- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06413875
Effectiveness of Education Specific to Menopause Symptoms
The Effect of Menopausal Symptoms Specific Education Given to Women in Menopause Via WhatsApp on Quality of Life and Genital Self-Image
Objective: To determine the effect of menopausal symptom-specific education given to menopausal women via WhatsApp on their quality of life and genital self-image.
Methods: The population of the study, which has a classical experimental design with a pretest-posttest control group, was comprised of women between the ages of 45-65 across Turkey. According to the power analysis performed in the G*Power3.1 Program, the sample size was calculated as 64 participants for each group, with an effect size (0.418), 95% power and 0.05 type 1 error, and was completed with 158 women. Data were collected with the Introductory Information Form, the Menopause-Specific Quality of Life Scale (MSQLS) and the Female Genital Self-Image Scale (FGSIS). The research was conducted online via WhastApp in a pretest-educational intervention-posttest design. The data were analyzed in the SPSS 26.0 package program.
Study Overview
Detailed Description
Objective: To determine the effect of menopausal symptom-specific education given to menopausal women via WhatsApp on their quality of life and genital self-image.
Methods: The population of the study, which has a classical experimental design with a pretest-posttest control group, was comprised of women between the ages of 45-65 across Turkey. According to the power analysis performed in the G*Power3.1 Program, the sample size was calculated as 64 participants for each group, with an effect size (0.418), 95% power and 0.05 type 1 error, and was completed with 158 women. Data were collected with the Introductory Information Form, the Menopause-Specific Quality of Life Scale (MSQLS) and the Female Genital Self-Image Scale (FGSIS). The research was conducted online via WhatsApp between April and December 2023, using the snowball sampling method with participants who met the inclusion criteria. In snowball sampling, first of all, contact was made with one of the units of the universe. With the help of the contacted unit, a third unit was contacted. In this way, the sample size expanded like a snowball growing. First, the participants around the researchers were reached, and then the participants' circle was reached. The data collection form was sent online to the participants in the sample and they were asked to fill it out (pre-test). Two separate groups were opened on WhatsApp for the intervention and control groups. It has been stated in the literature that video and informative message interventions performed three days a week for 3-6 weeks are effective. For this reason, in this study, the educational intervention included sending an informative video once a week and informative messages three days a week for four weeks.18,19 In the intervention part of the study, after all participants filled out the data collection form, the intervention group was informed about Menopause once a week on the first day of each week for four weeks. An information video prepared in line with the topics specified in the Symptom-Specific Training Booklet has been sent. Informative messages were sent via WhatsApp three days a week, in parallel with the training topic of each week (training intervention). No educational intervention was given to the control group. After the training, a data collection form was sent to both the intervention and control groups via WhatsApp and the participants were asked to fill it out again (posttest). After the final test phase of the research was completed, training videos and informative messages were sent to the participants in the control group via WhatsApp. The data collection form was filled out using the self-report method in approximately 10 minutes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Bartin, Turkey, 74100
- Ebru Cirban Ekrem
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- between the ages of 45-65 between April and December 2023,
- in the pre/peri/postmenopausal period,
- not receiving hormone replacement therapy in the last 6 months,
- not having had a gynecological operation,
- women who have internet access, (6) use a smartphone,
- voluntarily agree to participate in the study.
Exclusion Criteria:
- Those who filled out the data collection form incompletely
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: enterprise group
The data collection form was sent online to the participants in the sample and they were asked to fill it out (pre-test).
Two separate groups were opened on WhatsApp for the intervention and control groups.
For this reason, in this study, the educational intervention included sending an informative video once a week and informative messages three days a week for four weeks.In the intervention part of the study, after all participants filled out the data collection form, the intervention group was informed about Menopause once a week on the first day of each week for four weeks.
An information video prepared in line with the topics specified in the Symptom-Specific Training Booklet has been sent.
Informative messages were sent via WhatsApp three days a week, in parallel with the training topic of each week (training intervention).After the training, a data collection form was sent to the intervention group via WhatsApp and the participants were asked to fill it out again (posttest).
|
Education Specific to Menopause Symptoms
|
No Intervention: control group
The data collection form was sent online to the participants in the sample and they were asked to fill it out (pre-test).
No educational intervention was given to the control group.
After the training, a data collection form was sent to the control group via WhatsApp and the participants were asked to fill it out again (posttest).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The total quality of life scale score of the intervention group that received training on menopause symptoms was better than the control group.
Time Frame: 4 weeks
|
Education Specific to Menopause Symptoms
|
4 weeks
|
The genital self-image scale total score of the intervention group that received training on menopause symptoms was better than the control group.
Time Frame: 4 weeks
|
Education Specific to Menopause Symptoms
|
4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- makale
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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