Protocol summary

Study aim
Comparison of information sharing with Mobile and Electronic Board on Anxiety, Stress and Coping skills of Family members of Patients undergoing Coronary Artery Bypass graft Surgery
Design
randomised controlled trial. 80 main carers of patients undergoing CABG surgery will participate in this study. in order to randomization, the researcher will produce 80 cards, and write C letter on 40 card and M letter on another 40 cards. then the researcher will offer these cards to the participants to randomly select one card among them. if the participant pick up M card, he or she will allocate to the intervention group, and if the participant pick up C card, he or she will allocate to the control group.
Settings and conduct
This study was conducted in 2012 in Neurosurgery and Operating Room of Ayatollah Kashani Hospital in Shahrekord.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1) Patient is on the list of coronary artery bypass grafts. 2) One of the family members of the patient who plays the main role of supporting the patient at the hospital and after discharge. 3) At least 18 years of age. 4) Not having a history of coronary artery bypass graft surgery, as well as having no history of accompanying patients undergoing coronary artery bypass graft surgery 5) Ability to speak and understand Persian language 6) No history of psychological problems or recognized anxiety and stress disorder based on history and self-declaration 7) Not a member of the healthcare team. 8) Reading literacy (for understanding and reading content on the electronic board) 9) Absence of vision or hearing impairment for the ability to see the electronic board or conversation with the cell phone 10) Having the ability to work with cell phones at the time of making calls (dialing and answering) 11) The desire to collaborate with research 12) Presence from the beginning to the end of the surgery in the waiting room Exit criteria: 1. Lack of motivation of the patient's family to continue cooperation 2. Patient's death during surgery 3. Removal of electrical wiring during surgery for any reason 4. Disturbance on mobile lines and the impossibility of making phone calls
Intervention groups
in the intervention group, after the patient entered the operating room, a mobile phone will be given to the participant and the researcher will give detailed information about patient's condition in the operating room, every hour. for control group, only patient's information including name, doctor and his location in the operating room (recovery room,..) displays on the electronic board. this job is done by operating room personnel and the researcher don't have any role in them.
Main outcome variables
anxiety stress coping skills

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100511003912N9
Registration date: 2018-02-23, 1396/12/04
Registration timing: registered_while_recruiting

Last update: 2018-02-23, 1396/12/04
Update count: 0
Registration date
2018-02-23, 1396/12/04
Registrant information
Name
Kobra Nourian
Name of organization / entity
Sharekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 5648
Email address
noorian@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Information Sharing by Mobile and Electronic board on psychological symptoms of Family members of Patients undergoing Surgery
Public title
Effect of Information Sharing to family member of patients undergoing surgery on thier psychological symptoms
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patient is on the list of coronary artery bypass grafts. the family member that has the key role in caring of the patient. At least 18 years of age. Not having a history of coronary artery bypass graft surgery, as well as having no history of accompanying patients undergoing coronary artery bypass graft surgery. Ability to speak and understand Persian language. No history of psychological problems or anxiety and stress disorders known based on history and self-declaration. Not be a member of the healthcare team. Reading literacy، (to understand and read content on the electronic board). having no visual and hearing impairment Having the ability to answer phone calls and make calls desire to particapate in this research
Exclusion criteria:
Failure to motivate the patient's family to continue working. Patient death during surgery. Disconnect the electrical circuit during surgery for any reason. Disturbing cellular lines and impossibility to make phone calls.
Age
From 18 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
The executor made 80 cards, with 40 of them (M) meaning "intervention" and "40" (C) means control, and the master allowed the card to be selected and participated in the program in the control group. Took
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
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Kashani Blvd., Headquarters of the University
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2017-09-23, 1396/07/01
Ethics committee reference number
IR.SKUMS.Rcc.154

Health conditions studied

1

Description of health condition studied
Coronary Artery Bypass Grafting
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Anxity score in Spielberger Anxiety Inventory
Timepoint
before intervention and after the end of surgery
Method of measurement
Spielberger Anxiety Inventory

2

Description
Stress score in Perceived Stress Questionnaire
Timepoint
before intervention and after the end of surgery
Method of measurement
Perceived Stress Questionnaire

3

Description
Coping skills in Blingens & Moos Coping Skills Questionnaire
Timepoint
before intervention and after the end of surgery
Method of measurement
Blingens & Moos Coping Skills Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: in the intervention group, after the patient entered the operating room, a mobile phone will be given to the participant and the researcher will give detailed information about patient's condition in the operating room, every hour.
Category
Other

2

Description
Control group: for control group, only patient's information including name, doctor and his location in the operating room (recovery room,..) displays on the electronic board. this job is done by operating room personnel and the researcher don't have any role in them.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital
Full name of responsible person
Afsaneh Fazel
Street address
Ayatollah Kashani Hospital, Nursing Street
City
Sharekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Phone
+98 38 3226 4828
Fax
+98 38 3222 8600
Email
afsane.fazel@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Kamal Solati
Street address
Vice chancellor for research & technology, Kashani Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Fax
+98 38 3334 9506
Email
kamal_solati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Afsaneh Fazel
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahrekord University of Medical Sciences, Faculty of Nursing and Midwifery, Rahmatieh
City
Shahrekod
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 383224225
Email
afsane.fazel@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Kobra Noorian
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahrekord University of Medical Sciences, Faculty of Nursing and Midwifery, Rahmatieh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 5648
Email
nooriandehkordy@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Kobra Noorian
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahrekord University of Medical Sciencesو Faculty of Nursing and Midwifery, Rahmatieh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 5648
Fax
Email
nooriandehkordy@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
there are No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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