Evaluation of mobile applications in the field of pregnancy healthcare and investigating the effect of selected application on knowledge and self-care skills of pregnant women
Investigating the effect of mobile phone-based self-care application on pregnancy self-care knowledge and skills
Design
A clinical trial with a control group, with parallel groups, without blinding, randomized, on 108 patients. The rand function of Excel software will be used for randomization.
Settings and conduct
This study will be conducted in Mako and Poldasht health centers.
Participants/Inclusion and exclusion criteria
Mothers who experience pregnancy for the first time; Mothers who own smart cell phones; Mothers who have a diploma to a bachelor's degree (no less than a diploma and no more than a bachelor's degree).
Intervention groups
In the current study, the intervention group will use a mobile phone-based application while receiving ongoing care from health centers. The control group will receive only the usual care provided by the health center.
Main outcome variables
Self-care knowledge and skills
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230426057997N1
Registration date:2023-05-12, 1402/02/22
Registration timing:prospective
Last update:2023-05-12, 1402/02/22
Update count:0
Registration date
2023-05-12, 1402/02/22
Registrant information
Name
Aynaz Nourani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 2307
Email address
nourani.a@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-07-21, 1402/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of mobile applications in the field of pregnancy healthcare and investigating the effect of selected application on knowledge and self-care skills of pregnant women
Public title
investigating the effect of mobile application on knowledge and self-care skills of pregnant women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers who experience pregnancy for the first time.
Mothers who own smart cell phones.
Exclusion criteria:
Mothers with less than a diploma or more than a bachelor's degree.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization
In this method, the table of random numbers will be used. A number is randomly assigned to each participant. If the number is even, the participant will be in the intervention group, and if it is odd, the participant will be in the control group.
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 Urmia University of Medical Sciences
Street address
Pardis Nazlou, 11 km of Nazlou Road,Urmia,Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2023-03-08, 1401/12/17
Ethics committee reference number
IR.UMSU.REC.1401.412
Health conditions studied
1
Description of health condition studied
Pregnancy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Self-care knowledge and skills
Timepoint
Trimester
Method of measurement
Researcher made questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Providing applications to pregnant mothers: In this intervention, a mobile application has been approved by the Scientific Association of Women and Reproductive Health, and will be available to pregnant mothers for three months. In addition to receiving common care from health centers, mothers will use this program to improve their self-care knowledge and skills. In this mobile application, educational content will be provided to pregnant mothers. These contents include common diseases and complications during pregnancy, maternal and fetal health, important times in pregnancy such as screening time, important ultrasounds, basic tests, etc.
Category
Other
2
Description
Control group: Providing routine pregnancy care from the health center
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health center of Poldasht city
Full name of responsible person
Nasrin Niknafs
Street address
Poldasht city, Sarbaz St., next to the telecommunications office, Poldasht city health center
City
Poldsht
Province
West Azarbaijan
Postal code
5877136183
Phone
+98 44 3428 2626
Email
nasrin.niknafs@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Saber Golizadeh
Street address
11th km of Saro Road - Urmia University of Medical Sciences Educational Campus - Faculty of Paramedicine
City
Urmia
Province
West Azarbaijan
Postal code
5756115198
Phone
+98 44 3275 2301
Email
saber@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia University of Medical Sciences
Proportion provided by this source
50
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
Oroumia University of Medical Sciences
Full name of responsible person
Aynaz Nourani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Informatics
Street address
11th km of Saro Road - Urmia University of Medical Sciences Educational Campus - Faculty of Paramedicine
City
Urmia
Province
West Azarbaijan
Postal code
5756115198
Phone
+98 44 3275 2306
Email
nourani.a@umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Aynaz Nourani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Informatics
Street address
11th km of Saro Road - Urmia University of Medical Sciences Educational Campus - Faculty of Paramedicine
City
Urmia
Province
West Azarbaijan
Postal code
5756115198
Phone
+98 44 3275 2306
Email
nourani.a@umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Aynaz Nourani
Position
َAssistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Informatics
Street address
11th km of Saro Road - Urmia University of Medical Sciences Educational Campus - Faculty of Paramedicine
City
Urmia
Province
West Azarbaijan
Postal code
5756115198
Phone
+98 44 3275 2306
Email
nourani.a@umsu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The documents and data of this study will be provided to the audience in the form of a final project report and article while maintaining the confidentiality and privacy of the participants.
When the data will become available and for how long
The starts time at the same time as the results are published
To whom data/document is available
All researchers
Under which criteria data/document could be used
In order to compare the results and data with the results of other applications used as an intervention in another clinical trial
From where data/document is obtainable
Applicants can refer to the Department of Health Information Technology, Urmia University of Medical Sciences, at km 11 of Sarro Road, University of Medical Sciences Campus, Faculty of Paramedicine, Dr. Aynaz Noorani.
The mobile number is 09144433526 and the postal code is 5756115198.
What processes are involved for a request to access data/document
Given that the data will remain confidential with the responsible person. Applicants can submit an application to the research vice-chancellor of the university and provide documentation related to the use of data to the research ethics committee of Urmia University of Medical Sciences and obtain data permission from the person in charge.