Protocol summary

Summary
Objectives: this study will be performed to determine the effect of individual and group education on informed choice of pregnant women about screening of fetal chromosomal abnormalities. Design: the study is a randomized controlled. Setting and conduct: 240 pregnant women will participate in it. The research will be done in three health centers in Mashhad that are similar from social and economic context, in two intervention groups and control group. Major Inclusion and Exclusion criteria: Muslim and Iranian, consent to participate in research, gestational age less than 10 weeks, have at least five elementary education, having full consciousness and the ability to receive auditory and speech training and answer questions, lack of indication for diagnostic tests, not being a member of the health team. Exclusion criteria: absence in one of the training sessions, leave the class before the end of training, lack of The desire to continue participating in the study, fetal death during the study, occurring unpleasant events during training sessions. Intervention: initially all participants will complete questionnaires ( demographic, informed choice, anxiety, decision conflict and well-being) .Individual and group training presented to both groups during two consecutive weeks in two sessions. control group will receive usual care in two consecutive weeks. Further questionnaires will be completed in 20- 22 weeks of pregnancy.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2014081318785N1
Registration date: 2015-08-03, 1394/05/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-08-03, 1394/05/12
Registrant information
Name
Sahar Riyazi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3270 9157
Email address
riyaziz911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of group and individual Education on informed choice of pregnant women about screening tests of fetal chromosomal disorders
Public title
Comparison of effect of group and individual Education on informed choice of pregnant women about screening tests of fetal chromosomal disorders
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Muslim and Iranian; Consent to participate in research; Gestational age less than 10 weeks; Have at least five elementary education; Having full consciousness and the ability to receive auditory and speech training and answer questions; Lack of indication for diagnostic tests; Not being a member of the health team. Exclusion criteria: Absence in one of the training sessions; Leave the class before the end of training; Lack of The desire to continue participating in the study; Fetal death during the study; Occurring unpleasant events during training sessions.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 240
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization method will be blocked.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Daneshgah Street, Central Organization of Mashhad University of Medical Sciences
City
Mashhad
Postal code
9177899191
Approval date
2014-07-15, 1393/04/24
Ethics committee reference number
research/922882/1/12

Health conditions studied

1

Description of health condition studied
Antenatal Screening
ICD-10 code
Z36
ICD-10 code description
Routine Prenatal Care

Primary outcomes

1

Description
Informed Choice
Timepoint
Before Intervention and Three Months after Intervention
Method of measurement
Informed Choic Scale

Secondary outcomes

1

Description
Worry
Timepoint
Before Intervention and Three Months after Intervention
Method of measurement
Cambridge Worry Questionnaire

2

Description
Anxiety
Timepoint
Before Intervention and Three Months after Intervention
Method of measurement
Spielberger Questionnaire

3

Description
Decisional Conflict
Timepoint
Before Intervention and Three Months after Intervention
Method of measurement
Decisional Conflict Questionnaire

4

Description
Well Being
Timepoint
Before Intervention and Three Months after Intervention
Method of measurement
WHO-5-Well Being Questionnaire

Intervention groups

1

Description
control group: the usual care was conducted in two consecutive weeks.
Category
Behavior

2

Description
Intervention group 1: In the individual education, screening and diagnostic information Will be presented to face to face method in during two sessions of 45 to 60 minutes and in two consecutive weeks.
Category
Behavior

3

Description
Intervention group 2: In the group education, screening and diagnostic information Will be presented to lecture method in during two sessions of 45 to 60 minutes and in two consecutive weeks.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
health center No.3 Mashhad
Full name of responsible person
Baratali Arabnejad
Street address
Akhond Khorasani Street, Mashhad
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Daneshgah Street, Central Organization of Mashhad University of Medical Sciences
City
Mashhad
Grant name
-
Grant code / Reference number
922882
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Sahar Riyazi
Position
MSc Midwifery
Other areas of specialty/work
Street address
خیابان دانشگاه، خیابان ابن سینا
City
Mashhad
Postal code
9146666447
Phone
+98 51 3270 9157
Fax
-
Email
riyaziz911@mums.ac.ir
Web page address
-

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoumeh Kordi
Position
MSc Midwifery
Other areas of specialty/work
Street address
Ebne Sina Street, Danashgah Street
City
Mashhad
Postal code
9177899191
Phone
+98 51 1859 1511
Fax
-
Email
kordiM@mums.ac.ir
Web page address
-

Person responsible for updating data

Contact
Name of organization / entity
Doktora Crossroad. Ebne Sina Street
Full name of responsible person
Sahar Riyazi
Position
MSc Midwifery
Other areas of specialty/work
Street address
Ebne Sina Street, Danashgah Street
City
Mashhad
Postal code
9146666447
Phone
+98 51 3270 9157
Fax
-
Email
riyaziz911@mums.ac.ir
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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