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The effect of telephone education based on the health belief model, on abortion among married mothers who are prone to abortion

Protocol summary

Study aim
Determining the effect of telephone training,based on the health belief model, on the intention to have an abortion among married and abortion-prone mothers
Design
The clinical trial has a control group,with parallel groups, one-sided blind, randomized using random table numbers
Settings and conduct
The research will be conducted in health service centers.The participants do not know how to be placed in the intervention or control group.The intervention group will be trained
Participants/Inclusion and exclusion criteria
Inclusion criteria:Iranian nationality, desire and informed consent , gestational age under14 weeks, married and officially married, residence of Isfahan, Women who are mentally healthy .Exclusion criteria:women who intend to leave the study during or after receiving training
Intervention groups
Married women who are inclined to undergo induced abortion are trained by the researcher in order to make the right decision to continue the pregnancy,in a virtual way (through the educational hotline) and based on the content set based on the constructs of the health belief model.Before providing training, their intention to perform induced abortion is asked through questionnaires prepared in this field.In these educational packages, in addition to the content (complications of abortion and the benefits of continued pregnancy),images and videos related to the complications of induced abortions are also shown.The control group only receives the complications of abortion in the form of a prepared pamphlet for the purpose of increasing knowledge.1 week after the training, the researcher will contact both groups and complete the mentioned questionnaires again
Main outcome variables
Perceived sensitivity score, perceived threat score, perceived barriers score, perceived benefits score, self-efficacy score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221129056664N1
Registration date: 2022-12-17, 1401/09/26
Registration timing: prospective

Last update: 2022-12-17, 1401/09/26
Update count: 0
Registration date
2022-12-17, 1401/09/26
Registrant information
Name
Zahra Sohrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7546
Email address
zsohrabi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of telephone education based on the health belief model, on abortion among married mothers who are prone to abortion
Public title
The effect of telephone education based of Belief Model on abortion of married and abortion-prone mothers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Have Iranian nationality Women who have a desire and informed consent to participate in the study The gestational age of women is less than 14 weeks Be married and officially married Be a resident of Isfahan city Women who are mentally healthy
Exclusion criteria:
Women who intend to drop out during or after receiving training.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
The researcher randomly selects 3 centers out of 5 comprehensive health centers through lottery. Sampling of people is done in an easy way from people who meet the criteria to enter the study, and then they are randomly placed in two intervention and control groups using a table of random numbers. Even numbers will be in the intervention group and odd numbers will be in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this research, the participants are completely unaware of whether they are in the intervention or control group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Approval date
2022-11-22, 1401/09/01
Ethics committee reference number
IR.MUI.NUREMA.REC.1401.108

Health conditions studied

1

Description of health condition studied
Abortion of mothers
ICD-10 code
O00-O08
ICD-10 code description
Pregnancy with abortive outcome

2

Description of health condition studied
Other abortion
ICD-10 code
005
ICD-10 code description
Other abortion

Primary outcomes

1

Description
Perceived sensitivity score
Timepoint
It will be done once before the educational intervention and once a week after the intervention
Method of measurement
Researcher made Questionnaire

2

Description
Perceived threat score
Timepoint
It will be done once before the educational intervention and once a week after the intervention
Method of measurement
Researcher made Questionnaire

3

Description
Perceived barriers score
Timepoint
It will be done once before the educational intervention and once a week after the intervention
Method of measurement
Researcher made Questionnaire

4

Description
Perceived benefits score
Timepoint
It will be done once before the educational intervention and once a week after the intervention
Method of measurement
Researcher made Questionnaire

5

Description
Self-efficacy score
Timepoint
It will be done once before the educational intervention and once a week after the intervention
Method of measurement
Researcher made Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Married women who are inclined to undergo induced abortion are trained by the researcher in order to make the right decision to continue the pregnancy, in a virtual way (through the educational hotline) and based on the content set based on the constructs of the health belief model. Before providing training, their intention to perform induced abortion is asked through questionnaires prepared in this field. The duration of training in the intervention group is estimated to be 1 to 1 and a half hours. It should be noted that if the intervention group asked for more description of the training or the researcher thought that they needed more explanation to better understand the content, the training packages will be prepared based on the results of the expert panel and will be available on Itai channel. Researchers are also trained.In these educational packages, in addition to the content (complications of abortion and the benefits of continued pregnancy), images and videos related to the complications of induced abortions are also shown, while the research samples can have questions and answers with the researcher. The control group only receives the complications of abortion in the form of a prepared pamphlet for the purpose of increasing knowledge. 1 week after the training (due to the possibility of immediate decision of the mothers to have an abortion), the researcher will contact both groups and complete the mentioned questionnaires again.Questionnaires will be completed once before the intervention and again 1 week after the training (according to the possibility of immediate decision of mothers to have an abortion). Due to the completion of the questionnaires by the researcher, we can be sure that the questionnaires will be completed completely. Also, through the presentation of gifts that will be delivered by comprehensive health service centers, the participation of people will be attracted to complete the questionnaires.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Nawab Comprehensive Health Services Center
Full name of responsible person
Zahra Sohrabi
Street address
Ahmad Abad Ave,. Nawab Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3227 5358
Email
zsohrabi@nm.mui.ac.ir

2

Recruitment center
Name of recruitment center
Ibn Sina Comprehensive Health Services Center
Full name of responsible person
Zahra Sohrabi
Street address
Ibn Sina َAve., Shohada blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3445 9147
Email
zsohrabi@nm.mui.ac.ir

3

Recruitment center
Name of recruitment center
Amir Hamzeh Comprehensive Health Services Center
Full name of responsible person
Zahra Sohrabi
Street address
Amirhamzeh Ave., Meisami Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3775 7509
Email
zsohrabi@nm.mui.ac.ir

4

Recruitment center
Name of recruitment center
Waliasr Comprehensive Health Service Center
Full name of responsible person
Zahra Sohrabi
Street address
Amirieh Ave., Meisami Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3775 7509
Email
zsohrabi@nm.mui.ac.ir

5

Recruitment center
Name of recruitment center
Dastgard Comprehensive Health Service Center
Full name of responsible person
Zahra Sohrabi
Street address
Dastgard Ave., Ghaemieh Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3780 8847
Email
zsohrabi@nm.mui.ac.ir

6

Recruitment center
Name of recruitment center
Khajo Comprehensive Health Service Center
Full name of responsible person
Zahra Sohrabi
Street address
Khajo Ave., Khajo Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3273 4010
Email
zsohrabi@nm.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Sohrabi
Street address
Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3792 7546
Email
zsohrabi@nm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Sohrabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3792 7546
Email
zsohrabi@nm.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Sohrabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3792 7546
Email
zsohrabi@nm.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Sohrabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Phone
009837927546
Email
zsohrabi@nm.mui.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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