Protocol summary

Study aim
The impact of motivational counseling on increasing couples interest for premarital genetic tests during marriage in referents to counseling center in Arak in 1396 year
Design
The present study is a clinical and double blind clinical trial that is carried out on 280 couples aged 20 to 35 years old referred to marriage counseling center in Arak. Out of 280, 40 couples are selected and randomly divided into two groups.
Settings and conduct
The present study is a clinical and double blind clinical trial that is carried out on 280 couples aged 20 to 35 years old referred to marriage counseling center in Arak. Out of 280, 40 couples are selected and randomly divided into two groups.This study is double blind.Outcome elevator and analyzer are blind (double blind).Outcome elevator and analyzer don't aware from grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Couples married at the age of 20 to 35 ,no disturbance in couples' alertness ,having written consent from the couples to participate in the research ,not having previous marriage history in each of the couples,lack of cognitive problems and special diseases in the referring people Exclusion criteria:Unwilling couples to participate in motivational interviews,unsatisfactory of couples to complete questionnaire forms incomplete data entry in the questionnaire by couples ,if motivations for interviewing are reduced in each stage of the session ,non-attending intervention sessions (one meeting and more)
Intervention groups
For 20 couples in the intervention group, the motivational interview sessions will be held in 5 sessions for 60 minutes in 5 weeks.There are no interventions for 20 couples for the control group.
Main outcome variables
Attitude

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141209020258N95
Registration date: 2019-01-13, 1397/10/23
Registration timing: retrospective

Last update: 2019-01-13, 1397/10/23
Update count: 0
Registration date
2019-01-13, 1397/10/23
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of motivational counseling on increasing couples interest for premarital genetic tests during marriage in referents to counseling center in Arak in 1396 year
Public title
The impact of motivational counseling on increasing couples interest for premarital genetic tests during marriage in referents to counseling center in Arak in 1396 year
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Couples married at the age of 20 to 35 No disturbance in couples' alertness Having written consent from the couples to participate in the research Not having previous marriage history in each of the couples Lack of cognitive problems and special diseases in the referring people
Exclusion criteria:
Unwilling couples to participate in motivational interviews Unsatisfactory of couples to complete questionnaire forms incomplete data entry in the questionnaire by couples If motivations for interviewing are reduced in each stage of the session Non-attending intervention sessions (one meeting and more)
Age
From 20 years old to 35 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with random number in division of groups in two groups A and B.The candidate patients who enter the study are randomly assigned to the randomly assigned table of randomly assigned to the two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind.Outcome elevator and analyzer are blind (double blind).Outcome elevator and analyzer don't aware from grouping.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee Of Arak University Of Medical Sciences
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Approval date
2017-11-26, 1396/09/05
Ethics committee reference number
IR.ARAKMU.REC.1396.175

Health conditions studied

1

Description of health condition studied
Genetic
ICD-10 code
D72.0
ICD-10 code description
Genetic anomalies of leukocytes

Primary outcomes

1

Description
Change attitude
Timepoint
before and 2 months after intervention
Method of measurement
Structural questionnaire based on variables of behavioral intention model included 13 general questions (demographic), 14 questions attitude, 10 awareness questions and 6 questions related to  behavioral temperament

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For 20 couples in the intervention group, the motivational interview sessions will be held in 5 sessions for 60 minutes in 5 weeks.
Category
Behavior

2

Description
Control group: There are no interventions for 20 couples for the control group.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Center Arak city marriage counseling
Full name of responsible person
Dr Katayon Vakilian
Street address
Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Phone
+98 86 3417 3505
Email
cattyV2002@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Arjmandzadegan
Street address
Research Center, Payambar Azam complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Phone
+98 86 3222 2003
Email
arjmandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Katayon Vakilian
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Midwifery and nursing department, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Phone
+98 86 3222 2003
Fax
Email
cattyv@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Hamidreza Jamilian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Amirkabir hospital, Parastar square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
Jamilian@arakmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Samaneh Shojaeefar
Position
Midwifery student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Phone
+98 86 3222 2003
Email
sa_shojaei2006@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
When we publish article in journal
When the data will become available and for how long
After the article is published
To whom data/document is available
researcher in university
Under which criteria data/document could be used
If there are additional questions
From where data/document is obtainable
Dr Jamilian
What processes are involved for a request to access data/document
They have to write letters to the professors and the university
Comments
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