Determining the effect of implementing an educational program on mental health-seeking behaviors in women with high-risk pregnancies
Design
A clinical trial with a parallel randomized control group, not blinded, on 224 high-risk pregnant women.
Settings and conduct
High-risk pregnant women referring to Imam Khomeini hospital clinic in Ahvaz, who were randomly divided into intervention and control groups (112 people in each group).
Participants/Inclusion and exclusion criteria
Be able to understand Persian speech and writing
Be a resident of Ahvaz
Having a mobile phone
Failure to enter: self-reporting of mental disorder and taking psychiatric drugs
Intervention groups
The intervention group with a volume of 112 high-risk pregnant women will undergo a training program with a specified number of sessions. Questionnaires will be provided to them before and after the intervention to be completed, and for the control group, after the completion of the intervention, educational materials will be provided in order to comply with ethics. They will be placed
Main outcome variables
Promotion of health behaviors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200126046262N1
Registration date:2024-08-05, 1403/05/15
Registration timing:prospective
Last update:2024-08-05, 1403/05/15
Update count:0
Registration date
2024-08-05, 1403/05/15
Registrant information
Name
safieh jamali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 5503
Email address
safieh_jamali@yahoo.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-10-21, 1403/07/30
Expected recruitment end date
2026-03-20, 1404/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of an educational program based on health-seeking behaviors on promoting health behaviors in high-risk pregnant women
Public title
Investigating the effect of educational program on promoting health behaviors in high-risk pregnant women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women with one or more chronic diseases that are diagnosed before pregnancy, with continued recurrence and the need for medical treatment, such as: epilepsy, high blood pressure, lung disease, thyroid disease, diabetes, etc. ...
Be able to understand Persian speech and writing.
Be a resident of Ahvaz
Exclusion criteria:
Self-reporting of drug and alcohol abuse history
Self-report of mental disorder and psychiatric medication use
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
224
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be randomly assigned to the intervention and control groups in a ratio of 1:1. Allocation sequence production will be done by specifying the sample size of 112 people in each group and the random block type, random block (4 and 6). The sequence of allocation and preparation of opaque envelopes will be done by a statistician. The researcher and the samples will not be blinded to the allocation.
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 Ahvaz University of Medical Sciences
Street address
Jandishapur University of Ahvaz,Golestan Ahvaz,iran,
City
ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2024-07-19, 1403/04/29
Ethics committee reference number
IR.AJUMS.REC.1403.173
Health conditions studied
1
Description of health condition studied
high risk pregnancy
ICD-10 code
z35.3
ICD-10 code description
Supervision of pregnancy with history of insufficient antenatal care
Primary outcomes
1
Description
Uncertainty score in high-risk pregnancy uncertainty questionnaire
Timepoint
Before starting the intervention and after finishing the training sessions
Method of measurement
Questionnaire of uncertainty in high-risk pregnancy
2
Description
Stress score in perceived stress questionnaire
Timepoint
Before starting the intervention and after finishing the training sessions
Method of measurement
Perceived stress scale- 4 items (PSS-4)
3
Description
Coping behaviors
Timepoint
Before starting the intervention and after finishing the training sessions
Method of measurement
Coping strategies questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A sample size of 112 high-risk pregnant women will be enrolled in the study with written consent. The educational intervention is based on health-seeking behaviors, which includes sessions based on topics related to stress management methods, coping mechanisms, and supportive information regarding high-risk pregnancy. Before and after the intervention, questionnaires measuring stress, uncertainty, and copingstrategies will be provided to the participants for completion.
Category
Behavior
2
Description
Control group: Control group: A sample size of 112 individuals will enter the study with written consent. The samples will not undergo any educational program. Before and after completion, they will fill out questionnaires on stress, uncertainty, and coping strategies, and at the end of the study, all educational content will be provided to them.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomani Hospital
Full name of responsible person
Safieh Jamali
Street address
Jandishapur University of Ahvaz,Golestan Ahvaz,iran,
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8620
Fax
+98 61 3373 8620
Email
Safieh_jamali@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakir Kish
Street address
Jandishapur University of Ahvaz,Golestan Ahvaz,iran,
City
ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 2944
Fax
+98 61 3311 2944
Email
safieh_jamali@yahoo.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Ahvaz University of Medical Sciences
Full name of responsible person
Safieh Jamali
Position
Student in phd midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Jandishapur University of Ahvaz,Golestan Ahvaz,iran,
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 2944
Fax
+98 61 3311 2944
Email
Safieh_jamali@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Safieh Jamali
Position
Student of Phd Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Jandishapur University of Ahvaz,Golestan Ahvaz,iran,
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 3815
Fax
+98 71 5434 0406
Email
safieh_jamali@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Safieh Jamali
Position
Student of Phd Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Jandishapur University of Ahvaz,Golestan Ahvaz,iran,
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 3815
Fax
+98 61 3311 3815
Email
safieh_jamali@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
All data related to the study and including the main outcome will be published in the majority of the article.
When the data will become available and for how long
Access to the data will begin after the publication of the articles resulting from the plan
To whom data/document is available
Researchers who work in this field can have access.
Under which criteria data/document could be used
They can access my documents to conduct research such as systematic articles and similar works
From where data/document is obtainable
I, who am the main researcher and responsible, can be contacted through email and contact number.
safieh_jamali@yahoo.cim
009809173061189
What processes are involved for a request to access data/document
After the publication of the articles related to the project, any researcher can contact me by e-mail or contact me 4 months later and the documents will be available to her