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Comparison of Nicotine Replacement Therapy (NRT) and Nursing consulting on smoking cessation and Spiro metric indexes of smokers candidate for Coronary Artery Bypass Graft (CABG)

Protocol summary

Summary
Objective: Comparison of Nicotine Replacement Therapy (NRT) and Nursing consulting on smoking cessation and Spiro metric indexes of smokers candidate for Coronary Artery Bypass Graft (CABG) , Study design: Randomized controlled trial, with two intervention groups Sample size: 60 participants, Inclusion Criteria: candidate for CABG, smoker and be able to cooperation with research project, Exclusion Criteria: Unstable medical status and refuse for cooperating in study Interventions: After obtaining informed consent from patients in physician clinic, interviewing and filling out the study questionnaire, Fagersturm questionnaire and offering smoking cessation education pamphlet, patients will be divided to both intervention groups (by blocked randomization). Treatment groups include, Nursing consulting group, which will provide consulting for help participants to quit smoking during study time table by telephone contacts. (3 weeks before till 3 weeks after surgery) The other intervention group consist Nicotine Replacement Therapy (NRT). Participants in this group will be allowed to use nicotine gums in requirement times. Instructions of using NRT gums will be teached them in the first time and also by phone contact. Moreover, they will receive nicotine patches by researcher once a day at the time of hospitalization. Patients' pulmonary indexes will be examined by spirometry devices in two times. (A day before surgery and two weeks after that) during the study, another person instead of researcher will follow level of adherence to cessation by telephone contacts and visits during hospitalization. Researcher will visit patients, teach, guide and consult them during hospitalization. Data will be analyzed by SPSS 16 statistics software, descriptive and analytic tests.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014071518499N1
Registration date: 2014-10-06, 1393/07/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-10-06, 1393/07/14
Registrant information
Name
Fatemeh Bakhshi
Name of organization / entity
Nursing and midwifery faculty, Tehran university of medical sciences-
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
f_bakhshi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of medical sciences, School of Nursing and Midwifery
Expected recruitment start date
2014-08-06, 1393/05/15
Expected recruitment end date
2015-01-20, 1393/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Nicotine Replacement Therapy (NRT) and Nursing consulting on smoking cessation and Spiro metric indexes of smokers candidate for Coronary Artery Bypass Graft (CABG)
Public title
Effect of Nicotine and Consulting on smoking cessation and pulmonary indexes in patients candidate for heart surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: 1. Age 18 years or more 2. Patients tend to have quit smoking 3. Candidates of CABG surgery 4. Non-emergency CABG surgery 5. Smoking addiction 6. No history of mental disorder or having psychologically Cooperation 7. Not allergic to nicotine patches and gum 8. Ability to properly use of nicotine patches 9. Non-use of other cessation forms 10. Have no Addiction to alcohol and other drugs 11. Not having acute or severe respiratory disorders Exclusion Criteria: 1. Occurrence of unstable medical conditions and inability to continue cooperation in the study. 2. Refuse cooperation in study or continue smoking during the study period 3. Conflict to other postoperative complications in such a way that makes it impossible to continue study participation
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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 Tehran University of Medical Sciences.
Street address
Sixth floor, in the corner of Ghods St., Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2014-05-25, 1393/03/04
Ethics committee reference number
130/486/د/93

Health conditions studied

1

Description of health condition studied
Smokers Candidate for Coronary artery Bypass Graft surgery (CABG)
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease

Primary outcomes

1

Description
Smoking Cessations
Timepoint
Measurements time intervals: Smoking cessation: It will be monitored according to time table. In the way that, during 3 weeks before and till 3 weeks after surgery which is research time table, we will contact to patients and their families separately 2-3 times a week for examining adherence to cessations.
Method of measurement
For smoking cessation: telephone contacts to patients and their families according to time table

2

Description
Patients' Spirometric Indexes
Timepoint
Spirometric indexes: examinations of patients' pulmonary indexes and function by computerized spirometry test in two times (one day before surgery and 2 weeks after that)
Method of measurement
For spirometric indexes: by spirometry Device

Secondary outcomes

1

Description
demographic data and medical history
Timepoint
at the beginning of study in physician clinic
Method of measurement
by interviewing and questionnaire

Intervention groups

1

Description
In NRT group, at the beginning of participation, researcher will explain instructions and dosage of using nicotine gums for patients and their family. Then we will give patients two boxes of gums till the time of surgery, which contain 30 gums in each box and each gum, provide 2mg nicotine. During hospitalization days which are near one week, we will use nicotine patches. Each patch is for daily use and contains 17.5 mg nicotine. After that on the time of discharge, two other boxes of gums will be given to them for their demands on non-hospitalization days. This dosage has approved by experts of cessation center and physicians. (Since hospitalization and postoperative conditions may cause some limitations for using nicotine gums, it's better to use patches instead, in these days which are better for observing amount of NRT that has been used). We will give participants a phone number for contact to researcher and report their allergic reactions, and other problems which make them unable to cooperate with study and also for extra questions.
Category
Treatment - Drugs

2

Description
In consulting group, intervention will be accomplished by phone-consulting (in 10-15 minutes duration each time) and 3 times a week, in non-hospitalization days. (For hospitalization days consults will do in presence). Consults will be done in organized and scheduled method. At the beginning, researcher will examine patients and their family needs for consulting. After that, in each telephone contacts according to their needs, researcher will explain for them, smoking risk factors, cessation benefits, cessation withdrawal symptoms and ways to encounter with them. Researcher also will assess participants' trends for quit smoking, stresses and problems that they encounter with about quitting, then will try to persuade them for cessation and try to remain on it. Also we will give a phone number to participants for contact researcher if necessary.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd Herat Center Hospital
Full name of responsible person
Fateme Bakhshi,MSc student in Medical-Surgical Nursing The Tehran University,Iran
Street address
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical sciences Vice chancellor for research
Full name of responsible person
Dr. Masood Yunesian
Street address
Tehran University of Medical Sciences, Sixth floor, in the corner of Ghods St., Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical sciences Vice chancellor for research
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
Tehran University of medical Sciences- School of Nursing and Midwifery
Full name of responsible person
Fateme Bakhshi
Position
Master of Nursing Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Dr. Mirkhani St., (East Nosrat) , Tohid Sq.
City
Tehran
Postal code
1419733171
Phone
+98 35 1620 4053
Fax
+98 21 6690 4252
Email
f_bakhshi@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of medical Sciences- School of Nursing and Midwifery
Full name of responsible person
Dr. Shokooh Varaei
Position
PHD of Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Dr. Mirkhani St., (East Nosrat) , Tohid Sq.
City
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
+98 21 6690 4252
Email
shvaraei@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences- School of Nursing and Midwifery
Full name of responsible person
Fatemeh Bakhshi
Position
Master of Nursing Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Dr. Mirkhani St., (East Nosrat) , Tohid Sq.
City
Tehran
Postal code
Phone
+98 35 1629 4953
Fax
Email
f_bakhshi@razi.tums.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
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