Protocol summary

Summary
The effect of cardiac rehabilitation on depression and anxiety in patients after stent implantation. Study design: 100 patients ;Study population: patients after stenting before and after the rehabilitation program. Main Inclusion criteria: Diagnosis is confirmed by medical experts and the results of diagnostic test; Have the ability to understand conversations in Persian; Have at least read and writer; the ability to complete questionnaires and interviews patients age range between 30 and 70 years. Exclusion criteria: A history of depression, a history of anxiety, heart failure, need for surgery under cardio pulmonary bypass, CABG, no consent for or continue the study, intervention of study: cardiac rehabilitation will be done in partnership with families. The primary outcome or consequences of the study: Hamilton depression and anxiety questionnaire before and after cardiac rehabilitation after stenting

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016030226868N1
Registration date: 2016-10-28, 1395/08/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-10-28, 1395/08/07
Registrant information
Name
Zhila Khamnian
Name of organization / entity
Community Medicine Department, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 4668
Email address
khamnianj@tbzmed.ac.it
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Depression and Anxiety in Coronary Heart Diseases Patients
Public title
The effect of cardiac rehabilitation on depression and anxiety in patients after stent implantation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis is confirmed by medical experts and the results of diagnostic test; Have the ability to understand conversations in Persian; Have at least read and writer; the ability to complete questionnaires and interviews patients age range between 30 and 70 years. Exclusion criteria: no visit to the rehabilitation center for any reason, A history of depression, a history of anxiety, heart failure, need for surgery under cardio pulmonary bypass, CABG, no consent for or continue the study
Age
From 29 years old to 69 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committe of Tabriz University of Medical Science
Street address
Tabriz University of Medical Science, Golgasht Aveniue,Tabriz, East Azarbaijan
City
Tabriz
Postal code
Approval date
2016-01-04, 1394/10/14
Ethics committee reference number
TBZMED.REC.1394.907

Health conditions studied

1

Description of health condition studied
Coronary Artery Disease(Depression and Anxiety)
ICD-10 code
I24.9
ICD-10 code description
Acute ischaemic heart disease, unspecified

Primary outcomes

1

Description
Anxiety
Timepoint
before intervention - 4 months after intervention
Method of measurement
Hmilton Anxity questionare

2

Description
Depression
Timepoint
before intervention - 4 months after intervention
Method of measurement
Hamilton Depression Questionare

Secondary outcomes

empty

Intervention groups

1

Description
cardiac rehabilitation including self-care training, nutritional advice, stress reduction and exercise were presented in Madani hospital and Sheikholraees outpatient clinics, at four 20 minute training session
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Sheikhol Raees Cardiac clinic
Full name of responsible person
Maryam Shahamfar
Street address
Sheikhol Raees Cardiac clinic, Azadi Ave, Tabriz, Iran
City
Tabriz

2

Recruitment center
Name of recruitment center
Shahid Madani Clinic
Full name of responsible person
Street address
Shahid Madani Clinic, Golgasht St, Azadi Ave, Tabriz, Iran
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Science
Full name of responsible person
Mojgan Mirgaffarvand
Street address
Golgasht Ave.Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Science
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
Community Medicine Department , Tabriz University of Medical Science
Full name of responsible person
Dr Zhila Khamnian
Position
Community Medicine Assistant Professor
Other areas of specialty/work
Street address
Tabriz University of Medical Science, Golgasht Ave, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 3336 4668
Fax
Email
zhila.khamnian@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Community Medicine Department , Tabriz University of Medical Science
Full name of responsible person
Dr zhila Khamnian
Position
Community Medicine Specialist/Assistant Professor
Other areas of specialty/work
Street address
Faculty of Medicine , Tabriz University of Medical Science, Golgasht Ave, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 413364668
Fax
Email
zhila.khamnian@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Science
Full name of responsible person
Zhila Khamnian
Position
Assistant Professor
Other areas of specialty/work
Street address
Tabriz University of Medical Science, Golgasht Ave, Tabriz, Iran
City
Tabriz
Postal code
Phone
00
Fax
Email
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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