This study will be done with the aim of investigating the effect of family presence on anxiety of acute coronary syndrome patients at cardiac care unit. Convenient samples will be used. Inclusion criteria: Acute coronary syndrome patients who are hospitalized for at least three days in cardiac care unit; The patient is alert and awake; Gaining Score higher than 20 according to speilberger questionnaire. Exclusion criteria: Discharging patient less than three days of hospitalization; Cardiopulmonary resuscitation need; Reciving hypnotic except for Alprazolam and Oxazepam; The presence of acute cardiovascular and pulmonary complications during the study. A quasi-experimental study will be started on 60 acute coronary syndrome patients and patients will be divided into two categories, after doing steps of beginning the study and obtaining approval and written consent. Speilberger questionnaire will be used for the level of anxiety evaluation. A member of family who has had close emotional relationship with the patient will be stayed beside him/her for the intervention group, from beginning until third day of hospitalization as well as usual cares. Routine cares without family presence will be done for control group. As the average time of hospitalization in cardiac care unit in this center is 72 hours, the questionnaire will be completed once in a first and the second time in third day of hospitalization. Then the effect of family presence on patient's anxiety will be assessed and compared in both groups.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2017030732939N1
Registration date:2017-09-02, 1396/06/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-02, 1396/06/11
Registrant information
Name
Leila Hatefpartovi
Name of organization / entity
Faculty of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5642 8283
Email address
hatefl@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Faculty of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of family presence on anxiety of acute coronary syndrome patients at cardiac care unit.
Public title
Effect of family presence on anxiety of acute coronary syndrome patients at cardiac care unit.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Acute coronary patients (ST Elevation MI; Non ST Elevation MI; Unstable Angina be hospitalized for at least three days in cardiac care unit; Awareness of place and time; No psychological disorder with physician's approval. Gaining score higher than 20 according to speilberger questionnaire.
Exclusion criteria: Discharging patient who is hospitalized for less than three days; Cardiopulmonary resuscitation need; Receiving hypnotic except for Alprazolam and Oxazepam which is usually prescribed by the physician; The presence of acute cardiovascular and pulmonary complications such as Acute Pulmonary Edema, Heart Failure and Angina during the study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Assignment of study groups is parallel.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences
Street address
Valiasr St, Niayesh Intersection, Across from Shahid Rajaee Hospital Faculty of Nursing and Midwifery of Shahid Beheshti University of Medical Sciencese, Tehran, Iran
City
Tehran
Postal code
1985717443
Approval date
2017-01-03, 1395/10/14
Ethics committee reference number
IR.SBMU.PHNM.1395.571
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Disorder (of) anxiety
Primary outcomes
1
Description
Anxiety
Timepoint
First and Third day of Patient's hospitalization
Method of measurement
Speilberger questionnair
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Without action/ Routine cares without family presence beside patient during the hospitalization and assessing the level of patient's anxiety in first and third day of hospitalization.
Category
N/A
2
Description
Intervention group:patient's family presence from the first day until the third day of hospitalization and assessing the level of patient's anxiety in first and third day and at last comparing with control group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
EmamReza Hospital in Eslam Shahr
Full name of responsible person
Dr. Sima Zohari Anboohi
Street address
valiasr St, Niayesh Intersection, Across from Shahid Rajaee Hospital, Faculty of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Sima Zohari Anboohi
Street address
Valiasr St, Niayesh Intersection, Across from Shahid Rajaee Hospital, Faculty of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences, Tehran, Iran
City
Tehran
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 of Shahid Beheshti 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
Faculty of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Leila Hatef Partovi
Position
M.S. Student of Nursing
Other areas of specialty/work
Street address
Valiasr St, Niayesh Intersection, Across from Shahid Rajaee Hospital; Faculty of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences, Tehran, Iran
City
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 218822521
Email
L.hatefpartovi@gmail.com; hatefl@sbmu.ac.ir
Web page address
sbnmf@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Sima Zohari Anboohi
Position
Assistant Professor of Nursing
Other areas of specialty/work
Street address
Valiasr St, Niayesh Intersection, Across from Shahid Rajaee Hospital, Faculty of Nussing and Midwifery of Shahid Beheshti University of Medical Sciences, Tehran, Iran
City
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 218822521
Email
sima_zohari@sbmu.ac.ir; simazohari@gmail.com
Web page address
sbnmf@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Sima Zohari Anboohi
Position
Assistant Professor of Nursing
Other areas of specialty/work
Street address
Valiasr St, Niayesh Intersection, Across from Shahid Rajaee Hospital, Faculty of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences, Tehran, Iran
City
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 218822521
Email
sima_zohari@sbmu.ac.ir; simazohari@gmail.com
Web page address
sbnmf@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)