The Comparison of the effectiveness of emotional self-regulation strategies with coping strategies on emotional regulation and health development in the use of coronary heart disease
The aim of this study was to compare the effectiveness of emotional self-regulation strategies with pain coping strategies on emotional process regulation and health dimensions in coronary heart patients.
Design
A randomized clinical trial with parallel groups
Settings and conduct
The location of this study was Heshmatieh Hospital in Sabzevar. After coordination with hospital officials regarding the implementation of the study, the list of patients with coronary artery disease was received. Then, 67 patients were selected from the inclusion criteria and then 45 of them were randomly selected (lottery-type) and randomly assigned to three groups of emotional self-regulation strategies training, pain coping strategies training, and control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Diagnosis of coronary heart disease
2. Ability to listen
3- Do not suffer from acute immunodeficiency and psychiatric disorders
4- Personal and conscious satisfaction
Exclusion Criteria:
1- Disrupting the order of the meeting
2. Two consecutive absences
3- Receiving any other psychotherapy intervention
4- Failure to do assignments
Intervention groups
For the first group, emotional self-regulation strategies training will be done for the second group to teach pain coping strategies. The third group will be the control group that will not receive any intervention.
Main outcome variables
Emotional process regulation and health dimensions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210529051425N1
Registration date:2021-07-10, 1400/04/19
Registration timing:registered_while_recruiting
Last update:2021-07-10, 1400/04/19
Update count:0
Registration date
2021-07-10, 1400/04/19
Registrant information
Name
ehsan ebrahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4465 1300
Email address
e.ebrahimi@iaukishint.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-01, 1400/03/11
Expected recruitment end date
2021-09-02, 1400/06/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of the effectiveness of emotional self-regulation strategies with coping strategies on emotional regulation and health development in the use of coronary heart disease
Public title
Effectiveness of emotional self-regulation strategies and pain coping strategies in coronary heart patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of coronary heart disease
Ability to listen
No acute immune disease and psychiatric disorders
Personal and informed consent
Exclusion criteria:
Receiving any other psychotherapy intervention
Use of antidepressants and anti-stress medications
Age
From 25 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization unit: individual
Randomization type: Block randomization, blocks with size of 6
Randomization tool: Random number table
Random Chain Concealment Method: Use a matte envelope
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
Hormozgan University of Medical Sciences
Street address
No.51, Ibn Yamin, Ibn Yamin Street
City
Sabzvar
Province
Hormozgan
Postal code
96465223
Approval date
2020-05-17, 1399/02/28
Ethics committee reference number
IR.HUMS.REC.1399.082
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
Emotional process regulation
Timepoint
Measurement will be done in the pre-test, post-test, and follow-up three months after post-test
Method of measurement
Emotion Regulation Questionnaire (ERS) Gross and John (2003)
2
Description
Mental health
Timepoint
Measurement will be done in the pre-test, post-test, and follow-up three months after post-test
Method of measurement
Goldberg General Health Questionnaire (GHQ-28) (1979)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group 1: Emotional self-regulation strategies training is a skill developed by Gross Educational Pack (2004) in a specialized and workshop (including emotional training, evaluation of emotional vulnerability and emotional skills of members, training attention change skills, changing behavioral and physiological consequences of emotion, and reassessment and planning for the application of training) in 8 sessions (two sessions per week and each session for 90 minutes) Training was given to the members of the group.
Category
Other
2
Description
Intervention group 2: Teaching pain coping strategies are skills developed by Smith et al. (2012) in a specialized and workshop training package (including providing attention-grabbing strategy for pain and its types, teaching positive self-talk, teaching ignoring pain strategy, Training in disaster strategy, and spirituality, and training to increase behavioral activity) were taught in 8 sessions (two sessions per week and each session for 90 minutes) for one month.
Category
Other
3
Description
Control group: The control group received no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Sabzevar Heshmatieh Hospital
Full name of responsible person
Mohammad Hatami
Street address
No.51, Ibn Yamin, Ibn Yamin Street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9645265
Phone
+98 51 4423 4756
Email
EHSAN.EBRAHIMI58@GMAIL.COM
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Hatami
Street address
No.51, Ibn Yamin, Ibn Yamin Street
City
Sabzevar
Province
Razavi Khorasan
Postal code
96542236
Phone
+98 51 4423 4756
Email
EHSAN.EBRAHIMI58@GMAIL.COM
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Ehsan Ebrahimi
Position
Ph.D. student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.51, Ibn Yamin, Ibn Yamin Street
City
Sabzevar
Province
Razavi Khorasan
Postal code
96542263
Phone
+98 51 4423 4756
Email
EHSAN.EBRAHIMI58@GMAIL.COM
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ehsan Ebrahimi
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Ibn Yamin St. - Ibn Yamin 51
City
Sabzevar
Province
Razavi Khorasan
Postal code
96542263
Phone
+98 51 4465 1300
Fax
Email
e.ebrahimi@iaukishint.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ehsan Ebrahimi
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Ibn Yamin St. - Ibn Yamin 51
City
Sabzevar
Province
Razavi Khorasan
Postal code
96542263
Phone
+98 51 4465 1300
Fax
Email
e.ebrahimi@iaukishint.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
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
Title and more details about the data/document
Only part of the data, such as information about the main outcome or the like, can be shared.
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Any type of analysis on the data delivered is permitted
From where data/document is obtainable
Ehsan Ebrahimi
What processes are involved for a request to access data/document
The request will be sent by email to: e.ebrahimi@iaukishint.ac.ir