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Education Program on Increasing Osteoporosis Awareness Given to Women Aged 18-49

Primary Purpose

Osteoporosis Risk

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Education Program to Raise Osteoporosis Awareness
Sponsored by
Ankara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis Risk focused on measuring Osteoporosis, Osteoporosis Health Belief, Awareness, Education Program, Women Health

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Be between the ages of 18-49, Volunteering to participate in the study, To be at least primary school graduate, Not being pregnant or breastfeeding Not having a condition that prevents him from exercising, Not having a diet that limits daily calcium needs, Not having a planned training on osteoporosis before, Not being diagnosed with osteoporosis or osteopenia, Not be in the menopausal period, Not having a chronic disease Not having a situation that prevents communication (vision, hearing impairment, etc.). Exclusion Criteria: Not participating in the entire training program, Failure to fill in all of the data collection tools during the research process.

Sites / Locations

  • Altındağ Municipality; Karapürçek 1, Mimar Başak Cengiz, Yıldıztepe, Beşikkaya Women's Culture and Education Centers

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

After giving the necessary information about the research to the participants and obtaining written consent, an introductory information form, Osteoporosis Awareness Scale and Osteoporosis Health Belief Scale will be administered by the researcher to the women in the intervention group who meet the inclusion criteria in order to collect pre-test data just before the training program (before my first session). Eight weeks after the pretest data are collected (four weeks after the last session of the education program), the Osteoporosis Awareness Scale and the Osteoporosis Health Belief Scale will be administered to collect the posttest data.

After the participants were given the necessary information about the study and written consents were obtained, the Introductory Information Form, Osteoporosis Awareness Scale and Osteoporosis Health Belief Scale will be applied to the women in the control group who met the inclusion criteria in order to collect the pre-test data. Eight weeks after the pre-test data were collected, the Osteoporosis Awareness Scale and Osteoporosis Health Belief Scale will be applied to collect the post-test data.

Outcomes

Primary Outcome Measures

Pre-test data: An introductory information form, Osteoporosis Awareness Scale and Osteoporosis Health Belief Scale
Osteoporosis Awareness Scale: There are 27 questions and five sub-dimensions in the scale. The items in the scale are in four-point Likert type and classified as "I don't know at all" = 1, "I know a little" = 2, "I know" = 3, "I know very well" = 4. There are no reverse items and cut-off points in the scale. The total score obtained from the scale is minimum=27 maximum=108. As the score obtained from the scale increases, the level of awareness towards osteoporosis increases (Aktürk et al., 2021). There are 42 questions and seven sub-dimensions in the scale. The items in the scale are five-point Likert type, and the answer "strongly disagree"=1, "disagree" =2, "undecided" =3, "agree"=4, and "strongly agree" is evaluated as 5 points.The lowest score that can be obtained from the scale is 42 and the highest score is 210. The high score of the scale directly affects the health protective and improving behaviors of the person (Kılıç and Erci, 2004).

Secondary Outcome Measures

Post-test data: Osteoporosis Awareness Scale and Osteoporosis Health Belief Scale
Osteoporosis Awareness Scale: There are 27 questions and five sub-dimensions in the scale. The items in the scale are in four-point Likert type and classified as "I don't know at all" = 1, "I know a little" = 2, "I know" = 3, "I know very well" = 4. There are no reverse items and cut-off points in the scale. The total score obtained from the scale is minimum=27 maximum=108. As the score obtained from the scale increases, the level of awareness towards osteoporosis increases (Aktürk et al., 2021). There are 42 questions and seven sub-dimensions in the scale. The items in the scale are five-point Likert type, and the answer "strongly disagree"=1, "disagree" =2, "undecided" =3, "agree"=4, and "strongly agree" is evaluated as 5 points.The lowest score that can be obtained from the scale is 42 and the highest score is 210. The high score of the scale directly affects the health protective and improving behaviors of the person (Kılıç and Erci, 2004).

Full Information

First Posted
May 11, 2023
Last Updated
May 20, 2023
Sponsor
Ankara University
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1. Study Identification

