zand street, Shiraz
City
Shiraz
Postal code
Approval date
2013-03-06, 1391/12/16
Ethics committee reference number
91/429865
Health conditions studied
1
Description of health condition studied
Low sleep quality in patients with acute coronary syndrome.
ICD-10 code
G 47.0
ICD-10 code description
Disorders of initiating and maintaining sleep[insomnias].
Primary outcomes
1
Description
The quality of sleep in coronary patients with acute coronary syndrome.
Timepoint
At least at the second consecutive night spent in CCU and one night after that, in two consecutive nights.
First intervention: The eyelids and earplugs will be given to the patients in the morning of the night of the study and the questions concerning them will be answered. In order not to interrupt the sleep of the patients, the devices are not removed during the night. The eyelids are soft and anti-allergic and are so chosen in order not to make patients feel uncomfortable. The earplugs are made of silicon and in addition to being comfortable are soundproof.
Category
Rehabilitation
2
Description
No special arrangements are taken into consideration in the control group.
Category
Rehabilitation
3
Description
Second intervention: The patient listens to the music composed based upon the frequency of sleep and is a mixture of the sounds heard in the nature. The music is played through light headphones which are removed carefully after the patient falls sleep.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Azzahra Cardiac Hospital.
Full name of responsible person
Marzie Momennasab, PHD, Professor assistant.
Street address
Shishegari three way, Shiraz.
City
Shiraz.
2
Recruitment center
Name of recruitment center
Dr.Faghihi Hospital.
Full name of responsible person
Marzie Momennasab, PHD, Professor assistant.
Street address
Zand street, Shiraz.
City
Shiraz.
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences.
Full name of responsible person
Dr.Gholamreza Hatam.
Street address
Zand street, Shiraz.
City
Shiraz.
Grant name
91/429865
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shiraz 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
Name of organization / entity
Shiraz University of Medical Sciences.
Full name of responsible person
Marzie Momennasab.
Position
PHD, Professor assistant.
Other areas of specialty/work
Street address
Zand street, Shiraz.
City
Shiraz.
Postal code
71568-34939
Phone
+98 917 189 7581
Fax
Email
mnasab48@yahoo.com; momennasab@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences.
Full name of responsible person
Marzie Momennasab.
Position
PHD. Professor assistant.
Other areas of specialty/work
Street address
Zand street, Shiraz.
City
Shiraz.
Postal code
71568-34939
Phone
+98 71 1647 4254
Fax
-
Email
mnasab48@yahoo.com; momennasab@sums.ac.ir
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences.
Full name of responsible person
Maryam Tolab
Position
Anesthesia nurse, Bachelor.
Other areas of specialty/work
Street address
Zand street, Shiraz.
City
Shiraz.
Postal code
71867-78354
Phone
+98 71 1628 4329
Fax
Email
maryam.tolab@yahoo.com; tolab@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)