the comparison of effectiveness between multimedia and booklet education on uncertainty about menopause among women on menopausal transition
Design
In this research, will be selected 60 women aged 45 to 55 years old who are referred to the community health centers of the Gonabad city. Participants will be randomly divided into two groups of booklet and multimedia and A code will be allocated to each participant.
Settings and conduct
To conduct this study, after obtaining the necessary permissions to start the research and identify the research units, they will be invited to participate in the study. Before starting the study, will be explained the research objectives and will be obtained written and informed consent from all participants. At the first meeting, the mentioned questionnaires will be given to two multimedia and booklet groups. Then in the multimedia group, DVDs will be provided with educational content related to menopause. Then they will be taught how to use this DVD and a two-week timetable for viewing its training program. During these two weeks, the researcher will remind the participants, using the multimedia program by SMS. He will also provide a telephone number for them to contact the researcher if there is a problem or a question. In the booklet group, the samples will be given a booklet with exactly the same content as the multimedia package. the Knowledge and uncertainty questionnaires will be completed immediately after the intervention and one month later.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Being in the age range of 55 to 45 years. Having reading and writing skills. Desiring to participate in research.
Exit criteria: Suffering from chronic mental illness or neurological disorders. Having a hearing or visual impairment. passed a specialized training course on menopause
Intervention groups
in the multimedia group, will be provided a DVD with educational content related to menopause. Then they will be taught how to use this DVD and a two-week timetable for viewing its training program. During these two weeks, the researcher will remind the participants, using the multimedia program by SMS. He will also provide a telephone number for them to contact the researcher if there is a problem or a question. In the booklet group, the samples will be given a booklet with exactly the same content as the multimedia package.
Main outcome variables
Reduce Uncertainty in Postmenopausal Women and Promote Their Health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171025037003N2
Registration date:2018-01-29, 1396/11/09
Registration timing:retrospective
Last update:2018-01-29, 1396/11/09
Update count:0
Registration date
2018-01-29, 1396/11/09
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3028
Email address
f.afshari@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
2017-08-23, 1396/06/01
Actual recruitment end date
2017-12-11, 1396/09/20
Trial completion date
empty
Scientific title
A comparison of effectiveness between multimedia and booklet education on uncertainty about menopause among menopausal transition
Public title
A comparison of effectiveness between multimedia and booklet education on uncertainty about menopause among menopausal transition
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All women from 45 to 55 years old covered by community health centers of Gonabad city
Exclusion criteria:
Suffering from chronic mental illness or neurological disorders
Having a hearing or visual impairment
Spending a specialized training course on menopause
Age
From 45 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done by two-stage cluster sampling, so that in the first stage,from all of community health centers in Gonabad city, two centers will be randomly selected for intervention (a center for multimedia group and a center for the booklet group), And in the next stage, In each center, a list of 45-55-year-old women will be provided as a sampling frame by Using a household profile recorder, and then the research units will be randomly selected from this list.
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 Gonabad University of Medical Sciences
Street address
Asian Roads Edge - Educational and Research Deputy of Gonabad University of Medical Sciencesبا
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2017-09-27, 1396/07/05
Ethics committee reference number
IRGMUREC1396.61
Health conditions studied
1
Description of health condition studied
menopause
ICD-10 code
N95.8
ICD-10 code description
Other specified menopausal and perimenopausal disorders
Primary outcomes
1
Description
Awareness and Uncertainty in menopause
Timepoint
Before intervention, immediately after the intervention and one month later
Method of measurement
Awareness Questionnaire, Uncertainty in Menopause Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
first Intervention group: in the multimedia group, DVDs will be provided with educational content related to menopause. Then they will be taught how to use this DVD and a two-week timetable for viewing its training program. During these two weeks, the researcher will remind the participants, using the multimedia program by SMS. He will also provide a telephone number for them to contact the researcher if there is a problem or a question.
Category
Lifestyle
2
Description
Intervention group: In the booklet group, the samples will be given a booklet with exactly the same content as the multimedia package.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Gonabad Community Health Centers
Full name of responsible person
Fateme Afshari
Street address
Gonabad, Asian Roads, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 5027
Fax
+98 51 5722 3814
Email
f.afshari@gmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Narjes Bahri
Street address
Gonabad, Asian Roads, Gonabad University of Medical Sciences
City
gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
+98 51 5722 3814
Email
nargesbahri@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
fateme afshari
Position
MSc. student in nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad
City
gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
+98 51 5722 3814
Email
f.afshari@gmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr.narjes bahri
Position
Ph.D. in reproductive health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad
City
gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
+98 51 5722 3814
Email
nargesbahri@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
fateme afshari
Position
MSc. student in nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad
City
gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
+98 51 5722 3814
Email
f.afshari@gmu.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