Protocol summary

Study aim
Determining the effectiveness of an Audio Psycho-education Package based on Bioenergy economy with Emphasis on forgiveness on improving life quality and vegetative indicators of coronary heart patients
Design
Clinical trial with control group, without blinding, randomized
Settings and conduct
Coronary patients referring Allameh Behlool Hospital in Gonabad were assigned to two control and experimental groups. The experimental group was trained in 8 sessions with audio podcasts. Patients were asked to do the exercises of each session available to them in the Telegram group twice a week and report on it in the next session.
Participants/Inclusion and exclusion criteria
- Having coronary heart disease based on diagnosis of a cardiologist in the hospital file - Having history of hospitalization - Severity of coronary heart disease should be considered according to moderate risk stratification. - All patients take medication. - Be one of the MI patients groups. - Do not be stable - Person's desire to enter research - Lack of chronic diseases and debilitating complications (such as thyroid, kidney, and liver diseases) - Physical ability of individuals to attend and follow the implementation process of the plan - Iranian nationality - Age 20 to 65 - Homogeneity in terms of socio-economics
Intervention groups
The Audio Psycho-education Package performed based on Bioenergy economy with Emphasis on forgiveness and the topics of Tensegrity relaxation, Body Awareness, Attention Work, Narrative Work , Relation Work, Intra-Intermediate Forgiveness, and Transpersonal Forgiveness. (Dr. Goli's protocol, 1398). Each podcast includes lessons, exercises, lesson summaries, and weekly assignments. There was no specific intervention for the control group, although both groups received routine cardiovascular drugs and routine care.
Main outcome variables
Life Quality, Vegetative function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200401046913N1
Registration date: 2020-04-09, 1399/01/21
Registration timing: retrospective

Last update: 2020-04-09, 1399/01/21
Update count: 0
Registration date
2020-04-09, 1399/01/21
Registrant information
Name
Jahanshir Tavakolizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 8529
Email address
drtavakolizadehj@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
2019-10-07, 1398/07/15
Actual recruitment end date
2019-11-06, 1398/08/15
Trial completion date
2020-03-17, 1398/12/27
Scientific title
The Effectiveness of a Psycho-education package based on Bioenergy economy with Emphasis on forgiveness on improvement of Quality of Life, and vegetative function of Patients with coronary Heart Disease
Public title
The Effectiveness of a Psycho-education package based on Bioenergy economy with Emphasis on forgiveness on improvement of Quality of Life, and vegetative function of Patients with coronary Heart Disease
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
- Having coronary heart disease based on the diagnosis of a cardiologist in the hospital file - Having a history of hospitalization - The severity of coronary heart disease should be considered according to moderate risk stratification. - All patients take medication - Be one of the MI patients. - Do not be stable - The person's desire to enter the research - Lack of chronic diseases and debilitating complications (such as thyroid, kidney, and liver diseases) - Physical ability of the person to attend and follow the process of project implementation (age is not too old) - Iranian nationality - Age 20- 65 year - Homogeneity in terms of socio-religious economics
Exclusion criteria:
- Absence of more than 3 sessions in training classes - Migration of the patient or death of the patient during the study - Withdrawal of the person to continue participating in the research
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: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
by simple random sampling
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 Isfahan University of Medical Sciences
Street address
School of Medicine,. Gonabad University of Medical Sciences., Dr Mahdizadeh Ave., Asian Road
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2019-12-11, 1398/09/20
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.467

Health conditions studied

1

Description of health condition studied
coronary Heart Disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery

Primary outcomes

1

Description
Life quality
Timepoint
Before intervention (pre-test), after intervention (post-test) and follow-up (after one month from the end of the intervention)
Method of measurement
THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE (WHOQOL) -BREF

2

Description
Vegetative Indicators
Timepoint
Before intervention (pre-test), after intervention (post-test) and follow-up (after one month from the end of the intervention)
Method of measurement
Standard monitoring device

Secondary outcomes

1

Description
Forgiveness
Timepoint
Before intervention (pre-test), after intervention (post-test) and follow-up (after one month from the end of the intervention)
Method of measurement
Forgiveness Questionnaire (Ray and et al)

Intervention groups

1

Description
Intervention group: A group that is under group training with an audio podcast for 8 sessions and routine cardiovascular care and medications.
Category
Treatment - Other

2

Description
Control group: that is only under routine cardiovascular care and medications
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Bohloul Hospital
Full name of responsible person
Shahrzad Mohseni
Street address
Bohlool Hospital., Vahdat Blvd ., Sadi Ave
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5723 6833
Email
dr.tavakolizadeh@gmu.ac.ir
Web page address
http://bohlool.gmu.ac.ir/Index.aspx?lang=1&sub=0

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Shahla Khosravan
Street address
Vice chancellor for research and technology., Gonabad University of Medical Sciences., dr Mahdizadeh Ave.,Asian road
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 9025
Fax
+98 51 5722 9025
Email
sdhprc@gmu.ac.ir
Web page address
http://res.gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Jahanshir Tavakolizadeh
Position
Full Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychology
Street address
Medicine School, Gonabad University of Medical Seinces., Dr Mahdizadeh Blvd., Asian Road.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 5027
Email
drtavakolizadehJ@yahoo.com
Web page address
http://isid.research.ac.ir/Jahanshir_Tavakolizadeh

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Jahanshir Tavakolizadeh
Position
Full Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychology
Street address
Medicine School, Gonabad University of Medical Seinces., Dr Mahdizadeh Blvd., Asian Road.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 5027
Email
drtavakolizadehJ@yahoo.com
Web page address
http://isid.research.ac.ir/Jahanshir_Tavakolizadeh

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Jahanshir Tavakolizadeh
Position
Full Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Medicine School, Gonabad University of Medical Seinces., Dr Mahdizadeh Blvd., Asian Road.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 5027
Email
drtavakolizadehJ@yahoo.com
Web page address
http://isid.research.ac.ir/Jahanshir_Tavakolizadeh

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 need to publish personal data at the article
Study Protocol
No - There is not 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
No - There is not 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
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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