1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
06 Nov 2022
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 1335 4192 Email address
soli257@sem-ums.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
2 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
3 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
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
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
