Effect of Mindfulness-Based Intervention on Perceived Stress, Perception of Disease and Control Source in Patients with Acute Coronary Syndrome Admitted to Hospital
Determining the Effectiveness of Mindfulness-Based Intervention on Perceived Stress, Perception of Disease and Control Source in Patients with Acute Coronary Syndrome
Design
Controlled randomized clinical trail.
Blinding will not be done in this study.
Settings and conduct
Study setting will be Chamran Medical Center of Isfahan and sample size will be 76 subjects (38 in each group)
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients diagnosed with acute coronary syndrome by the cardiologist based on clinical and para-clinical diagnosis
Non-inclusion criteria: Having any diagnosed mental disorder; Co-morbid acute somatic disorders; Having any problems that interfere with communication and participation in the intervention
Intervention groups
Intervention group: Patients with acute coronary syndrome who will receive an intervention consisting of a 6-session program focusing on mindfulness techniques and their application to improve control over body and mental status.
Control group: Patients with acute coronary syndrome who are receiving routine care and do not participate in similar programs until the completion of the study.
Main outcome variables
Perceived stress; Perception of disease; Locus of control
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160927030002N2
Registration date:2019-04-30, 1398/02/10
Registration timing:prospective
Last update:2019-04-30, 1398/02/10
Update count:0
Registration date
2019-04-30, 1398/02/10
Registrant information
Name
Mousa Alavi
Name of organization / entity
Department of Psychiatric Nursing, Nursing and Midwifery Care
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7588
Email address
m_alavi@nm.mui.ac.ir
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2640-06-21, 2019/03/31
Expected recruitment end date
2640-11-21, 2019/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Mindfulness-Based Intervention on Perceived Stress, Perception of Disease and Control Source in Patients with Acute Coronary Syndrome Admitted to Hospital
Public title
Effectiveness of Mindfulness-Based Intervention on Mental Health in Patients with Acute Coronary Syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with acute coronary syndrome by the cardiologist based on clinical and paraclinical diagnosis.
The samples are willing to participate in the study
Subjects are aware of current conditions and type of illness
Research samples are from patients aged 35-70
Participants have full vigilance and awareness of time, place and person, and don't have any mental disabilities, significant cognitive or physical problems that prevent their participation in meetings.
Don't have any malignancy and mental disorders such as psychosis
Living in Isfahan
Research samples do not have a history of attending psychotherapy training sessions or similar studies over the past year.
Don't have any systemic diseases such as cancers and stroke.
Literacy to read and write
Have complete satisfaction to participate in the research project (identified by clinical interviewing and taking history).
Patients have full vigilance, acceptable hearing and speech ability.
Exclusion criteria:
Having any diagnosed mental disorder
Co-morbid acute somatic disorders
Having any problems that interfere with communication and participation in the intervention.
Age
From 35 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling is done in convenience form. Then, the names of the patients for whom a definite diagnosis of heart disease was given and those who have inclusion criteria are listed and then randomly assigned to two groups of intervention and control using SPSS software.
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
Isfahan University of Medical Sciences, Hezar Jarib street,
City
Isfahan
Province
Isfehan
Postal code
81745-319
Approval date
2019-03-18, 1397/12/27
Ethics committee reference number
IR.MUI.RESEARCH.REC.1397.491
Health conditions studied
1
Description of health condition studied
Perceived stress
ICD-10 code
F43.0
ICD-10 code description
Acute stress reaction
2
Description of health condition studied
Perception of Disease
ICD-10 code
R44.9
ICD-10 code description
Unspecified symptoms and signs involving general sensations and perceptions
Primary outcomes
1
Description
Perceived Stress
Timepoint
Three steps before, immediately and one month after the intervention
Method of measurement
Perceived Stress Scale
2
Description
Perception of Disease
Timepoint
Three steps before, immediately and one month after the intervention
Method of measurement
Illness Perception Questionnaire
3
Description
Locus of Control
Timepoint
Three steps before, immediately and one month after the intervention
Method of measurement
Rotter's Locus of Control Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Six sessions of Mindfulness-based treatment plan will be implemented according to the Kabat-Zinn Protocol (Kabat-Zinn, Massion et al., 1992). 45-minute sessions once a week (for 6 sessions), in the morning shift, and from 9:00 to 10:00 AM, will be held.
Category
Rehabilitation
2
Description
Control group: Includes a group of patients similar to those in the intervention group who receive routine care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran Hospital
Full name of responsible person
Gholamreza Masomi
Street address
Moshtagh Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3260 0961
Email
akbari129@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Tahereh Changiz
Street address
Hezarjarib Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 1668 7153
Email
webmaster@nm.mui.ac.ir
Grant name
Thesis
Grant code / Reference number
IR.MUI.RESEARCH.1397.491
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mousa Alavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hezarjarib Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 1668 7153
Email
m_alavi@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfarayen University of Medical Sciences
Full name of responsible person
Mousa Alavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hezarjarib Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 1668 7153
Email
m_alavi@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfarayen University of Medical Sciences
Full name of responsible person
Mousa Alavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hezarjarib Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 1668 7153
Email
m_alavi@nm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is shared upon request.
When the data will become available and for how long
Sharing time will be started 6 months after publication of paper
To whom data/document is available
For researchers and institutions upon request
Under which criteria data/document could be used
Use of data for research purposes is allowed.
From where data/document is obtainable
Asked by e-mail at the following address
m_alavi@nm.mui.ac.ir
What processes are involved for a request to access data/document
The applicant must submit a Letter of Approval for the research project.