Protocol summary

Summary
The present study is a clinical trial with a randomized design of the experimental and control group with pretest-post-test-follow-up. A simple randomization with lottery will be done with 0 and 1 numbers and blindness will not be done. 84 patients hospitalized in the cardiac intensive care unit of hospitals affiliated to Shahrekord University of Medical Sciences are selected based on inclusion criteria and are divided into two groups of 42 people. In the absence of patient cooperation, the patient's death during the study and complications of life threatening complications will be excluded. First, the questionnaire for demographic information and disease information, Hospital Anxiety And Depression Scale, Life Orientation Test-Reviseved, Positive and Negative Affect Scale (PANAS)and Hope Questionary will be completed. Voice messages will be distributed to the patients in the intervention group, with emphasis on the optimism structure and optimistic mental exercises along with messages containing heart self-care information through headphones. For the control group only messages containing your cardiac care information are broadcast.Three days at the time of admission, and messages will be broadcast four times a day, up to six weeks after discharge, and two times a week. After discharge from the hospital one week after the intervention and six weeks after the completion of the intervention, the questionnaires are completed again. Tracking will be done through checklist and phone call. The main outcome variables are optimism, positive affection, hope, anxiety and depression.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017092532764N4
Registration date: 2017-11-05, 1396/08/14
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-11-05, 1396/08/14
Registrant information
Name
Shahla Abolhassani
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 3333 5648
Email address
abolhasani@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahrekord University of Medical Sciences
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of positive psychology-based audio messages on psychological variables in patients with acute coronary syndrome
Public title
The effect of positive psychology-based audio messages on patients with acute coronary syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: confirmation of Acute Coronary Syndrome by Cardiologist; no history of hospitalization in the cardiac care unit; willingness to participate in the study; ability to understand conversation in Persian language; age of 30 to 75 years; no use of psychological treatment; having no hearing problems Exclusion criteria: failure to co-operate with the patient; patient's death during the study; complications of life threatening complications
Age
From 30 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
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 Shahrekord University of Medical Sciences and Health Service
Street address
Shahrekord University of Medical Sciences and Health Service , Kashani street, Shahrekord
City
Shahrekord
Postal code
Approval date
2017-09-13, 1396/06/22
Ethics committee reference number
IR.SKUMS.Rec.145

Health conditions studied

1

Description of health condition studied
acute coronary syndrome
ICD-10 code
120
ICD-10 code description
Angina pectoris

2

Description of health condition studied
acute coronary syndrome
ICD-10 code
121
ICD-10 code description
acute myocardial infarction

3

Description of health condition studied
acute coronary syndrome
ICD-10 code
122
ICD-10 code description
Subsequent myocardial infarction

4

Description of health condition studied
acute coronary syndrome
ICD-10 code
123
ICD-10 code description
Certain current complications following acute myocardial infarction

5

Description of health condition studied
acute coronary syndrome
ICD-10 code
124
ICD-10 code description
Other acute ischaemic heart diseases

Primary outcomes

1

Description
anxiety
Timepoint
before the intervention, after discharge from the hospital, one week after the intervention and six weeks after the intervention.
Method of measurement
Hospital Anxiety And Depression Scale

2

Description
depression
Timepoint
before the intervention, after discharge from the hospital, one week after the intervention and six weeks after the intervention.
Method of measurement
Hospital Anxiety And Depression Scale

3

Description
hope
Timepoint
before the intervention, after discharge from the hospital, one week after the intervention and six weeks after the intervention.
Method of measurement
Hope Questionary

4

Description
optimism
Timepoint
before the intervention, after discharge from the hospital, one week after the intervention and six weeks after the intervention.
Method of measurement
Life Orientation Test-Reviseved

5

Description
positive affect
Timepoint
before the intervention, after discharge from the hospital, one week after the intervention and six weeks after the intervention.
Method of measurement
Positive and Negative Affect Scale (PANAS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: they will receive audio file of positive psychological messages with topics of morning optimism, short term and temporal hospitalization, positive perception of CCU hospitalization event, external and non-permanent view of hospitalization process, hope for alleviation and its effect, positive imaging of the future in the field of heart health, meditation focused on positive imaging of the heart and blood vessels, optimistic appreciation of the severity of symptoms of my heart disease, controllability of my heart disease, optimistic appreciation during sleep, and cardiac self-care through the headphones four times a day for three-day hospitalization. And for six weeks at home, they will receive twice a week the optimistic psychological messages with topics of positive interpretation of the damage and heart disease, post-traumatic development, optimistic appreciation of the symptom severity of my heart disease, hope for the future, controllability of my heart disease, readiness to cope with the crisis -for the worst possible condition, positive mindfulness and self-talk, optimism for social support, short-term and temporal acute period of illness, morning optimism when awakening, good appreciation at bedtime, transform optimism into a habit and cardiac self-care through headphone.
Category
Other

2

Description
Control group: They will receive audio file of self-care messages with the topics related to getting acquainted with the cardiac care unit, the cardiovascular system, the risk factors of coronary artery disease, angina pectoris, heart attack, and hospital treatments through headphones two times a day for three-day hospitalization. Then for six weeks at home, they will receive messages with the topics related to the examination and control of disease symptoms, the adoption of a treatment regimen, the maintenance of healthy lifestyle, controlling the impact of the disease on the daily performance by voice and with Headphones twice a week.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hajar hospital
Full name of responsible person
Sara Hadadzadeh
Street address
Hajar hospital, Parastar street, Shahrekord
City
Shahrekord

2

Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Sara Hadadzadeh
Street address
Kashani hospital, Parastar street, Shahrekord
City
Shahrekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shahrekord University of Medical Sciences and Health Service
Full name of responsible person
Kamal Solati
Street address
Shahrekord University of Medical Sciences and Health Service , Kashani street, Shahrekord
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahrekord University of Medical Sciences and Health Service
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahrekord University of Medical Sciences and Health Service
Full name of responsible person
Sara Hadadzadeh
Position
MSc. Nursing
Other areas of specialty/work
Street address
Shahrekord University of a Medical Sciences and Health Service , Kashani street, Shahrekord
City
Shahrekord
Postal code
Phone
+98 381330061
Fax
Email
sarahadad1363@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrekord University of Medical Sciences and Health Service
Full name of responsible person
Shahla Abolhassani
Position
PHD. Nursing
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences and Health Service , Kashani street, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3333 0061
Fax
Email
Sh_abolhassani@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahrekord University of Medical Sciences and Health Service
Full name of responsible person
Sara Hadadzadeh
Position
MSc. Nursing
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences and Health Service , Kashani street, Shahrekord
City
Shahrekord
Postal code
Phone
+98 381330061
Fax
Email
sarahadad1363@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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