Postmenopausal SymptomsNCT05659693
The Effect of Digital Literacy Education Given to Postmenopausal Women on Health Literacy and Quality of Life
A study testing digital literacy education specific to menopause in people with Postmenopausal Symptoms and Literacy, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
During menopause, women may experience many conditions and symptoms due to fluctuation in hormone levels. These symptoms can affect a woman's social and personal functioning and quality of life. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Symptoms, Literacy, Quality of Life
- What is being tested?
- digital literacy education specific to menopause
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2022to 10 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being between 45 - 65 years old,
- Being in the postmenopausal period
- Using a smart phone, tablet and/or computer
- Digital literacy level of 3.40 and below
Who cannot join
- Having a diagnosed psychiatric disorder
- Having a diagnosed cancer disease
- Scale item total score is in the high range between 3.41-4.20 and very high between 4.21-5.00 (Ng, 2012).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İstanbul university -cerrahpaşa, faculty of nursing
Istanbul, 34000
selcan bakır, +905389586702, selcanbakir244@gmail.com
About this study
During menopause, women may experience many conditions and symptoms due to fluctuation in hormone levels. These symptoms can affect a woman's social and personal functioning and quality of life. The symptoms and quality of life experienced by women during menopause are closely related to health literacy and digital literacy levels.
Women in the menopausal period often turn to alternative and complementary practices to cope with the symptoms. They obtain this information from Web 2.0 technologies (Instagram, Facebook, etc.) and other sources on the internet, along with the innovations brought by the developing world. However, they do not have enough skills to question the reliability and accuracy of the information sources they obtain. In this context, digital literacy emerges as a new concept in today's digital transformation. Digital Literacy is the awareness, attitude and ability of individuals to use digital tools and possibilities appropriately to identify, access, manage, integrate, evaluate, analyze and synthesize digital resources, create new information, create media expressions and communicate with others. With the developing technology and widespread use of the internet, the impact of the information obtained from digital platforms on the current health literacy and quality of life of women is gaining importance.
Read more
In the literature, it has been determined that the relationship between digital literacy, health literacy and quality of life has been examined in different samples such as the elderly and individuals with chronic diseases. However, no research has been found in the literature examining the effect of a planned digital literacy education specific to menopause on the health literacy and quality of life of postmenopausal women.
The age group in which the research is planned is a group that can use Web 2.0 technologies (Instagram, Facebook, etc.) and other sources on the internet, but we think that they have limited information about accessing information sources and examining the accuracy of the information they have obtained. In this context, we believe that a planned digital literacy education specific to menopause will increase the health literacy and quality of life of postmenopausal women.
Read the detailed description
Purpose of the Study: This study was planned as a randomized controlled experimental study to examine the effect of digital literacy education given to postmenopausal women on health literacy and quality of life.
Data Collection: The data will be collected by the researcher by face-to-face interview method in a total of 5 sessions, each session of 30 minutes.
Statistical Methods to be Used: SPSS program will be used in the analysis of the obtained data. The conformity of the data to the normal distribution will be examined by considering the Shapiro-Wilk test; Parametric methods will be used in the analysis of normally distributed variables, and non-parametric methods will be used in the analysis of non-normally distributed variables. Independent-Samples T test, Mann-Whitney U (Exact) test and T test for Dependent Groups, Wilcoxon test will be used in the comparison of 2 independent groups. PearsonCorrelation, Spearman'srho tests will be used to examine the correlations of the variables with each other. Comparison of categorical data will be tested with PearsonChi-Square and FisherExact tests.
