Protocol summary

Summary
Main Goals: To determine the effect of Nursing Measures on patients’ sleep quality who are hospitalized in the CCU Heart ward of Ekbatan Hospital in Hamadan city. To design the study: calculated one Population to study: all hospitalized patients in CCU Wards of Ekbatan Hospital Criteria to enter the Study: • Hospitalized in CCU • No sign of sleep disorder before admission • Having alertness & Orientation Criteria to exit the Study: • Discharging before day 3 • Losing consciousness • Clinical Deterioration of the patient Sample Size: 166 Patients Measures taken into study: • Assessing the sleep quality of Control Group • Educating Nursing Measures developed for a proper Sleep e.g., Environment Factor Control, providing Nursing and Medical Interventions at the right time, Pain and Stress alleviation, not using any Diuretics before sleeping time, assessing the Sleep Quality of Control Group after receiving Nursing Measures. Intervention time: The Sleep Quality of Control Group has to be checked on the third morning upon admission. After reaching the samples to the desired level, the required changes in the ward and educating nurses are proceeded during 10 days. Later, the Sleep Quality of group three hospitalized is checked through questionnaires. It is noticed that 10 minutes should be assigned to fill the questionnaires. Study Outcome: • Sleep quality of patients

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012091010803N1
Registration date: 2012-11-06, 1391/08/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-11-06, 1391/08/16
Registrant information
Name
Mahnaz Moghadari Koosha
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0150
Email address
m.moghadarikoosha@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vic-chancellor of Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2012-11-05, 1391/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To determine the effect of Nursing Measures on patients’ sleep quality who are hospitalized in the CCU Heart ward of Ekbatan Hospital in Hamadan city, 1391".
Public title
Evaluation the effect of Nursing Measures on patients’ sleep quality who are hospitalized in the CCU ward
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Hospitalized in CCU; No sign of sleep disorder before admission; Having alertness & Orientation Exclusion Criteria: Discharging before day 3; Losing consciousness; Clinical Deterioration of the patient
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 166
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the Hamadan University of Medical Sciences
Street address
Shahid fahmide avenue, Hamadan University of Medical Sciences
City
Hamadan
Postal code
6517838695
Approval date
2012-08-13, 1391/05/23
Ethics committee reference number
1838/9/35/16/پ/د

Health conditions studied

1

Description of health condition studied
heart disease
ICD-10 code
Y84.0, Z50
ICD-10 code description
Cardiac catheterization, Cardiac rehabilitation,Cardiac arrest with successful resuscitation,Other cardiac arrhythmias,Paroxysmal tachycardia, Atrial fibrillation and flutter,Acute myocardial infarction, Subsequent myocardial infarction,Old myocardial inf

Primary outcomes

1

Description
sleep qulity
Timepoint
before intervention, 2week after intervention.
Method of measurement
SMHSQ questionnaire

Secondary outcomes

1

Description
Nursing measures
Timepoint
before intervention, after intervention
Method of measurement
questionnaire made by scholar

Intervention groups

1

Description
Control Group receives the routine Nursing Care in CCU Ward. It means that no changes will be applied in the ward and no training will be given to staff as well.
Category
Other

2

Description
After sampling the Control Group, Nursing measures are trained to nurses in 10 days, including environment factor Control like sound reduction by speaking softly, using silent Shoes, replacing damaged chairs, preparing medications in the treatment room, applying phones with flashes instead of rings, changing worn trolleys , modulating lights and temperature. Furthermore, other measures are; providing Nursing and Medical measures at the right time, relieving pain, averting stress and using no diuretics close to sleep time. Finally, after implementing Nursing Measures, in the morning of the third day of admission, the quality of Sleep of the participated/case Group will be measured via SMHSQ .
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ekbatan Hospital in Hamadan city
Full name of responsible person
Mahnaz Moghadari Koosha
Street address
Taleghani avenue, Jahad field
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Ahmad Tavilani
Street address
Shahid Fahmide avenue
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Hamadan 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
Research Center for Health Sciences, Department of Epidemiology & Biostatistics
Full name of responsible person
Dr Javad Faradmal
Position
MD, PhD, Assistant Professor of Stats
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Phone
+98 81 1838 0090
Fax
Email
j80f@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Internal Medicine and Surgery, Nursing and Midwifery School
Full name of responsible person
Dr Khodayar Oshvandi
Position
Phd
Other areas of specialty/work
Street address
Department of Internal Medicine and Surgery, Nursing and Midwifery School, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Phone
+98 81 1838 0150
Fax
Email
oshvandi2004@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nursing and Midwifery School
Full name of responsible person
Dr Khodayar Oshvandi
Position
Phd, Assistant
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shaheed Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 1838 0150
Fax
Email
oshvandi2004@yahoo.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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