Protocol summary

Study aim
Determining the effectiveness of using the R5 method for smoking cessation counseling at the pharmacy level
Design
Clinical trial with a control group, with parallel groups, randomized, without blinding, phase three on 220 patients, In order to create a randomization process, a simple randomization method is used using the card flipping method. In order to hide the randomization allocation, the sealed envelope method (SNOSE) was used. In this way, first the randomization sequence is created by the method of punching the cards, then based on the sample size, a number of envelopes and cards are placed inside the envelopes. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order.
Settings and conduct
A randomized clinical trial to investigate the effect of an educational pamphlet on smoking cessation based on the 5R method, which is carried out as an open-label in pharmacies affiliated with Tehran Islamic Azad University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1) Smoking 2) Age more than 18 years 3) both genders (male and female) 4) Be literate. 5) Have more than 2 years of usage history. Exclusion criteria: 1) Patient's lack of consent to participate in the study 2) consumption of other tobacco products (hookah, pipe, snuff, chewing tobacco, etc.)
Intervention groups
In the intervention group, an educational pamphlet developed to motivate smoking cessation using the R5 method is given to the smoker and he is requested to read and complete the pamphlet at home. In addition, he is asked to rate his willingness to quit smoking from zero (not at all) to very much (10). In the control group, no advice is given to quit smoking, and only a questionnaire of personal characteristics and scoring of the desire to quit is done.
Main outcome variables
Willingness to quit smoking (scoring scale 0 to 10)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220429054695N2
Registration date: 2024-03-11, 1402/12/21
Registration timing: prospective

Last update: 2024-03-11, 1402/12/21
Update count: 0
Registration date
2024-03-11, 1402/12/21
Registrant information
Name
Neda Koulaeinejad
Name of organization / entity
Faculty of Pharmacy, Tehran Medical Sciences, Islamic Azad University.
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 0056
Email address
nd.koulaei@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-01, 1403/01/13
Expected recruitment end date
2024-07-20, 1403/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of motivating individuals to quit smoking using the 5R method in a pharmacy: a randomized clinical trial
Public title
Quit smoking using the 5R method in a pharmacy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
مصرف سیگار سن بیشتر از 18 سال هر دو جنس (مرد و زن) سواد خواندن و نوشتن داشته باشند. بیش از 2 سال سابقه مصرف سیگار داشته باشد.
Exclusion criteria:
عدم رضایت بیمار جهت شرکت در مطالعه مصرف سایر فرآورده های تنباکو (قلیان، پیپ، انفیه، تنباکو جویدنی و ...) زنان باردار
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 220
Randomization (investigator's opinion)
Randomized
Randomization description
In order to create a randomization process, a simple randomization method is used using cards. In this method, a number of cards chosen by the researcher (2 numbers) are considered as the first group and the same number of cards for the next group; Then, by merging the cards together (merging the cards), one card is taken out and its assignment is recorded, and after that card is taken out, it is returned to the other cards. Then the cards are merged again and another card is removed. This process continues until reaching a random sequence according to the sample size. In order to hide the randomization allocation, the sealed envelope method (SNOSE) was used. In this way, first the randomization sequence is created by drawing cards, then based on the sample size, a number of envelopes with aluminum cover are prepared and each of the random sequences created on a registration card and the cards inside the envelopes Letters are placed in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. At the end, the lid of the letter envelopes is glued.
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 Islamic Azad University of Tehran Medical Sciences
Street address
No 99, Yakhchal street, Gholhak, Dr Shariati street
City
Tehran
Province
Tehran
Postal code
1941933111
Approval date
2023-11-29, 1402/09/08
Ethics committee reference number
IR.IAU.PS.REC.1402.493

Health conditions studied

1

Description of health condition studied
Nicotine dependence
ICD-10 code
F17.21
ICD-10 code description
Nicotine dependence, cigarettes

Primary outcomes

1

Description
Desire to quit smoking
Timepoint
After one week compared to the base score
Method of measurement
Rating scale zero to 10

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, an educational pamphlet developed to motivate smoking cessation using the 5R method is given to the smoker and he is requested to read and complete the pamphlet at home. In addition, he is asked to rate his desire to quit smoking from zero (not at all) to very much (10).
Category
Behavior

2

Description
Control group: In the control group, no advice is given to quit smoking, and only a questionnaire of personal characteristics and scoring of the desire to quit is done.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Pharmacies of Tehran Islamic Azad University of Medical Sciences
Full name of responsible person
Dr Neda Koulaeinejad
Street address
Faculty of Pharmacy, No 99, Yasman Alley, Yakhchal street, Gholhak, Dr. Shariati street
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0056
Email
nd.koulaei@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Neda Koulaeinejad
Street address
No 99, Yasman Alley, Yakhchal street, Gholhak, Dr. Shariati street
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0056
Email
nd.koulaei@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University
Proportion provided by this source
20
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Safari
Position
Pharm.D. candidate
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No 99, Yasman Alley, Yakhchal street, Gholhak, Dr. Shariati street
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0056
Email
f_safari1377@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Neda Koulaeinejad
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
No 99, Yasman Alley, Yakhchal street, Gholhak, Dr. Shariati street
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0056
Email
nd.koulaei@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Safari
Position
Pharm.D. candidate
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No 99, Yasman Alley, Yakhchal street, Gholhak, Dr. Shariati street
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0056
Email
f_safari1377@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All the data potentially can be shared after being unidentifiable.
When the data will become available and for how long
Just after the articles publication.
To whom data/document is available
For all investigators.
Under which criteria data/document could be used
Applicants should be researchers affiliated with universities of medical sciences and use the study data to conduct further research in the studied field.
From where data/document is obtainable
Applicants can contact the Department of Clinical Pharmacology, Pharmaceutical Sciences Unit, Islamic Azad University of Medical Sciences, Dr. Koulaeinejad, or the researcher's e-mail at f_safari1377@yahoo.com.
What processes are involved for a request to access data/document
Applicants can contact the Department of Clinical Pharmacology, Pharmaceutical Sciences Unit, Islamic Azad University of Medical Sciences, Dr. Koulaeinejad, or the researcher's e-mail at f_safari1377@yahoo.com.
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