The present study will be designed with the aim of investigating the effect of positive interventions on disease perception and distress related to symptoms in heart failure patients.
Design
The clinical trial has a control group, with parallel groups, no blinding, randomized
Settings and conduct
This study will be conducted in heart failure patients of Birjand City by randomized clinical trial method. Blinding will not be done in the above study.
Participants/Inclusion and exclusion criteria
Diagnosis of heart failure by a cardiologist (EF≤40%) - at least 6 months have passed since the initial diagnosis of not suffering from acute psychiatric disorders (schizophrenia, depression) and taking psychoactive drugs - not participating in similar training courses in the last 6 months -
Intervention groups
Before the intervention, the people of the intervention group will complete the data collection tools, including the demographic information questionnaire, the disease perception questionnaire, and the distress questionnaire related to the symptoms. Then, using limited randomization, these people were assigned to two intervention and control groups. The participants of the intervention group will be divided into 2 groups based on education. Then, positive intervention training sessions will be held for eight weeks (one 90-minute session each week) for the intervention groups (2 groups). The control group will be assured that if the intervention is effective, the intervention will be done for them if they wish. Before the intervention, immediately after the intervention and two months after the end of the intervention, the study questionnaires will be completed by the patients participating in the research.
Main outcome variables
Illness perception; Symptoms distress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240506061676N1
Registration date:2024-05-19, 1403/02/30
Registration timing:prospective
Last update:2024-05-19, 1403/02/30
Update count:0
Registration date
2024-05-19, 1403/02/30
Registrant information
Name
Mohammad Esmaeelzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5672 2946
Email address
esmaeelzadehm1401@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of positive thinking interventions on illness perception and symptoms distress among heart failure patients
Public title
The effect of positive thinking interventions on illness perception and symptoms distress
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in research
ability to read and write
Age 20-65 years
No addiction (alcohol, smoking and drugs)
Not going through an emotional crisis in the last 3 months
Diagnosis of heart failure by a cardiologist (EF≤40%)
At least 6 months have passed since the initial diagnosis
Not suffering from acute psychiatric disorders (schizophrenia, depression) and taking psychoactive drugs
Not participating in similar training courses in the last 6 months.
Not having a high level of anxiety and stress based on the DASS-21 questionnaire (stress and anxiety scores should be maximum 12 and 7 respectively)
Lack of therapeutic interventions performed to manage heart disease (PCI or CABG)
Class I, II and III in the NYHA criteria
Exclusion criteria:
Unwillingness to continue participating in the study
Experiencing an emotional crisis during the intervention process by the patient
Absence in more than 2 sessions of the intervention process
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:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The limited randomization method will be used using the law of random allocation. First, 35 sealed cards for the intervention group and 35 sealed cards for the control group are prepared. These cards are placed in the draw container. Then the cards are randomly removed from the container without replacement and the created sequence is recorded. Each of the generated random sequences is recorded on a card and each card is placed inside opaque envelopes. In order to preserve the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lids of the envelopes will be glued and placed in the box respectively. For each of the participants, one of the envelopes is opened in order and the assigned group of that participant is determined.
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
Research Ethics Committees of Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences , Ghafari Street, Birjand, South Khorasan, Iran.
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۰۷۶
Approval date
2024-03-11, 1402/12/21
Ethics committee reference number
IR.BUMS.REC.1402.556
Health conditions studied
1
Description of health condition studied
Heart Failure
ICD-10 code
I50.9
ICD-10 code description
Heart failure, unspecified
Primary outcomes
1
Description
Illness Perception Score in the Brief Illness Perception Questionnaire
Timepoint
Before the intervention, immediately after the intervention, two months after the end of the intervention
Method of measurement
Brief Illness Perception Questionnaire
2
Description
Symptom Distress Score in Symptom Distress Scale
Timepoint
Before the intervention, immediately after the intervention, two months after the end of the intervention
Method of measurement
Symptom Distress Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group by the convenience method, taking into account the inclusion and exclusion criteria of those suffering from heart failure. Applicants will be selected to the specialized heart clinic in Razi Hospital in Birjand City. These people will complete the data collection tools including a demographic information questionnaire, disease perception questionnaire, and distress questionnaire related to symptoms. Then, using simple permutation blocking, these people were assigned to two intervention and control groups. The participants of the intervention group will be divided into 2 groups based on education. Then, positive intervention training sessions will be held for eight weeks (one 90-minute session each week) for the intervention groups (2 groups). Before the intervention, immediately after the intervention and two months after the end of the intervention, the study questionnaires will be completed by the patients participating in the research
Category
Behavior
2
Description
Control group: The control group will be the type of control group in the waiting list, so that the control group will be assured that if the intervention is effective, the intervention will be done for them if they wish.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Mohammad Esmaeelzadeh
Street address
Razi Hospital , Ghafari Street, Birjand, South Khorasan, Iran.
City
Birjand
Province
South Khorasan
Postal code
9717853111
Phone
+98 56 3162 6000
Email
razihospital@bums.ac.ir
Web page address
https://razi.bums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Masoud Yousefi
Street address
Birjand University of Medical Sciences , Ghafari Street, Birjand, South Khorasan, Iran.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5696
Email
international@bums.ac.ir
Web page address
https://en.bums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Seyyed Abolfazl Vagharseyyedin
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Birjand University of Medical Sciences , Ghafari Street, Birjand, South Khorasan, Iran
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۰۷۶
Phone
+98 56 3239 5000
Email
Waghars@bums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Seyyed Abolfazl Vagharseyyedin
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Birjand University of Medical Sciences , Ghafari Street, Birjand, South Khorasan, Iran
City
Birjand
Province
South Khorasan
Postal code
9717853076
Phone
+98 56 3239 5000
Email
Waghars@bums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Esmaeelzadeh
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 119, Moalem Blvd
City
Feyzabad
Province
Razavi Khorasan
Postal code
9531735206
Phone
00955156722946
Email
Mohammadesmailzade01@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 further 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
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