Unique Protocol Identification Number
NCT05881850
Brief Title
Education Program on Increasing Osteoporosis Awareness Given to Women Aged 18-49
Official Title
The Effect of the Education Program on Increasing Osteoporosis Awareness Given to Women Aged 18-49 on Osteoporosis Awareness and Osteoporosis Health Beliefs
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Summary Purpose: To examine the effect of the education program to increase osteoporosis awareness given to women aged 18-49. Method: The research is planned to be carried out in the Women's Culture and Education Centers of Ankara Altındağ Municipality. Altındağ Municipality has 24 Women's Culture and Education Centers in 24 different neighborhoods with a total of 60000 registered members (https://www.altindag.bel.tr/#!kadin_egitim_kultur_merkezleri). It is planned that the research will be conducted in the first three centers where the most members between the ages of 18-49 from 24 Women's Culture and Education Centers are registered. In case the sufficient number of samples required for the conduct of the research could not be reached, it was planned to include the fourth center where women between the ages of 18-49 registered the most. The number of women to be included in the sample of the study was determined as 60 women, 30 of which were in the control group. Intervention and control groups will be assigned to the groups by randomization method. The data collection tools to be used in the research are the Introductory Information Form, the Osteoporosis Health Belief Scale and the Osteoporosis Awareness Scale. In the implementation of the research, a one-to-one training program will be held to increase awareness of osteoporosis. It is planned that the one-to-one education program to increase awareness of osteoporosis will be held every 2 weeks in 3 sessions in total and each session will last approximately 40-50 minutes.
Detailed Description
Type of Research The research will be conducted as a randomized controlled experimental study in the pre-test-post-test order. Research hypotheses H11 : There is a difference between the osteoporosis awareness scores of the women who participated in the training program to increase the awareness of osteoporosis and the osteoporosis awareness scores of the women who did not participate in the training program. H01: There is no difference between the osteoporosis awareness scores of the women who participated in the training program to increase the awareness of osteoporosis and the osteoporosis awareness scores of the women who did not participate in the training program. H12: There is a difference between the osteoporosis health belief scores of women who participated in the training program to increase awareness of osteoporosis and the osteoporosis health belief scores of women who did not participate in the training program. H02: There is no difference between the osteoporosis health belief scores of the women who participated in the training program to raise awareness of osteoporosis and the osteoporosis health belief scores of the women who did not attend the training. Place of Research The research is planned to be carried out in the Women's Culture and Education Centers of Ankara Altındağ Municipality. Altındağ Municipality has 24 Women's Culture and Education Centers in 24 different neighborhoods with a total of 60000 registered members (https://www.altindag.bel.tr/#!kadin_egitim_kultur_merkezleri). It is planned that the research will be conducted in the first three centers where the most members between the ages of 18-49 from 24 Women's Culture and Education Centers are registered. In case the sufficient number of samples required for the conduct of the research could not be reached, it was planned to include the fourth center where women between the ages of 18-49 registered the most. Necessary permissions were obtained from the centers where the research would be conducted. The permission obtained was reported to the Ethics Committee. Population and Sample of the Research In this study, the G*Power-3.1.9.2 program was used to calculate the sample size. The sample size was calculated at a 95% confidence level based on the Osteoporosis Health Belief Scale scores as a result of the study conducted by Pınar and Pınar (2020). As a result of the analysis, α=0.05 level, standardized effect size was calculated as d=0.9530, and with a power of 0.95, a minimum of 60 women, 30 in the intervention group and 30 in the control group, were found. Considering the possibility of participants who did not want to continue with the research, the number of women to be included in the sample of the study was determined as 70, taking into account the dropout rate of a similar study (Eyimaya & Tezel, 2021). According to the results of the power analysis, intervention and control groups will be determined by randomization among women who meet the inclusion criteria and agree to participate in the study. The directors of the institutions in the centers where the research will be conducted will make an announcement about osteoporosis awareness training for women between the ages of 18-49, invite women and create a list of volunteers. The researcher will contact the volunteer women and identify the women who meet the criteria for inclusion in the research. Volunteer women who meet the research criteria will be informed about the research and their informed consent will be obtained. The list of volunteer women who meet the research criteria will be listed alphabetically. Afterwards, the women who will be included in the study will be randomly selected from the list. In order to ensure randomization, random sample sequence numbers will be assigned from the randomized.org website. Data Collection Tools Introductory Information Form Osteoporosis Awareness Scale Osteoporosis Health Belief Scale Introductory Information Form In order to determine the introductory characteristics of the participants (age, educational status, etc.), a form was prepared by the researcher using the literature. The form was presented to the opinion of 6 different experts who are faculty members in the fields of Gynecology and Obstetrics Nursing, Midwifery, Nutrition and Dietetics, Physiotherapy and Rehabilitation and was arranged according to their suggestions. Osteoporosis Awareness Scale The Osteoporosis Awareness Scale was developed by Choi et al. (2008). In the original version of the scale, there are 31 questions and sub-dimensions of "protective behaviors", "risk factors", "characteristics of osteoporosis", "bone physiology" and "improving bone health" (Choi et al., 2008). Turkish validity and reliability studies of the scale were performed by Aktürk et al. (2021). In the Turkish version of the scale, the "improving bone health" sub-dimension in the original scale was not included, but the "exercise" sub-dimension was included. However, the number of questions has been reduced to 27. The sub-dimensions in the Turkish form of