Protocol summary

Summary
This study had been done with the aim of determining the effect of planned visiting on sleep, hospital anxiety and depression and physiological parameters of Acute Coronary Syndrome patients in Cardiac Care Unit of Baqiyatallah hospital . Method: This is a semi-experimental study that had been done on 72 ACS patients in CCU. Samples had been chosen with base on target method sampling and had been studied randomly in two intervention and control groups in two CCUs separately. Meeting plan in, intervention group was in the form of planned and include three times meeting in the second and third day of hospitalization with the presence of on to three relatives that the patients had requested and in control group it was in the form of one time meeting per day and with the presence of some open meetings. patients sleep, anxiety and depression and physiological parameters and nurses satisfaction were recorded. Inclusion criteria: patient with acute coronary syndrome; no history of anxiety and depression; age range in 35 to 55 years old; no history of chronic heart failure and COPD; do not use of cardiac pace maker device and no history of CCU hospitalization. Exclusion criteria: cardiac arrest and CPR; need for use of cardiac pace maker device during the assessment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201204209521N1
Registration date: 2013-06-02, 1392/03/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-06-02, 1392/03/12
Registrant information
Name
Ali Rahmani
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2245 6353
Email address
rahmani@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Nursing faculty, Baqiatallah University of Medical Sciences
Expected recruitment start date
2012-09-05, 1391/06/15
Expected recruitment end date
2013-02-03, 1391/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The survey effect of planned visit on anxiety , depression, sleep and physiological factors of ACS patients in CCU wards of BUMS ,2012
Public title
The survey effect of planned visit on anxiety , depression, sleep and physiological factors of ACS patients in CCU wards of BUMS
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patient with acute coronary syndrome; no history of anxiety and depression; age renge in 35 to 55 years old; no history of chronic heart failure and COPD; do not use of cardiac pace maker device and no history of CCU hospitalization. Exclusion criteria: cardiac arrest and CPR; need for use of cardiac pace maker device durig the assessment.
Age
From 35 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 72
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
nursing faculty of baqiyatallah medical science university
Street address
aghdasieh avenue, velayat academic complex
City
tehran
Postal code
-
Approval date
2012-07-25, 1391/05/04
Ethics committee reference number
30

Health conditions studied

1

Description of health condition studied
Acute coronary syndrom
ICD-10 code
I20-25
ICD-10 code description
Ischaemic heart diseases

Primary outcomes

1

Description
Sleep
Timepoint
First, second and third day of hospitalization,
Method of measurement
Questionnaire

2

Description
Hospital depression
Timepoint
First and third days of hospitalization
Method of measurement
Hospital anxiety and depression scale

3

Description
Physiologic factors
Timepoint
Every 2 hourse in day & before, Simultaneously and after of visiting
Method of measurement
Cardiac monitoring device

4

Description
Hospital anxiety
Timepoint
First day(before intervention in case groupe) and third dayof hospitalization( after intervention in controll groupe)
Method of measurement
Hospital anxiety and depression scale

Secondary outcomes

empty

Intervention groups

1

Description
Planned visiting in case group: tree time visiting with family at second and third day of hospitalizationwith tree persons of patients relative
Category
Other

2

Description
In controll groupe dont interfere & patient received routin visiting (one time in day visiting with family in second & third days of hospitalization with open visitores
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
baqiyatahhah alazam hospital
Full name of responsible person
roza ahmadian yazdi
Street address
mollasadra avenue,southern sheikh bahaie avenue
City
tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Nursing faculty, Baqiatallah University of Medical Sciences
Full name of responsible person
Dr. Ramazan Rahmani
Street address
Aghdasieh avenue, Veladat academic complex
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nursing faculty, Baqiatallah 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
Baqiatallah University of Medical Sciences
Full name of responsible person
Roza Ahmadian Yazdi
Position
Nurse
Other areas of specialty/work
Street address
Baqiatallah University of Medical Sciences, Aghdasieh avenue
City
Tehran
Postal code
Phone
+98 21 2228 9941
Fax
Email
ahmadianroza@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Baqiatallah University of Medical Sciences
Full name of responsible person
Roza Ahmadian Yazdi
Position
Nurse
Other areas of specialty/work
Street address
Baqiatallah University of Medical Sciences, Aghdasieh avenue
City
Tehran
Postal code
Phone
+98 21 2228 9941
Fax
Email
ahmadianroza@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Baqiatallah University of Medical Sciences
Full name of responsible person
Roza Ahmadian Yazdi
Position
Nurse
Other areas of specialty/work
Street address
Baqiatallah University of Medical Sciences, Aaghdasieh avenue
City
Tehran
Postal code
Phone
+98 21 2228 9941
Fax
Email
ahmadianroza@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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