- Conditions
- Postmenopausal Symptoms, Literacy, Quality of Life, Health Literacy, Digitalism
- Being tested
- digital literacy education specific to menopause
- Keywords
- Postmenopausal Symptoms, digital literacy, Quality of Life, Health Literacy, menopause
- Medical subject headings
- Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital literacy education specific to menopauseBehavioural
Education; It is planned as 5 sessions in the form of presentation, homework, scenario and sending reminder messages. The training is planned to last approximately 20 minutes with a power point presentation prepared by the trainer. The survey will be evaluated in the first session. Women will be told what digital literacy is, why it is important, how to verify information and resources, security of accounts, resources, money and devices, access to information, understanding and valuing information. A screening and access to information session will be held with a scenario prepared on menopausal symptoms, taking into account the variables of information and resource security, access to information, understanding and valuing information, with examples on the digital platform. The woman will be given a scenario homework on menopausal symptoms. Interim evaluation will be made in the fourth week of the training. The final evaluation will be made in the fifth session.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Digital literacy education specific to menopause will be given to this group. Receives: Behavioral: digital literacy education specific to menopause |
| Control Group | No intervention | no intervention will be applied to this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
digital literacy education increases the digital literacy level of women
Digital Literacy Scale: The Digital Literacy Scale (DFLS) developed by Ng (2012) consists of 17 items. The scale items are answered by the participants in a 5-point Likert structure as "5: Strongly agree, 4: Agree, 3: Undecided, 2: Disagree, 1: Strongly disagree". The lowest score that can be obtained for the whole scale is 17 and the highest score is 85. While interpreting the mean score of the scale; Score ranges were used between 1.00-1.80 very low, 1.81-2.60 low, 2.61-3.40 medium, 3.41-4.20 high, 4.21-5.00 very high. Low scores from the overall Digital Literacy scale indicate low Digital Literacy level, while higher scores indicate high digital literacy.
Measured: The change in the digital literacy scale score of the participants in 2 months was evaluated with the digital literacy scale. Participants were expected to have an increase in their scores during this time.
digital literacy education increases women's health literacy level
Health Literacy Scale: It is the scale of the 47-item HealthLiteracySurvey in Europe (HLS-EU) form developed by Sorensen (2012) and later simplified by working together again by Toçi, Bruzari and Sorensen. The Health Literacy scale consists of 25 items and four sub-dimensions. The lowest score for the whole scale is 25 and the highest score is 125. The items in the scale are answered by the participants in a 5-point Likert structure as "5: I have no difficulty, 4: I have little difficulty, 3: I have a little difficulty, 2: I have a lot of difficulty, 1: I am unable to do / I have no ability / impossible". Low scores indicate that the Health Literacy status is insufficient, problematic and weak, while high scores indicate that it is sufficient and very good. As the score obtained from the scale increases, the health literacy level of the individual increases.
Measured: The change in the health literacy scale score of the participants in 2 months was evaluated with the health literacy scale. Participants were expected to have an increase in their scores during this time.
digital literacy education improves women's menopause-specific quality of life
The Menopause-Specific Quality of Life Questionnaire (MENQOL) was developed by Hilditch et al. in 1996 in order to evaluate the quality of life of menopausal women. The scale consists of 29 Likert type questions and 4 sub-domains: vasomotor (questions 1-3), psychosocial (questions 4-10), physical (questions 11-26) and sexual (questions 27-29). The score for each question ranges from 1 to 8. In the scoring, 1 point indicates that the situation did not occur, 2 points indicate that the situation did occur, but it was not disturbing, and a score between 3-8 indicates the severity of the situation. High scores on the scale indicate low quality of life.
