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The effect of premarital counseling through motivational Interview on the knowledge, attitude and intention to refer to couples in need of genetic counseling

Protocol summary

Study aim
Determining the effect of premarital counseling through motivational Interview on the knowledge, attitude and intention to refer to couples in need of genetic counseling
Design
A clinical trial with a control group with parallel groups, without blinding, randomized, on 70 patients
Settings and conduct
This study is a clinical trial. Couples will be selected from Mashhad health centers. After completing the questionnaires, they are divided into two intervention and control groups by random allocation. In addition to routine care, the intervention group will receive three sessions of 60-90 minutes, once a week, pre-marital counseling based on motivational interview.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Iranian couple,Having at least primary education , Do not have addiction to tobacco and alcohol , Having an Android phone , Based on the doctor's approval and the genetic screening questionnaire, they should have a genetic counseling indication at the time of marriage , Couples who do not intend to do genetic counseling.Exclusion criteria: Diagnosis of a known psychiatric disorder in the couple (having a mood and anxiety disorder and being treated), Uncertainty about continuing the research
Intervention groups
Intervention group: couples will receive three counseling sessions based on motivational interviewing for 60-90 minutes once a week in one face-to-face session and two online sessions in groups of 4-5 couples.The control group will receive routine care according to the instructions of the social genetics program, which includes training and identification and follow-up of couples in need of genetic counseling.
Main outcome variables
knowledge, attitude and intention to refer

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221022056264N1
Registration date: 2023-02-04, 1401/11/15
Registration timing: registered_while_recruiting

Last update: 2023-02-04, 1401/11/15
Update count: 0
Registration date
2023-02-04, 1401/11/15
Registrant information
Name
Maryam Imani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3605 4850
Email address
imanimr3@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-31, 1401/10/10
Expected recruitment end date
2023-04-30, 1402/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of premarital counseling through motivational Interview on the knowledge, attitude and intention to refer to couples in need of genetic counseling
Public title
The effect of motivational interviewing on couples in need of genetic counseling
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian couple Have at least primary education. Do not have addiction to tobacco and alcohol Have an Android phone. Based on the doctor's approval and the genetic screening questionnaire, they should have a genetic counseling indication at the time of marriage. Couples who do not intend to do genetic counseling.
Exclusion criteria:
Diagnosis of a known psychiatric disorder in the couple (having a mood and anxiety disorder and being treated) Uncertainty about continuing the research
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation: using the website www.random.org and through blocking with block sizes of four and six and an allocation ratio of 1:1 to the two groups of counseling and control.
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 the School of Nursing and Midwifery Mashhad University of Medical Sciences
Street address
Qurashi Building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2022-10-04, 1401/07/12
Ethics committee reference number
IR.MUMS.NURSE.REC.1401.070

Health conditions studied

1

Description of health condition studied
Family history of mental retardation
ICD-10 code
Z81.0
ICD-10 code description
Family history of mental retardation (Conditions classifiable to F70-F79)

Primary outcomes

1

Description
Knowledge score in the knowledge questionnaire
Timepoint
The measurement periods will be before the intervention, immediately after the end of the intervention and one month after the intervention.
Method of measurement
Knowledge questionnaire ( Researcher made )

2

Description
Attitude score in the attitude questionnaire
Timepoint
The measurement periods will be before the intervention, immediately after the end of the intervention and one month after the intervention.
Method of measurement
Attitude questionnaire based on Zaien study

3

Description
Referral intention score in the questionnaire
Timepoint
The measurement periods will be before the intervention, immediately after the end of the intervention and one month after the intervention.
Method of measurement
Referral intention questionnaire ( Researcher made )

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention will be implemented in three sessions once a week for 60-90 minutes, one face-to-face session and two online sessions in groups of 4-5 couples. In the first meeting, greeetings, stating the rules and goals of the meeting, encouraging couples to express their information, feelings and beliefs about genetic counseling and genetic diseases, introducing a motivational approach; Expressing the effects of having a baby with a genetic disorder in different aspects of life; Introducing the stages of change and doing exercises (thinking and reflection stage) and in the second session, answering the doubts and questions formed in the minds of couples and examining the existing problems and obstacles and the causes of resistance to genetic counseling, determining the advantages and disadvantages of changing behavior. The short-term evaluation of the advantages and disadvantages of genetic counseling (readiness to change behavior and action) and the third session of empowerment (transmission of correct information) and support, review of values, perspective and conclusions are expressed (maintenance stage).
Category
Behavior

2

Description
Control group: They will receive routine care provided in Mashhad health centers number 1 and 2, which includes education about 6 genetic diseases (Duchen and Becker, Down syndrome, sickle cell anemia, G6PD, neural tube defects, hemophilia) and identification and follow-up of couples in need of genetic counseling.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Center No. 1
Full name of responsible person
Maryam Imani
Street address
Between 66 and 68 Vakil Abad, Vakil Abad Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٧٩٧٩٣٩۴۵
Phone
+98 51 3801 5011
Email
imanimr3@mums.ac.ir

2

Recruitment center
Name of recruitment center
Health Center No. 2
Full name of responsible person
Maryam Imani
Street address
No. 2, Mashhad Health Center , Panjarah
City
Mashhad
Province
Razavi Khorasan
Postal code
9153913153
Phone
+98 51 3365 3000
Email
imanimr3@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Ghayor Mobarhan
Street address
Research and Technology Vice-Chancellor, Qurashi Building next to Hoizeh Cinema, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
GhayourM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Nahid Jahani Shurab
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery , Ibn Sina St., , Ph.D.Intersection,Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
jahaniShN@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nahid Jahani Shurab
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery , Doctor's intersection , Ibn Sina St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
jahaniShN@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Imani
Position
Master's student in counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
College of Nursing and Midwifery , Doctor's Crossroads
City
Mashhad
Province
Razavi Khorasan
Postal code
9188667656
Phone
+98 51 3605 4850
Email
imanimr3@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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