Protocol summary

Summary
The aim is to determine the effectiveness of motivational interviewing on the adherence to iron supplementation and prenatal diagnostic test in couples suspected to have β- thalassemia, referring to premarital counseling center, Zahedan in 1394. This study is a single-blind randomized clinical trial. The population of the study are all couples who are referred to Premarital counseling center in Zahedan in 1394 . The sample size is 70 Couples. They will be allocated in intervention or control groups, randomly. Half of the couples will be held in the intervention group and half in the control group. "Block Randomization" will be used to allocate couples in the groups. Sampling will be done during four months. The main criteria for inclusion are: lack of psychological illness; participate in counseling sessions other than advice provided by the Thalassemia Advisory Centre. And exclusion criteria are: pregnant women, women with age over 45 years, illiteracy, not participation in all counseling sessions. Three counselling sessation (motivational interview) that each one will last about 90-minute will be held for each couples. One months later, the number, type and dose of iron tablets that are intake by couples, As well, the MCV, MCH, and HbA2 Will be considered. And each couple for doing prenatal diagnostic tests will be followed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015061022651N1
Registration date: 2015-08-01, 1394/05/10
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-08-01, 1394/05/10
Registrant information
Name
Zahra Moudi
Name of organization / entity
Zahedan University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 341 1005
Email address
moudi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University Of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-10-22, 1394/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of effect of motivational interviewing on adherence to iron supplementation and prenatal diagnostic test in couples suspected to have β- thalassemia, referring to premarital counseling center, Zahedan
Public title
The study of effect of motivational interviewing on adherence to iron supplementation and prenatal diagnostic test in couples suspected to have β- thalassemia, referring to pemarital counseling center, Zahedan
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria: lack of psychological illness; participate in counseling sessions other than advice provided by the Thalassemia Advisory Centre. Exclusion criteria:: pregnant women, women with age over 45 years, illiteracy, not participation in all counseling sessions.
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
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
zahedan university of Medical Sciences
Street address
field doctor hesabi - College of Medical Sciences
City
zahedan
Postal code
۹۸۱۶۷۴۳۴۶۳
Approval date
2015-05-31, 1394/03/10
Ethics committee reference number
IR.ZAUMS.REC.1394.102

Health conditions studied

1

Description of health condition studied
Haemolytic anaemias
ICD-10 code
D56.1
ICD-10 code description
Beta thalassaemia

Primary outcomes

1

Description
The first stage of prenatal diagnosis test
Timepoint
Two months after the intervention
Method of measurement
Couples cases

Secondary outcomes

1

Description
Measurement Of MCV
Timepoint
Before and one month after intervention
Method of measurement
Check tests

2

Description
Adherence to iron supplementation
Timepoint
One month after the intervention
Method of measurement
Asked about the number of iron consumption

3

Description
Measurement Of MCH
Timepoint
Before and one month after
Method of measurement
Check tests

4

Description
Measurement of HbA2
Timepoint
Before and one month after
Method of measurement
Check tests

Intervention groups

1

Description
Control group received only routine counseling in Premarital counseling center.
Category
Other

2

Description
Apart from routine advice in Premarital counseling center, three 90-minute sessions of individual counseling, motivational interviewing intervention group held.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Premarital Counseling Center
Full name of responsible person
Mansore Havashenas
Street address
Premarital Counseling Center, Crossroads Modarres
City
Zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Assistant Zahedan University of Medical Sciences
Full name of responsible person
Hoshang Rafighdost
Street address
Field docter Hesabi, Zahedan University of Medical Sciences
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Assistant Zahedan University of Medical Sciences
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
Zahedan University of Medical Sciences
Full name of responsible person
Esmat Dehghani
Position
Masters student in the field Consultation of midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Square Of Mashahir, Zahedan
City
Zahedan
Postal code
9816913396
Phone
+98 33442482
Fax
+98 54 3344 2481
Email
Dehghani_1361@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Zahra Moudi
Position
PhD in Reproductive Health
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Square Of Mashahir, Zahedan
City
Zahedan
Postal code
9816913396
Phone
+98 54 3344 2482
Fax
+98 54 3344 2481
Email
Moudi@zaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Esmat Dehghani
Position
Masters student in the field consultationof midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Square Of Mashahir, Zahedan
City
Zahedan
Postal code
9816913396
Phone
+98 33442482
Fax
+98 54 3344 2481
Email
Dehghani_1361@yahoo.com
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
empty
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