Measured: The change in the participants' menopausal symptoms and coping skills at 2 months was evaluated with The Menopause-Specific Quality of Life Questionnaire. Participants were expected to have an increase in their scores during this time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start15 Nov 2022
- Primary completion20 Mar 2023
- Study completion10 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal SymptomsStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Type of Study: This study is a randomized controlled trial. The pre-test-post-test will be carried out with a pattern.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selcan Bakır, Istanbul University - Cerrahpasa
- Investigators
- selcan bakır, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659693
- Sponsor's protocol ID
- E-74555795-050.01.04-519850
- Status last verified
- Mar 2024
- First submitted
- 30 Nov 2022
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The information obtained from this study will be used for research purposes and personal information will be kept confidential; however, the data may be used for publication purposes. 2 years after the completion of the study, the data will be destroyed by the destruction machine belonging to the institution and will be kept locked in a closed cabinet during this period.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Digital Literacy Education Given to Postmenopausal Women on Health Literacy and Quality of Life
- ClinicalTrials.gov ID
- NCT05659693
- Acronym / sponsor ID
- E-74555795-050.01.04-519850
- Conditions
- Postmenopausal Symptoms, Literacy, Quality of Life, Health Literacy, Digitalism
- Keywords
- Postmenopausal Symptoms, digital literacy, Quality of Life, Health Literacy, menopause
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 10 Mar 2024 (estimated)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During menopause, women may experience many conditions and symptoms due to fluctuation in hormone levels. These symptoms can affect a woman's social and personal functioning and quality of life. The symptoms and quality of life experienced by women during menopause are closely related to health literacy and digital literacy levels.
Women in the menopausal period often turn to alternative and complementary practices to cope with the symptoms. They obtain this information from Web 2.0 technologies (Instagram, Facebook, etc.) and other sources on the internet, along with the innovations brought by the developing world. However, they do not have enough skills to question the reliability and accuracy of the information sources they obtain. In this context, digital literacy emerges as a new concept in today's digital transformation. Digital Literacy is the awareness, attitude and ability of individuals to use digital tools and possibilities appropriately to identify, access, manage, integrate, evaluate, analyze and synthesize digital resources, create new information, create media expressions and communicate with others. With the developing technology and widespread use of the internet, the impact of the information obtained from digital platforms on the current health literacy and quality of life of women is gaining importance.
In the literature, it has been determined that the relationship between digital literacy, health literacy and quality of life has been examined in different samples such as the elderly and individuals with chronic diseases. However, no research has been found in the literature examining the effect of a planned digital literacy education specific to menopause on the health literacy and quality of life of postmenopausal women.
The age group in which the research is planned is a group that can use Web 2.0 technologies (Instagram, Facebook, etc.) and other sources on the internet, but we think that they have limited information about accessing information sources and examining the accuracy of the information they have obtained. In this context, we believe that a planned digital literacy education specific to menopause will increase the health literacy and quality of life of postmenopausal women.
Detailed description
Purpose of the Study: This study was planned as a randomized controlled experimental study to examine the effect of digital literacy education given to postmenopausal women on health literacy and quality of life.
Data Collection: The data will be collected by the researcher by face-to-face interview method in a total of 5 sessions, each session of 30 minutes.
Statistical Methods to be Used: SPSS program will be used in the analysis of the obtained data. The conformity of the data to the normal distribution will be examined by considering the Shapiro-Wilk test; Parametric methods will be used in the analysis of normally distributed variables, and non-parametric methods will be used in the analysis of non-normally distributed variables. Independent-Samples T test, Mann-Whitney U (Exact) test and T test for Dependent Groups, Wilcoxon test will be used in the comparison of 2 independent groups. PearsonCorrelation, Spearman'srho tests will be used to examine the correlations of the variables with each other. Comparison of categorical data will be tested with PearsonChi-Square and FisherExact tests.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Type of Study: This study is a randomized controlled trial. The pre-test-post-test will be carried out with a pattern.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: digital literacy education specific to menopauseDigital literacy education specific to menopause will be given to this group. |
| Control Group | No intervention | –no intervention will be applied to this group. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being between 45 - 65 years old,
- Being in the postmenopausal period
- Using a smart phone, tablet and/or computer
- Digital literacy level of 3.40 and below
Key exclusion criteria (3 listed)
- Having a diagnosed psychiatric disorder
- Having a diagnosed cancer disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digital literacy education specific to menopauseEducation; It is planned as 5 sessions in the form of presentation, homework, scenario and sending reminder messages. The training is planned to last approximately 20 minutes with a power point presentation prepared by the trainer. The survey will be evaluated in the first session. Women will be told what digital literacy is, why it is important, how to verify information and resources, security of accounts, resources, money and devices, access to information, understanding and valuing information. A screening and access to information session will be held with a scenario prepared on menopausal symptoms, taking into account the variables of information and resource security, access to information, understanding and valuing information, with examples on the digital platform. The woman will be given a scenario homework on menopausal symptoms. Interim evaluation will be made in the fourth week of the training. The final evaluation will be made in the fifth session. | Behavioural | Experimental Group |
Primary outcome
digital literacy education increases the digital literacy level of women
Time frame: The change in the digital literacy scale score of the participants in 2 months was evaluated with the digital literacy scale. Participants were expected to have an increase in their scores during this time.
