This study is performed to evaluate the effect of supportive nursing program for patient’s family members under depression, anxiety and stress during coronary artery bypass graft surgery (CABG). This semi-experimental study is conducted on 52 patient’s family members in different groups considering the inclusion criteria. Inclusion Criteria includes having main role in supporting patient, Be at least 18 years of age, have no study in medical science and Ability to understand Persian conversation. Exclusion Criteria includes Lack of family member of patient cooperation in data collection and patient's surgery take longer than usual like sever bleeding, unexpected problem or patient death. The experimental group members will be provided with supportive nursing program including informational and emotional support. The members of the control group also will be received routine intervention. Data will be collected by demographic and modified Depression Anxiety and Stress (DASS) questionnaires.The questionnaires will be given to the family member at the the beginning and end of surgery and level of depression, anxiety and stress will be compared in control and intervention group.
General information
Acronym
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IRCT registration information
IRCT registration number:IRCT201404034443N10
Registration date:2014-06-27, 1393/04/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-27, 1393/04/06
Registrant information
Name
Masoumeh Zakerimoghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2286 2160
Email address
zakerimo@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2014-07-21, 1393/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of supportive nursing program on depression anxiety and stress of family member of patient during coronary artery bypass surgery
Public title
The effect of supportive nursing program on depression anxiety and stress of family member of patient during coronary artery bypass surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria : have main role in supporting patient; Be at least 18 years of age; have no study in medical science; Ability to understand Persian conversation; The absence of mental illness.
Exclusion Criteria: Lack of family member of patient cooperation in data collection; patient's surgery take longer than usual ( like sever bleeding, unexpected problem or patient death).
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
104
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
Tehran University of Medical Sciences
Street address
Sixth Floor, Central Organization of University, Qods St, Keshavarz Blvd
City
Tehran
Postal code
1419733171
Approval date
2014-03-15, 1392/12/24
Ethics committee reference number
130/3020/د/92
Health conditions studied
1
Description of health condition studied
family member during coronary artery by pass graft
ICD-10 code
Z63.8
ICD-10 code description
سایر مشکلات ویژه مربوط به گروه مرافبت اولیه
Primary outcomes
1
Description
depression anxiety and stress
Timepoint
before surgery and after surgery
Method of measurement
Depression Anxiety Stress Scales (DASS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: The intervention in this study is supportive nursing program for patient’s family members.This Program will be started in the beginning of surgery and continue until the end of surgery. The first part is about informational support that includes talk to patient's family and adequately informed about patient's condition and process of surgery, answer to questions of family and report patient situation every thirty minutes, in emotional support the family member
encourage to talking about concerns and fears
, expression of feeling, assurance that the best possible care is provided to their patient and in the third part for personal support private place for communication with family will be provided.
Category
Other
2
Description
Control group: Will receive routine intervention
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiac Research, Educational and Treatment Center of Shahd Rajaee
Full name of responsible person
Pegah Salahshoor
Street address
end of Niayesh Highway, Vali-asr Ave.,
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
research assistant of university Dr.Footoohi
Street address
tehran-keshavarz bolvare-ghods street-central Building
City
Tehran
Grant name
-------
Grant code / Reference number
--------
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Masoumeh Zakerimoghadam
Position
Senior expertise/Scientific Panel member
Other areas of specialty/work
Street address
Tehran-tohid Square-Eastern nosrat-School of Nursing and Midwifery
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
zakerimo@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoumeh Zakerimoghadam
Position
Senior expertise/Scientific panel member
Other areas of specialty/work
Street address
Tehran-tohid Square-Eastern nosrat-School of Nursing and Midwifery
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
zakerimo@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoumeh Zakerimoghadam
Position
senior expertise/Scientific panel member
Other areas of specialty/work
Street address
Tehran-tohid square-eastern nosrat-school of nursing and midwifery
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
zakerimo@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)