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The effect of family centered care program on anxiety of patients who admitted in Cardiac Care Unit

Protocol summary

Summary
Ischemic heart diseases are one of the important causes of admission in Coronary Care Unit (CCU). Threatening conditions of these diseases and environment of CCU can causes the anxiety in patients. Patient anxiety in CCU can cause the progress of disease, delay of recovery, and increase the mortality of disease. Therefore, appropriate interventions to decrease of the patient anxiety are one of the priorities of care in CCU. In this study three groups of patients with ischemic heart disease are selected as group 1, group 2 and group 3. In group 1, the family members receive the routine cares. In group 2, the conditions are provided that the family members, if they want, met their patients 1.5 hours per day. In group 3, the family centered care program is done after coordination with nurses, patients and family members. This program includes introducing one of the family members with CCU environment, meeting with patient and his doctor, telephone contact with family member, and giving the guide booklet to family member. Then patient anxiety is measured in admission time and after three days and is compared among three groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201105146481N1
Registration date: 2011-05-23, 1390/03/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-05-23, 1390/03/02
Registrant information
Name
Mohsen Soleimani
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
soli257@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2011-05-22, 1390/03/01
Expected recruitment end date
2011-10-23, 1390/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family centered care program on anxiety of patients who admitted in Cardiac Care Unit
Public title
Effect of family centered care program on anxiety of patients with cardiac disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1- Mental and consciousness ability to communication 2- Having the family members that follow their conditions 3- Probability of admission for more than three days. Exclusion criteria: 1- having any transferable disease through respiration or touching 2- having any threatening diseases such as shock or dangerous arrhythmias.
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, 5th Km of Damghan Road
City
Semnan
Postal code
3513138111
Approval date
2011-04-24, 1390/02/04
Ethics committee reference number
24

Health conditions studied

1

Description of health condition studied
Anxiety of patients with ischemic heart disease
ICD-10 code
I20, I21,
ICD-10 code description
Ischaemic heart diseases

Primary outcomes

1

Description
Anxiety
Timepoint
at least 3 days later
Method of measurement
spilberger anxiety test

2

Description
Anxiety
Timepoint
at least 3 days later
Method of measurement
Spielberger State Trait Anxiety Inventory

Secondary outcomes

empty

Intervention groups

1

Description
Routine interventions
Category
N/A

2

Description
presence of family members
Category
Placebo

3

Description
family centred care program
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh hospital
Full name of responsible person
Street address
17 shahrivar boulevard
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research, Semnan University of Medical Sciences
Full name of responsible person
Dr. Raheb Ghorbani
Street address
5th Km of Damghan Road
City
Semnan
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, Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Mohsen Soleimani
Position
Associated professor
Other areas of specialty/work
Street address
Nursing Faculty, Semnan University of Medical Sciences
City
Semnan
Postal code
3513138111
Phone
+98 23 1335 4190
Fax
Email
soli257@sem-ums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohsen Soleimani
Position
Associate professor
Other areas of specialty/work
Street address
Nursing faculty, Semnan University of Medical Sciences
City
Semnan
Postal code
3513138111
Phone
+98 23 1335 4190
Fax
Email
soli257@sem-ums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohsen Soleimani
Position
Associated professor
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
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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