Digital Literacy Scale: The Digital Literacy Scale (DFLS) developed by Ng (2012) consists of 17 items. The scale items are answered by the participants in a 5-point Likert structure as "5: Strongly agree, 4: Agree, 3: Undecided, 2: Disagree, 1: Strongly disagree". The lowest score that can be obtained for the whole scale is 17 and the highest score is 85. While interpreting the mean score of the scale; Score ranges were used between 1.00-1.80 very low, 1.81-2.60 low, 2.61-3.40 medium, 3.41-4.20 high, 4.21-5.00 very high. Low scores from the overall Digital Literacy scale indicate low Digital Literacy level, while higher scores indicate high digital literacy.
digital literacy education increases women's health literacy level
Time frame: The change in the health literacy scale score of the participants in 2 months was evaluated with the health literacy scale. Participants were expected to have an increase in their scores during this time.
Health Literacy Scale: It is the scale of the 47-item HealthLiteracySurvey in Europe (HLS-EU) form developed by Sorensen (2012) and later simplified by working together again by Toçi, Bruzari and Sorensen. The Health Literacy scale consists of 25 items and four sub-dimensions. The lowest score for the whole scale is 25 and the highest score is 125. The items in the scale are answered by the participants in a 5-point Likert structure as "5: I have no difficulty, 4: I have little difficulty, 3: I have a little difficulty, 2: I have a lot of difficulty, 1: I am unable to do / I have no ability / impossible". Low scores indicate that the Health Literacy status is insufficient, problematic and weak, while high scores indicate that it is sufficient and very good. As the score obtained from the scale increases, the health literacy level of the individual increases.
digital literacy education improves women's menopause-specific quality of life
Time frame: The change in the participants' menopausal symptoms and coping skills at 2 months was evaluated with The Menopause-Specific Quality of Life Questionnaire. Participants were expected to have an increase in their scores during this time.
The Menopause-Specific Quality of Life Questionnaire (MENQOL) was developed by Hilditch et al. in 1996 in order to evaluate the quality of life of menopausal women. The scale consists of 29 Likert type questions and 4 sub-domains: vasomotor (questions 1-3), psychosocial (questions 4-10), physical (questions 11-26) and sexual (questions 27-29). The score for each question ranges from 1 to 8. In the scoring, 1 point indicates that the situation did not occur, 2 points indicate that the situation did occur, but it was not disturbing, and a score between 3-8 indicates the severity of the situation. High scores on the scale indicate low quality of life.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No. The information obtained from this study will be used for research purposes and personal information will be kept confidential; however, the data may be used for publication purposes. 2 years after the completion of the study, the data will be destroyed by the destruction machine belonging to the institution and will be kept locked in a closed cabinet during this period.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
selcan bakır principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital literacy education specific to menopause in people with Postmenopausal Symptoms and Literacy, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Selcan Bakır (+905389586702, selcanbakir244@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
digital literacy education increases the digital literacy level of women (time frame: The change in the digital literacy scale score of the participants in 2 months was evaluated with the digital literacy scale. Participants were expected to have an increase in their scores during this time.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.