Protocol summary

Summary
Aim of study is determine the effect of psychological education on mental health and quality of life in patients with coronary heart disease. This is a clinical trial study. Sample size is 70 patients with coronary heart disease that selected by sequence Sampling. In according to researchers selected eligible hospitalized patients with coronary artery disease who are admitted to the Emergency and CCU wards. Inclusion criteria of study are patients with: 1- Aged 21 to 65 years old; 2- Able to respond to inquiries and attending meetings; 3- No history of angioplasty and CABG (Coronary Artery Bypass Graft Surgery); 4- Any known problems including Alzheimer's brain, a stroke-transient cerebral attack. Exclusion criteria of study are patients with: 1- Acute and emergency medical and psychological conditions; 2- Unwillingness to continue participation in the intervention; 3- Migration of the patients. After explaining the objectives of study and informed consent data were collected using demographic information, Goldberg mental health (28 questions) and Mac New quality of life questionnaire. Then eligible patients randomized to intervention and control groups. For intervention group will be applied Psycho-educational intervention in 8 sessions, twice a week, ach section lasts 45 to 60 minutes. Control group will be received routing cares without psychological interventions. Sessions topics of Psycho-educational intervention were include: “How to coping anxiety with an emphasis on life skills, teaching of anger management, problem solving and communication skills, coping skills to depression and relaxation training”. Outcomes: management of anger, anxiety, depression and establish proper communication behaviors in patients with coronary heart disease. After of intervention and one month groups will fill out questionnaires again.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014060114086N4
Registration date: 2014-07-18, 1393/04/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-07-18, 1393/04/27
Registrant information
Name
Mohammad Aghajani
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 2001
Email address
aghajani_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-07-23, 1393/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Psychoeducational on mental health and quality of life in patients with coronary heart disease
Public title
Effect of Psychoeducational in patients with coronary heart disease
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1 - age between 21-65 years old. 2 - Patient is able to respond to inquiries and attending meetings. 3- No history of angioplasty and CABG (Coronary artery bypass graft). 4 - Having brain problems identified include Alzheimer's disease, stroke, and transient ischemic attack. 5 - Have writing and reading ability. Exclusion criteria: 1 - The existence of critical and emergency medical and psychological conditions. 2 - No desire to continue to participate in the intervention. 3 - Died or migrated patients.
Age
From 21 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
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
Kashan University of medical Science
Street address
Ghotbe Ravadi, Kashan
City
Kashan
Postal code
Approval date
2014-05-06, 1393/02/16
Ethics committee reference number
9327

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
F53.0
ICD-10 code description
Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified

2

Description of health condition studied
Anexiety
ICD-10 code
F40
ICD-10 code description
Phobic anxiety disorders

Primary outcomes

1

Description
Depression
Timepoint
One month later
Method of measurement
Health Questionnaire

2

Description
Anxiety
Timepoint
One month later
Method of measurement
Health Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Control group: routine care of patients with coronary artery disease who are receiving.
Category
N/A

2

Description
Intervention group: psycho-educational intervention in a group of 8 sessions, 45 to 60 minutes, 2 times a week for two days of fall. Training sessions with at least 7 to 8 persons also are formed with repeated training sessions in the days and hours of participation in all patients at the meetings is provided. Sessions include training on psychological problems such skills to deal with anxiety, with an emphasis on lifestyle skills anger management training, problem solving skills, coping skills, depression, relaxation training are
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Martyr Beheshti Hospital
Full name of responsible person
Bashiri Zahra
Street address
School of Nursing and Midwifery, Km 3 pole Ravandi,Kashan
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholam Ali Hamidi
Street address
Ghotbe Ravandi, Kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
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
Kashan University of Medical Sciences
Full name of responsible person
Muhammad Aqhajani
Position
Masters
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Km 3 pole Ravandi,Kashan
City
Kashan
Postal code
8715988141
Phone
+98 36 1555 0021
Fax
+98 36 1555 3366
Email
aghajani1362@yahoo.com; aghajani_m@kaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Muhammad Aqhajani
Position
Master
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Km 3 pole Ravandi,Kashan
City
Kashan
Postal code
8715988141
Phone
+98 36 1555 0021
Fax
+98 36 1555 3366
Email
aghajani1362@yahoo.com; aghajani_m@kaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Muhammad Aqhajani
Position
Masters
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Km 3 pole Ravandi,Kashan
City
Kashan
Postal code
8715988141
Phone
+98 36 1555 0021
Fax
+98 36 1555 3366
Email
aghajani_m@kaums.ac.ir
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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