The purpose of the study was to determine the effect of motivational interview on self-efficacy, craving and addiction to hookah in pregnant women referring to health care centers in Zahedan city in 1396.
Design
At first, among pregnant women who use the hookah in the health centers of the city of Zahedan, who are pregnant and who are referred to these centers for prenatal care, 140 people are eligible for inclusion criteria, then with The random allocation is divided into two groups: intervention and control.
Settings and conduct
The place of study is the health centers of Zahedan suburbs. How to conduct a motivational interviewing group counseling session during four 45-90 minute sessions of two sessions.
Participants/Inclusion and exclusion criteria
Criteria for entering the study: 1- At least 6 times a month for hookahs. 2. No psychiatric disorder.
Exit criteria: 1. Failure to attend or absent more than one session in the motivational counseling program. 2. Pregnancy problems during the course of the implementation. Intervention (abortion, and .....)
Intervention groups
The intervention group will provide motivational interviewing group counseling sessions in four sessions of 45 to 90 minutes a week, two sessions at the clinic and at agreed time with women in groups of 4 to 9 people. The control group will only receive routine pregnancy training and advice and training on the harm and consumption of hookah.
Main outcome variables
Self-efficacy of reducing hookah consumption; Reducing dependence on hookahs; Reducing hookah craving.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160924029954N5
Registration date:2018-01-22, 1396/11/02
Registration timing:retrospective
Last update:2018-01-22, 1396/11/02
Update count:0
Registration date
2018-01-22, 1396/11/02
Registrant information
Name
Ali navidian
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 2482
Email address
alinavidian@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
goverment
Expected recruitment start date
2017-06-20, 1396/03/30
Expected recruitment end date
2017-11-21, 1396/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of motivational interviewing on self-efficacy, craving and hookah dependency in pregnant women.
Public title
Impact of Motivational Interview on reducing hookah consumption
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
gestational age less than 22 weeks
have been used regularly for at least 6 months.
The lack of psychiatric disorders
Non-addiction to any substance other than the smoking hookah
is not subject to a specific training program.
Exclusion criteria:
Failure to attend or absent more than one session in the Motivational Counseling Program
pregnancy complications during the intervention (abortion, etc.)
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment to intervention and control groups. Participants in the study are randomly assigned to two groups of intervention and control. First, the envelope containing the study groups will be sorted out and randomly ordered. Gradually, by identifying the eligible person, one of the envelopes will be allocated to the selected individuals, respectively.
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 Zahedan University of Medical Sciences
Street address
Dr hesabi's Square،Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167-43463
Approval date
2017-06-12, 1396/03/22
Ethics committee reference number
IR.ZAUMS.REC.1396. 57
Health conditions studied
1
Description of health condition studied
Tobaco
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Self-efficacy of reducing hookah consumption in pregnant women
Timepoint
Before the intervention and eight weeks after the intervention
Method of measurement
Self-efficacy inventory of hookah consumption
2
Description
Dependence on hookah in pregnant women
Timepoint
Before the intervention and eight weeks after the intervention
Method of measurement
Dependence on hookah consumption questionnaire
3
Description
Hookah craving for pregnant women
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Indicator of Craving
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group : For the intervention group, motivational interviewing group counseling sessions will be conducted in five sessions of 45 to 90 minutes a week, at the clinic and at agreed time with women in groups of 4 to 9 people.
Category
Behavior
2
Description
Control group: The control group will only receive routine pregnancy training and advice and training on the hookah's health.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid barazande Health Center
Full name of responsible person
Zahra jodaei
Street address
Murad Qolli 30، Shahid barazande Health Center
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9814675465
Phone
+98 54 3331 9553
Fax
+98 54 3331 9553
Email
zahrajodaei@gmail.com
Web page address
http://zaums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Noor Mohammad Bakhshani
Street address
Dr Hesabi Square, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 1341 6708
Fax
+98 54 1341 6708
Email
public@zaums.ac.ir
Web page address
http://zaums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Kheirolnesa Mojahed
Position
Midwifery Bachelor
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Dr hesabi Square, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2482
Fax
+98 54 3344 2481
Email
nesamojahed@gmail.com
Web page address
http://zaums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Ali Navidian
Position
P.H.D
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Dr Hesabi Square, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2482
Fax
+98 54 3344 2481
Email
alinavidian@gmail.com
Web page address
http://zaums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Kheirolnesa Mojahed
Position
Midwifery Bachelor
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Dr Hesabi Square, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2482
Fax
+98 54 3344 2481
Email
nesamojahed@gmail.com
Web page address
http://zaums.ac.ir/
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
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Information about study implications
When the data will become available and for how long
Starting the access period from 2018
To whom data/document is available
academic researchers
Under which criteria data/document could be used
There are no special conditions
From where data/document is obtainable
by emil: nesamojahed@gmail.com
What processes are involved for a request to access data/document