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Comparative study of the effect of white noise, earplug and Instrumental music on sleep in CCU patients

Protocol summary

Summary
The aim of this study is comparing the influence of white music, earplug, music without lyrics on patients’ sleeping who were in CCU. This study is done in 2014 with 144 participants. They were hospitalized in C.C.U. in Tehran University of Medical Sciences hospitals. These participants had these characteristics. being in C.C.U at least for three nights because of coronary syndrome, obtaining score 5 or higher in sleeping quality questionnaire (sleeping disorder); homodynamic stability; not taking addictive drugs 5 or 6 hours before sleeping; not taking any anti-depressants, inotrope, amphetamine during the night; not having hearing disorder and not using ways affecting sleeping. Participants were put in control and experimental group randomly. Participants having sever problems were out of study. The problems were as follows; homodynamic instability, unconsciousness, need to mechanical ventilation, cardiac pulmonary arrest. Patients in experimental group, received white music, earmuffs, music without lyrics that induces sleep. In order to measure quality and quantity of patients sleeping in this study. Petersburg sleeping quality questioners, Demographics form, sleeping quantity questioners(sleep log) are used and then 4groups are compared with each other.

General information

Acronym
Sleep and cardiac patients
IRCT registration information
IRCT registration number: IRCT201403138286N4
Registration date: 2014-09-15, 1393/06/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-09-15, 1393/06/24
Registrant information
Name
Fatemeh Bahramnezhad
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
fatemeh_bahramnezhad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-07-01, 1393/04/10
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of white noise, earplug and Instrumental music on sleep in CCU patients
Public title
Comparative the effect of white noise, earplug and Instrumental music on sleep in Cardiac patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: willing to cooperate and complementing a questionnaires; obtaining score 5 or higher in sleeping quality questionnaire (sleeping disorder); being at least 30 years old; being in C.C.U at least for three nights because of coronary syndrome; time and place awareness; homodynamic stability; no breathing problem; having no surgery; not taking addictive drugs 5 or 6 hours before sleeping; not taking any anti-depressants; inotrope; amphetamine during the night. Not taking nerve drugs; not having obvious sleeping disorder; not having brain disorder; not having hearing disorder; not having maladies affecting sleeping such as migraine and Arthritis rheumatoid; not using effective methods of sleep. Exclusion criteria: unwillingness to cooperate and completing questionnaires; appearance of sever problems e.g. hemodynamic instability, unconsciousness, mechanical ventilation, cardiac pulmonary arrest, during the study; leaving hospital before 3 days; emergency prescribed drugs such as addictive drug, anesthesia drug, diuretics, anti-depressants, inotrope, sedative and amphetamine during the night.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 144
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

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Review Commiitee of Tehran University of Medical Sciences
Street address
Central Building, Tehran University of Medical Sciences, Qods St., Keshavarz Blvd.
City
Tehran
Postal code
-
Approval date
2014-06-18, 1393/03/28
Ethics committee reference number
130/673/د/93

Health conditions studied

1

Description of health condition studied
Heart disease(acute coronary system)
ICD-10 code
I20-I25
ICD-10 code description
Ischaemic heart diseases

Primary outcomes

1

Description
Sleep quantity
Timepoint
In this study, sleeping quantity in starting of sleeping, when they are awake or nap, and sleeping hours in the first day in hospital and during these 3 days are measured
Method of measurement
Sleeping quantity questioners(sleep log)

2

Description
Sleep quality
Timepoint
In the first day of hospital and 3 days after that
Method of measurement
Petersburg questioner

Secondary outcomes

empty

Intervention groups

1

Description
Experimental groups (white noise,ear plug and instrumental music) measuring quality and quantity of patients in the past in the first day of hospitalization . playing and using white noise (sound of ocean), ear plug and a music with no lyrics for 45 minutes at night. measuring sleeping quantity of patients every three day through Sleep Log sleep quantity index. measuring sleeping quality of patients at the end of day three through Petersburg sleep quality index.
Category
Treatment - Other

2

Description
control group, measuring the previous quantity and quality of patients’ sleeping during last month through Petersburg sleeping quality index and sleeping quantity index (sleep log). Not recive disturbance for patients and recive rotin care during these three nights. Measuring sleeping quantity through sleeping quantity index (sleep log) during three days. Measuring sleeping quality through Petersburg sleeping quality index at the end of day three.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Mohammad Ali Cheraghi
Street address
Dr Garib St.
City
Tehran

2

Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Mohammad Ali Cheraghi
Street address
Tehran- Shariati Hospital
City
Tehran

3

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Mohammad Ali Cheraghi
Street address
Tehran-Sina Hospital
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoud Younesian
Street address
Central Building, Tehran University of Medical Sciences, Qods St., Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Khadijeh Akbari
Position
Master styudent of nursing
Other areas of specialty/work
Street address
Nursing & Midwifery School, East Nosrat st., Tohid sq.,
City
Tehran
Postal code
Phone
+98 935 544 8676
Fax
Email
akbarikh2013@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Cheraghi
Position
PhD in Nursing ( Associate Professor)
Other areas of specialty/work
Street address
Nursing & Midwifery School, East Nosrat st., Tohid sq.,
City
Tehran
Postal code
Phone
+98 21 6105 4128
Fax
Email
mcheraghi@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Khadijeh Akbari
Position
Master student of nursing
Other areas of specialty/work
Street address
Nursing & Midwifery School, East Nosrat st, Tohid sq
City
Tehran
Postal code
Phone
Fax
Email
akbarikh2013@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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