Protocol summary

Summary
Effect of educational-counseling program based smoking cessation on success and self –efficacy of smoking cessation in acute coronary syndrome patients. Objective: Determination the effect of educational-counseling program based smoking cessation on success and self –efficacy of smoking cessation in acute coronary syndrome patients. Design: This is a pretest-posttest randomized one blind clinical trial study with two groups. The non-probabilistic sampling method and available for inpatients with diagnosis of acute coronary syndrome in Ghaem and Imam Reza hospitals, Mashhad. All of patients have the inclusion criteria. Patients allocated to intervention and control groups. This means that considered for every week of the first block (a block-week intervention and a control block week). First hospital and the intervention and control blocks has been selected with drawing. Sample size calculated 52 patients based on pilot study. Setting and conduct: In the intervention group, educational-consultation program and advice to quit smoking given in the control group .Inclusion criteria consist of definitive diagnosis of ACS (acute coronary syndrome) by a specialist, would like to participate in the study, have history of smoking at least six months before admission, having at least read and write ability,lack of mental disorders,lack of drug addictions,having conversations Call. Exclusion criteria consist of Unwillingness to continue to participate in educational- counseling sessions. Intervention: Two educational-counselling quit smoking sessions has been run each group (3 patients in group) for 45-60 minutes. Main outcome measures: Effect of educational-counseling program based smoking cessation on success and self – efficacy of smoking cessation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015033021566N1
Registration date: 2016-02-27, 1394/12/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-02-27, 1394/12/08
Registrant information
Name
Zeinab Kazemzadeh
Name of organization / entity
Mashhad Univrsity of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 915 525 7315
Email address
kazemzadehz921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research , Mashhad University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of educational-counseling program based smoking cessation on success and self – efficacy of smoking cessation in acute coronary syndrome patients
Public title
counseling of smoking cessation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. The definitive diagnosis of ACS (acute coronary syndrome) is by a specialist. 2. is willing to participate in the study. 3. have a history of smoking at least six months before admission. 4. have at least read and write. 5. be able to communicate and is fluent in Farsi. 6. mental disorder is not known because it requires the active cooperation of group counseling individuals. 7. Drug addiction is not. 8. make phone calls possible. Exclusion criteria: lack of desire to continue to cooperate and participate in training sessions - consulting group
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
cross way of doctors-Ebn Sina street-university of nursing and midwife
City
mashhad
Postal code
Approval date
2014-11-02, 1393/08/11
Ethics committee reference number
research/930440/1/213

Health conditions studied

1

Description of health condition studied
cardiac disease
ICD-10 code
I51.9
ICD-10 code description
I51.9

Primary outcomes

1

Description
success of smoking cessation
Timepoint
before intervention to 3 mounths after intervention
Method of measurement
success of smoking cessation questionnarie

2

Description
self-efficacy of smoking cessation
Timepoint
before intervention to 3 mounths after intervention
Method of measurement
smoking abstinence self-efficacy questionnarie(SASEQ)

Secondary outcomes

1

Description
Nicotine dependence
Timepoint
Every two weeks to 3 months2 weeks
Method of measurement
Fagereshtrum questioanarie

Intervention groups

1

Description
Intervention group: Intervention consist of 2 educational – counseling quit smoking sessions for 60-45 minute. First session: This session has been held at the heart department of both the hospital. The researchers introduced themselves to patients and the individual members introduced themselves. As well as the expectations of their meetings and the meetings of the researcher explained. The meeting is preparedness and intervention. The purpose of the meeting or the incentive to quit smoking. In this session researcher provides the necessary training about the dangers of smoking, the effects of smoking on the cardiovascular system, the importance of quitting smoking, the consequences and the effects of continued smoking. Researcher used video and slides, lecture, question and answer. Then, to start the procedure, researcher asked the question from members and asked them to think the problems encountered in quitting smoking. Researcher wrote Difficulties in quitting smoking expressed by members on the board and discussed about them. The task of the researcher, guide and encourage people to participate in the group and is accelerating. In addition, researchers using listening skills, empathy, understanding feelings, companionship, attention and other techniques aimed at establishing a therapeutic relationship with patients. At this meeting, the researcher tries to enable patients to know problems and share them with each other and their counterparts are the problems and experiences .After the meeting thinking about your problems and ask them at the next meeting. Second meeting: In this session researcher asked all members to identify problems related to smoking cessation based on their stated priorities. Based on the member’s consensus discussed about the most common problems. Researcher used of counseling techniques such as Socratic dialogue and insight at this stage and prior stage depending on the situation. At the end of the meeting, the overall conclusion of the solutions provided by the participants and to answer possible questions and ambiguities phone number will be placed at the disposal of clients. The maintenance phase is the phase of the three-month follow-up done. In the meantime, follow through 6 calls for up to 3 months in a row is done every two weeks. Phone calls made by a colleague. Self-efficacy and successfully questionnaire completed during a call. So the information gathered, classified and then will be compared and analyzed. Control group: In the control group were given routine care, including advice to quit smoking.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Mozhgan GHeyasi
Street address
Ebn-E-Sina street-Emam-Rza squer-Emam-Rza Hospital
City
Mashhad

2

Recruitment center
Name of recruitment center
Qaem hospital
Full name of responsible person
GHasem Rahmanian
Street address
SHariati square- Ahmad abad street-Qaem hospital
City
mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mohsen Tafaghodi
Street address
Daneshgah street- Building Qureshi-Vice Chancellor for research of Mashhad University of Medical Sciences
City
mashhad
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 of Mashhad 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
Mashhad University of Medical Science
Full name of responsible person
Zeinab Kazemzadeh
Position
Master of science of nursing education-medical-surgical
Other areas of specialty/work
Street address
Ebn-e-sina street-nursing and midewife university
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
kazemzadehz921@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Science
Full name of responsible person
Dr.Zahra Sadat Manzari
Position
Assistant Professor
Other areas of specialty/work
Street address
Ebn-e-sina street-nursing and midewife university
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
manzariz@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Science
Full name of responsible person
zeinab kazemzadeh
Position
Master of science of nursing education-medical-surgical
Other areas of specialty/work
Street address
Ebn-e-sina street-nursing and midewife university
City
Mashhad
Postal code
Phone
+98 518591511
Fax
Email
kazemzadehz921@mums.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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