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The effect of Nursing based Multifactorial intervention on sleep of hospitalized patients in Coronary care unit

Protocol summary

Summary
The current study examines the effects of multifactorial intervention to improve sleep in patients admitted to coronary care unit. This quasi-experimental study was conducted in 1390 in a hospital doctor Shariati in Iran. The study sample consisted of 60 patients were admitted to the coronary care unit that the following criteria were: Being hospitalized for at least three nights, be aware of time and place and no need for cardiopulmonary resuscitation, no medical history of neurological and psychiatric disorders, not receiving medications affecting sleep, like amphetamines, opiates at night, and if the patient is discharged in less than three days, need for CPR during the study and receiving disturbing sleep medications such as drugs, diuretics, amphetamines, opiates at night, samples were excluded. Specimens available for study were selected and control group was tested in the first and then experimental group. Nursing Based Multifactorial intervention was doing in the first three night's admission in experimental group and includes: reducing the environmental factors disturb sleep, changing care practices for sleep was not interrupted and in the control group took part in the routine caring. Sleep quality was measured by Pittsburgh questionnaire. With the analyzing of data in both groups, significant improvement in the experimental group is expected to sleep.

General information

Acronym
The effect of Nursing interventions on sleep of hospitalized patients
IRCT registration information
IRCT registration number: IRCT201109171599N12
Registration date: 2011-12-11, 1390/09/20
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-12-11, 1390/09/20
Registrant information
Name
Mitra Zolfaghari
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
zolfaghm@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences, Medical, Nursing and Health Care Research Center
Expected recruitment start date
2011-09-11, 1390/06/20
Expected recruitment end date
2012-01-10, 1390/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Nursing based Multifactorial intervention on sleep of hospitalized patients in Coronary care unit
Public title
The effect of Nursing based Multifactorial intervention on sleep of hospitalized patients in Coronary care unit
Purpose
Supportive
Inclusion/Exclusion criteria
The inclusion criteria of the study; Patients are admitted to the coronary care unit for at least three days; be aware of time and place; and no need for cardiopulmonary resuscitation; no medical history of neurological and psychiatric disorders; not receiving medications affecting sleep, like amphetamines, opiates and sedatives at night. Exclusion criteria of the study: Patients being discharged in less than three days; to receive sedating medications and general anesthesia; need for CPR during the study; neurological and psychiatric diseases in the patient's medical history; receiving medications affecting sleep medications such as diuretics, hypnotics, and amphetamines, opiates at night; and the patient did not wish to continue study.
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
To reduce the effects of confounding variables, research is conducted in a single CCU Dr.Shariati hospital

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
CENTER OF NURSING AND MIDWIFERY RESEARCH,Tehran University of Medical Sciences
Street address
TEHRAN UNIVERSITY OF MEDICAL SCEINCES FACUITY OF NURSING AND MIDWIFERY, SQUARE OF THOHID, TEHRAN
City
TEHRAN
Postal code
ندارد
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
1468/130/د/90

Health conditions studied

1

Description of health condition studied
Sleep
ICD-10 code
G47.8
ICD-10 code description
Other sleep disorders

Primary outcomes

1

Description
Sleep quality
Timepoint
On the first day and three days after admission
Method of measurement
Pittsburgh Questionnaire

Secondary outcomes

1

Description
Sleep quantity
Timepoint
every day for three days
Method of measurement
Researcher made ​​questionnaire

Intervention groups

1

Description
Data quality and quantity of sleep during hospitalization was measured using a questionnaire in experimental group then the intervention is conducted, including: A)Adjusting environmental factors which include: reducing the light and sound and Setting the temperature at night, B)educating nurses about the importance of sleep and sleep in patients with heart disease and insomnia factors, C)changing routine care procedures for patients to improve sleep. Then, the patient's sleep quality is measured again by using the same questionnaire three days after admission.
Category
Behavior

2

Description
Data quality and quantity of sleep during hospitalization was measured using Pittsburgh questionnaire in control group and then qualitative and quantitative characteristics of the patients with the sleep questionnaire is measured again three days after admission while routine care during in these three days for the control group was done.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Doctor Shariati Hospital
Full name of responsible person
Pouya farokh nezhad afshar
Street address
Tehran- kargar street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Nursing and Midwifery Care Research Center,Tehran University of Medical Sciences
Full name of responsible person
Mitra Zolfaghari
Street address
Nursing and Midwifery Care Research Cente, Tehran University of Medical Sciences, FACUITY OF NURSING AND MIDWIFERY, EAST NOSRAT ST, SQUARE OF THOHID, THERAN, IRAN
City
Tehran
Grant name
Phd
Grant code / Reference number
در حال بررسی
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nursing and Midwifery Care Research Center,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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Siences and Health Services
Full name of responsible person
Mitra Zolfaghari
Position
Instructor
Other areas of specialty/work
Street address
DEPARTMENT OF CRITICAL CARE NURSING, FACUITY OF NURSING AND MIDWIFERY, TEHRAN UNIVERSITY OF MEDICAL SCEINCES, EAST NOSRAT ST, THOHID SQ, TEHRAN, IRAN
City
Tehran
Postal code
1419733171
Phone
+98 216692717
Fax
Non
Email
zolfaghm@tums.ac.ir
Web page address
Non

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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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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