Determining The effect of intervention based on illness perception on death anxiety and coping in patients with heart failure in zanjan educational hospitals
Design
Clinical trial with control group, with parallel groups, one-way blind, randomized, on 120 patients, randomized using random minimization method
Settings and conduct
This study was performed in the CCU and heart wards of Ayatollah Mousavi Hospital in Zanjan. If there were inclusion criteria and after obtaining written consent from the subjects , individuals were randomly divided into two groups of intervention and control. Patients were blind to the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: definitive diagnosis of heart failure by a cardiologist; Having an EF (ejection fraction) equal to or less than 40% on echocardiography;
Having a stable status in terms of hemodynamics and clinical conditions; Having satisfaction with the study; Being at least 35 years old; Must be alert and aware of time and place; Having the ability to complete a questionnaire and Participating in meetings physically and clinically; Not to be under others study.Exclusion criteria:History of death of loved ones in recent months
; Have a known mental illness and be treated with drugs that affect the psyche.
Intervention groups
In the intervention group, an intervention based on correcting the illness perception was performed during 3 sessions of 30 minutes individualy based on each patient's response to the summarized questionnaire of illness perception. In the control group, no intervention was performed by the researcher and patients received only routine hospital care.
Main outcome variables
illness perception; death anxiety; coping
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201020049083N1
Registration date:2020-12-02, 1399/09/12
Registration timing:retrospective
Last update:2020-12-02, 1399/09/12
Update count:0
Registration date
2020-12-02, 1399/09/12
Registrant information
Name
Negin Babaeivahed
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3341 2451
Email address
nbabaivahed69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-27, 1398/12/08
Expected recruitment end date
2020-05-28, 1399/03/08
Actual recruitment start date
2020-06-05, 1399/03/16
Actual recruitment end date
2020-09-20, 1399/06/30
Trial completion date
2020-09-20, 1399/06/30
Scientific title
The effect of intervention based on illness perception on death anxiety and coping in patients with heart failure
Public title
The effect of intervention based on illness perception on death anxiety
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of heart failure by a cardiologist
Having an EF (ejection fraction) equal to or less than 40% on echocardiography
Having a stable condition in terms of hemodynamics and clinical conditions
Having Satisfaction with participation in the study
To have at least 35 years old
The patient must be alert and aware of time and place.
Having the ability to complete the questionnaire and participate in sessions physically and clinically
Having ability to understand Persian language to complete the questionnaire
Not to be under others study
Exclusion criteria:
Have a known mental illness and take medication that affects the psyche.
history of death of loved ones in recent months
Age
From 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 120 patients are selected using the available sampling method and then the patients are assigned to the intervention (training) and control groups using the random sampling method. Age and gender variables are grouping variables in this allocation method. In this way, the first person is selected through a random method (coin toss) and the next people who enter the study are selected based on a table of random numbers, respectively, and considering the allocation protocol of the minimization method, treatment is assigned to them.
Blinding (investigator's opinion)
Single blinded
Blinding description
Because patients are unaware of the educational intervention process, they are blind to the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Science, Azadi Square
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2020-02-08, 1398/11/19
Ethics committee reference number
IR.ZUMS.REC.1398.456
Health conditions studied
1
Description of health condition studied
Heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
Illness perception
Timepoint
Before intervention, After 3 sessions of intervention
Method of measurement
Brief of illness Perception Questionnaire (BIPQ)
Secondary outcomes
1
Description
Death anxiety
Timepoint
Before the intervention, after 3 sessions of intervention
Method of measurement
Templer Death Anxiety Questionnaire
2
Description
Coping
Timepoint
Before the intervention, after 3 sessions of intervention
Method of measurement
A brief questionnaire of coping
Intervention groups
1
Description
Intervention group: An intervention based on correcting the perception of the disease was performed individually and during face-to-face interviews based on each patient's response to the Summary Perception of the Disease Questionnaire (BIPQ) during 3 30-minute sessions during hospitalization. Correction of disease perception in these 3 sessions was based on the Leventhal self-regulatory model, which provides knowledge of the disease based on 5 components including description of the nature of the disease, related symptoms and causes, disease outcomes, disease course, and control / treatment.The educational booklet compiled by the researcher was presented to the patients at the end of the third session.
Category
Prevention
2
Description
Control group:No intervention was performed in this group and patients received only routine hospital care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital
Full name of responsible person
Negin Babaeivahed
Street address
Gavazang Road, Ayatollah Mousavi Hospital
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 3313 0000
Fax
+98 24 3313 1203
Email
mousavihospital@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Alireza Shogli
Street address
Vice-Chancellery for Research, Zanjan University of Medical Science
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3301 8000
Email
Nbabaivahed69@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Mahin Roohani
Position
M.S of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Zanjan University of Medical Sciences, shahrak karmandan, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 3314 8357
Email
Roohani@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mahin Roohani
Position
M.S of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Zanjan University of Medical Sciences, shahrak karmandan, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 3314 8357
Email
Roohani@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Negin Babaeivahed
Position
Master student of intensive care nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Zanjan University of Medical Sciences,Haj Ahmad Mahdavi Street, shahrak karmandan, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 3314 8357
Email
Nbabaivahed69@gmail.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 is no more information
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