Study on the Effectiveness of Fordyce Happiness Training on Life Expectancy in Candidate Patients for Coronary Artery Bypass Graft
Design
Clinical trial with control group, with parallel groups, without blindness, randomised,with 72 patients. The concealed randomisation sequence is used for randomisation.
Settings and conduct
For patients before coronary artery bypass grafting hospitalized in surgery wards of Heshmat hospital in Rasht ,group sessions including 6 group with 6 individuals will completed Miller questionnaire at 7 days prior to cardiac surgery. For patients of the Fordyce Happiness Model Training Intervention Group, 7 days before surgery by a psychologist will perform a daily session for 20-30 minutes for seven sessions. Immediately after the seventh session, Miller's life expectancy questionnaire will be completed again.
Participants/Inclusion and exclusion criteria
Inclusion criteria : 1. Age between 65-20 years 2.Having a minimum literacy of reading and writing 3. Lack of visual and auditory impairment 4. Being undergoing heart surgery for the first time 5. Be able to discuss in training sessions 6. Lack of depression and anxiety disorders based on the patient's history and case 7. Being aware of time and place
Intervention groups
Eligible individuals are randomly assigned to the 2 groups according to block randomized allocation.The first group, the group that is undergoing fordyce happiness training;The second group, the group without any interventions and just receives routin nursing care.
Main outcome variables
Life expectancy
General information
Reason for update
Acronym
FHT(Fordyce Happiness Training)
IRCT registration information
IRCT registration number:IRCT20180205038626N6
Registration date:2020-06-22, 1399/04/02
Registration timing:retrospective
Last update:2020-06-22, 1399/04/02
Update count:0
Registration date
2020-06-22, 1399/04/02
Registrant information
Name
Zahra Ahmadnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3361 8177
Email address
zahmadnia@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-04, 1398/05/13
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study on the Effectiveness of Fordyce Happiness Training on Life Expectancy in Candidate Patients for Coronary Artery Bypass Graft
Public title
Effect of Fordyce Happiness Training in Candidate Patients for Coronary Artery Bypass Graft
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1. Age between 65-20 years
2. Having a minimum literacy of reading and writing
3. Lack of visual and auditory impairment
4. Being undergoing heart surgery for the first time
5. Be able to discuss in training sessions
6- Lack of depression and anxiety disorders based on the patient's history and file
7. Being aware of time and place
Exclusion criteria:
1) Patient dissatisfaction for continuing to participate in the study
2) Mental retardation
3) Having education in psychology and related fields
4) History of participating in the happiness model training course
5) History of the new crisis such as the death of first-degree relatives, divorce or parenthood in the last 6 months
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Based on random blocks method and considering 6 blocks, 6 blocks will be produced for 36 patients.After providing the list, a special code is assigned to each person, and for the application of concealment, sealed envelopes that are numbered orderly will be used.
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 Guilan University of Medical Sciences
Street address
Rasht, Namjoo Ave., Shahid Siadati St., Faced to the 17th Shahrivar Hospital, Old Building, School of Health, University of Technology Research and Technology
City
Rasht
Province
Guilan
Postal code
41446-66949
Approval date
2019-08-03, 1398/05/12
Ethics committee reference number
IR.GUMS.REC.1398.227
Health conditions studied
1
Description of health condition studied
Coronary Artery Bypass Graft
ICD-10 code
T82.9
ICD-10 code description
Unspecified complication of cardiac and vascular prosthetic device, implant and graft
Primary outcomes
1
Description
Life Expectancy
Timepoint
7 days before open heart surgery and immediately after the seventh session of the Fordays Happiness Model Training
Method of measurement
Miller Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The Fordayes Happiness Model will be taught 7 days before surgery, every day for 20-30 minutes, through a psychologist for seven sessions.The content of the sessions will be about the first session: Introduction and description of goals, the second session: teaching collective activities, the third session: removing worries and lowering expectations, the fourth session: teaching positive and optimistic thinking, the fifth session: cultivating healthy and social personality, the sixth session:Leaving negative emotions, Session 7: sincere communication teaching and prioritizing happiness.
Category
Lifestyle
2
Description
Control group: No sessions and only routine nursing care
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Heshmat Rasht Hospital
Full name of responsible person
Seyedeh Shiva Modallalkar
Street address
Dr. Heshmat Rasht Hospital -Masala Square, Baniyan St.
City
Rasht
Province
Guilan
Postal code
41939-55588
Phone
+98 31 3361 8177
Fax
+98 31 3361 8177
Email
Modallalkars@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammadreza Naghipour
Street address
Namjoo Ave., Shahid Siadati St., Rasht., Technology & Research Vice-chancellor of University
City
Rasht
Province
Guilan
Postal code
41446-66949
Phone
+98 31 3333 2058
Fax
+98 31 3333 2058
Email
naghi@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Seyede shiva Modallalkar
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Dr. Heshmat Rasht Hospital -Masala Square, Baniyan St.
City
rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3361 8177
Email
modallalkars@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
seyede shiva Modallalkar
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Dr. Heshmat Rasht Hospital -Masala Square, Baniyan St
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3361 8177
Email
modallalkars@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Seyede shiva Modallalkar
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Dr. Heshmat Rasht Hospital -Masala Square, Baniyan St
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3361 8177
Email
modallalkars@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available