Designing a menopausal self-care application and examining its effect on the severity of menopausal symptoms in postmenopausal women referring to health centers in Jiroft in 2020
Determining the effect of menopause application on the severity of menopausal symptoms
Design
Clinical trial with control group, without blinding, randomized, On 60 menopausal women, A simple random method will be used for randomization.
Settings and conduct
After random selection of people referring to health centers in Jiroft,, explanation of goals and obtaining informed consent, the pre-test questionnaire will be completed by both groups (intervention and control). Then, the application made via Bluetooth will be installed on the smartphones of the people in the intervention group and they will be taught how to use it. After two and eight weeks (two stages), the questionnaire will be given and completed again as a post-test by going home or inviting women to health centers.
Participants/Inclusion and exclusion criteria
Admission: Age 45 to 60
Complete cessation of menstruation in the last 12 months without the use of medication or surgery
Literacy and access to smart phones
Withdrawal: Use any medication to reduce menopausal symptoms
Having any mental illness
Intervention groups
Intervention group: an application made via Bluetooth will be installed on their smartphone. In fact, the intervention is educational-consulting content available in the application.
Control group: will receive routine care.
Main outcome variables
Severity of menopausal symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201226049833N1
Registration date:2021-05-28, 1400/03/07
Registration timing:registered_while_recruiting
Last update:2021-05-28, 1400/03/07
Update count:0
Registration date
2021-05-28, 1400/03/07
Registrant information
Name
Najmeh Pourshahrokhi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 4331 6719
Email address
n.pourshahrokhi95@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-06-21, 1400/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing a menopausal self-care application and examining its effect on the severity of menopausal symptoms in postmenopausal women referring to health centers in Jiroft in 2020
Public title
The effect of menopausal self-care application on the severity of menopausal symptoms in postmenopausal women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 45 to 60
Complete cessation of menstruation in the last 12 months without the use of medication or surgery
Literacy and access to smart phones
Exclusion criteria:
Use any medication to reduce menopausal symptoms
Having any mental illness
Age
From 45 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
To assign people to two groups, cards called control A and intervention B will be designed and these cards will be placed in an envelope and the person will randomly pick up a card from the envelope. If he picks up card A, he enters the control group and if he picks up card B, he enters the intervention 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 Jiroft University of Medical Sciences
Street address
Jiroft - Sepah Square - Nomadic Martyrs Building - Headquarters of Jiroft University of Medical Sciences and Health Services
City
jiroft
Province
Kerman
Postal code
7861634204
Approval date
2020-04-26, 1399/02/07
Ethics committee reference number
IR.JMU.REC.1399.011
Health conditions studied
1
Description of health condition studied
Severity of menopausal symptoms
ICD-10 code
N95
ICD-10 code description
Menopausal and other perimenopausal disorders
Primary outcomes
1
Description
Severity of menopausal symptoms
Timepoint
Before starting the study And after the intervention in two shifts, the second and eighth week will be measured.
Method of measurement
Menopause Rating Scale (MRS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For members of the intervention group, an application made via Bluetooth will be installed on their smartphones and they will be taught how to use them. In fact, our study intervention is educational-consulting materials available in the application, which will be provided to the intervention group for 8 weeks.Content of educational-counseling materials in the form of multimedia contents such as video, image and audio and with graphic and visual features appropriate to the age group of adults, including education on physical and mental symptoms of postmenopausal women and ways to reduce them, nutrition, exercise, Personal hygiene, sexual issues, supplementation and danger signs of women in this period. No training session will be held. The application was designed and implemented with the cooperation of two gynecologists, two senior midwives, two psychiatrists, one medical informatics specialist and two software experts.In order to develop the application under the Android platform using the Java language, the technical requirements for this purpose will be identified and first the trial version and then the final version of the application will be created. The application can be easily installed and run with common hardware. Researchers will be in touch with members of the intervention group by telephone and will contact them twice a week, asking them to read the contents of the application, and if the members of the intervention group have any questions, They respond and encourage them to read the content in the app
Category
Other
2
Description
Control group: The created application will not be available to the control group and they will receive the usual care for postmenopausal women. Routine care includes care such as blood pressure control for all middle-aged men and women in health centers.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Jiroft Comprehensive Urban Health Service Center No. 3 Shahid Beheshti
Full name of responsible person
Farzaneh Barkhouri
Street address
Pasdaran 10 Comprehensive Urban Health Service Center No. 3 Pasdaran Blvd.Jiroft.kerman
City
jiroft
Province
Kerman
Postal code
7861756447
Phone
+98 34 4331 5084
Email
n.pourshahrokhi95@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jeeroft University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research and Technology of Jiroft University of Medical Sciences
Street address
Jiroft - Pasdaran Boulevard - Vice Chancellor for Research and Technology, Jiroft University of Medical Sciences and Health Services
City
jiroft
Province
Kerman
Postal code
7861634204
Phone
+98 34 4331 7803
Email
n.pourshahrokhi95@jmu.ac.ir
Web page address
Grant name
Vice Chancellor for Research and Technology of Jiroft University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jeeroft 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
Jeeroft University of Medical Sciences
Full name of responsible person
Neda Dastyar
Position
coach
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Jiroft - Shahed Square of Jiroft University of Medical Sciences and Health Services
City
jiroft
Province
Kerman
Postal code
7861756447
Phone
+98 34 4331 6490
Email
dr.neda@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jeeroft University of Medical Sciences
Full name of responsible person
Neda Dastyar
Position
Faculty
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Jiroft - Shahed Square of Jiroft University of Medical Sciences and Health Services
City
jiroft
Province
Kerman
Postal code
7861756447
Phone
+98 34 4331 6490
Email
dr.neda@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Jeeroft University of Medical Sciences
Full name of responsible person
najmeh pourshahrokhi
Position
Director of Virtual Training Center
Latest degree
Master
Other areas of specialty/work
Medical Informatics
Street address
Shahed Square Jiroft University of Medical Sciences
City
jiroft
Province
Kerman
Postal code
7861756447
Phone
43317302 - 034
Fax
+98 34 4331 6790
Email
n.pourshahrokhi95@gmail.com
Web page address
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
After the data is not identifiable, part of the data related to the main outcome of the study will be published.
When the data will become available and for how long
Start of access period from article printing up to 6 months after
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
If you send a written request from the academic and scientific institutions, data file unrecognizable to them and they will be allowed to perform paired t-test, independent t-test, chi-square test and analysis of covariance are.
From where data/document is obtainable
A written request should be sent by the University and Scientific Institute with the name and personal details to the e-mail address n.pourshahrokhi95@gmail.com.
What processes are involved for a request to access data/document
First, a written request will be sent to the mentioned e-mail address, and after reviewing the request by the relevant person, and within 2 weeks, the result will be sent to the requesting person via e-mail.