The effect of planned family member’s presence of coronary critical care inpatients on family member′s anxiety and their perception about nurses’ caring behavior
The main objective: Determining the effect of planned family member’s presence of coronary critical care inpatients on family member′s anxiety and their perception about nurses’ caring behavior
Type of research: Clinical trial
Research population: Family member's of coronary critical care inpatients
Research sample: The selected eligible first degree family member of patients
Inclusion criteria: First degree family member; Age 18 to 60 years; Lack of known psychological disease; Lack of thyroid disease; No history of hospitalization in intensive care (the family member or the patient); Do not belong to health care team
Exclusion criteria: Discontinue to participate in the study; Disturbing the ward discipline; Interference with patient care programs; Impossible continuous participation throughout the process of data collection; Dying the patient during the data collection process; The patient discharge or transfer to another department during the data collection process; Occurrence special events to the patient like CPR or intubation
Method: This study is a clinical trial. Qualified samples will be selected by convenience sampling and randomly (toss a coin) divided into control and intervention groups.
In intervention group, the presence of selected family member is planned. It means one of first degree family members of patient that is constant is selected according to patient's preference and she/he should have eligible criteria. The selected family member can be present in the ward twice per day for two days and 15 minutes in each turn. The family member is allowed to perform some patient's primary care such as dressing, washing face, eating, going patient to the bathroom, hair brushing,teeth brushing, etc. In the control group, family member can just visit the patient according to the policy of hospital that is a limited and strict schedule of visiting without any permission for doing any patient's care. The dependent variables are anxiety and perception of nurse's caring behavior which will evaluate by Spielberger's questionnaire and the caring behavior inventory (CBI-24), respectively. The questionnaires will be completed before intervention (at the first day of patient hospitalization) and after intervention (at the end of third day) in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016041727442N1
Registration date:2016-07-11, 1395/04/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-07-11, 1395/04/21
Registrant information
Name
Seyyedeh Halimeh Kamali
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 4208 7245
Email address
h-kamali@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Tehran University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of planned family member’s presence of coronary critical care inpatients on family member′s anxiety and their perception about nurses’ caring behavior
Public title
The effect of family member’s presence of CCU patients on anxiety and perception's of family about nursing care
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: First degree family member; Age 18 to 60 years; Lack of known psychological disease; Lack of thyroid disease; No history of hospitalization in intensive care (the family member or the patient); Do not belong to health care team
Exclusion criteria: Discontinue to participate in the study; Disturbing the ward discipline; Interference with patient care programs; Impossible continuous participation throughout the process of data collection; Dying the patient during the data collection process; The patient discharge or transfer to another department during the data collection process; Occurrence special events to the patient like CPR or intubation
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Qualified samples will be selected by convenience sampling and randomly (toss a coin) divided into control and intervention groups
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran Univerity of Medical Sciences
Street address
Keshavarz Bluv., Qods St., Central Building of Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2016-05-07, 1395/02/18
Ethics committee reference number
IR.TUMS.REC.1395.2560
Health conditions studied
1
Description of health condition studied
Coronary Artery Disease
ICD-10 code
100-199
ICD-10 code description
Ischaemic heart diseases
Primary outcomes
1
Description
Anxiety
Timepoint
Before intervention and at the end of third day
Method of measurement
Spielberger's state Anexiety Scale
2
Description
Perception of nurses’ caring behavior
Timepoint
Before intervention and at the end of third day
Method of measurement
Caring behavior inventory-24 items (CBI-24)
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group, the presence of selected family member is planned. It means one of first degree family members of patient that is constant is selected according to patient's preference and she/he should have eligible criteria. The selected family member can be present in the ward twice per day for two days and 15 minutes in each turn. The family member is allowed to perform some patient's primary care such as dressing, washing face, eating, going patient to the bathroom, hair brushing,teeth brushing, etc.
Category
Other
2
Description
In the control group, family member can just visit the patient according to the policy of hospital that is a limited and strict schedule of visiting without any permission for doing any patient's care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Seyyedeh Halimeh Kamali
Street address
City
Ghaemshahr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Yunesian
Street address
Keshavarz Bluv., Qods St., Central Building of Tehran University of Medical Sciences
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 Tehran University of Medical Sciences