the scale are; "protective behaviors", "risk factors", "characteristics of osteoporosis", "exercise" and "bone physiology" (Aktürk et al., 2021). Cronbach's alpha value of the scale was 0.948 and sub-dimension Cronbach's alpha values; 0.917 for "protective behaviors", 0.820 for "risk factors", 0.839 for "osteoporosis features", 0.821 for "bone physiology" and 0.804 for "bone health promotion" (Choi et al., 2008). In the adaptation study of the scale to Turkish society, Cronbach's alpha value was 0.949 and sub-dimension Cronbach's alpha values; It was found to be 0.86 for "protective behaviors", 0.866 for "bone physiology", 0.882 for "risk factors", 0.866 for "exercise" and 0.858 for "characteristics of osteoporosis" (Aktürk et al., 2021). Osteoporosis Health Belief Scale The Osteoporosis Health Belief Scale was developed by Kim et al. (1991) to measure health beliefs about osteoporosis based on the Health Belief Model. The Turkish validity and reliability analyzes of the scale were performed by Kılıç and Erci (2004). There are 42 questions and seven sub-dimensions in the scale. The sub-dimensions of the scale are "perception of sensitivity", "perception of seriousness", "benefits of exercise", "benefits of taking calcium", "barriers to exercise", "obstacles of calcium intake" and "health motivation" (Kılıç & Erci, 2004). The Cronbach's alpha value of the scale is between 0.71-0.82 (Kim et al., 1991). The Cronbach alpha value of the scale, which was adapted into Turkish, is between 0.79-0.94 (Kılıç & Erci, 2004). Education Program to Raise Osteoporosis Awareness The education program will be prepared and implemented using the relevant literature. The content of the prepared education program was presented to the opinion of 6 experts in the field and arranged according to their suggestions. Due to the pandemic conditions, the education program prepared to increase awareness of osteoporosis will be conducted in a one-to-one education for each woman instead of group education. It is planned that the education program will consist of 3 sessions in total, to be held every 2 weeks, and each session will last approximately 40-50 minutes. In the realization of the education program, the education booklet prepared for osteoporosis awareness will also be used. The education program is planned to be given in the relevant centers where women are present. Before starting the research, it is planned to carry out a preliminary application of the education program with 3 women who meet the criteria for inclusion in the sampling in a Women's Culture and Education Center, where research data will not be collected under Altındağ Municipality. Contents of the Education Booklet A education booklet will be used in the education to be given during the implementation of the education program to increase awareness of osteoporosis. The education booklet was created in line with the relevant literature. It was sent to a total of 6 experts who are faculty members of the field of Gynecology and Obstetrics Nursing, Midwifery, Nutrition and Dietetics, Physiotherapy and Rehabilitation for evaluation. The education booklet presented to the expert opinions was also evaluated according to the DISCERN measurement tool. In our study, after the evaluation of the education booklet, the DISCERN score average was calculated as 72.5. The readability coefficient of the education booklet was calculated according to Ateşman's (1997) formula. According to the calculations made, the readability coefficient of the education Manual for Raising Osteoporosis Awareness for Women aged 18-49 was calculated as 67.7. It indicates that the readability level of this booklet is medium difficulty. Data Collection Collection of intervention group data After giving the necessary information about the research to the participants and obtaining written permissions, an introductory information form, Osteoporosis Awareness Scale and Osteoporosis Health Belief Scale will be applied by the researcher to the women in the intervention group who meet the inclusion criteria, just before the education program (before first session) in order to collect the pre-test data. Eight weeks after the pre-test data were collected, the Osteoporosis Awareness Scale and Osteoporosis Health Belief Scale will be applied to collect the post-test data. In the awareness studies in the literature, studies measuring post-test data 15 days after the intervention or at wider time intervals were found (Alnuaimi et al., 2021; Erenoğlu and Yaman Sözbir, 2020; Darawad et al., 2022). In this study, a study measuring one month later was taken as reference (Darawad et al., 2022). Collection of control group data After the participants were given the necessary information about the study and written consents were obtained, the Introductory Information Form, Osteoporosis Awareness Scale and Osteoporosis Health Belief Scale will be applied to the women in the control group who met the inclusion criteria in order to collect the pre-test data. Eight weeks after the pre-test data were collected, the Osteoporosis Awareness Scale and Osteoporosis Health Belief Scale will be applied to collect the post-test data. Variables of the Study Dependent variable: Osteoporosis awareness and Osteoporosis health belief. Independent variable: Education program to raise awareness of osteoporosis. Analysis of Data SPSS (Statistical Package for Social Sciences) program will be used to evaluate the data obtained from the research. In the analysis of continuous variables obtained from the measurements, mean and standard deviation, median (min-max), frequency and percentage values will be used in the analysis of categorical variables. It will be evaluated whether the continuous variables comply with the normal distribution by analyzing whether they comply with the parametric test conditions. The average score will be taken in the evaluation of the scales. In order to compare the research groups, Student's t test will be used in cases where normal distribution is provided, and Mann-Whitney U test will be used in cases where normal distribution is not provided. In the analysis of the difference between the pre-test and post-test scores of the participants, appropriate tests will be performed after determining whether the data are suitable for normal distribution. Cronbach's alpha reliability coefficient will be calculated in the internal consistency analyzes of the scales and the reliability of their sub-dimensions. In all statistical analyzes, p values less than 0.05 will be considered statistically significant. Ethical Principles Permission was obtained from the Ankara University Ethics Committee to conduct the study. The necessary permissions from the centers where the research will be conducted were obtained within the scope of the cooperation protocol between Ankara University Nursing Faculty and Altındağ Municipality. The permission obtained was reported to the Ethics Committee. In order to use the scales to be used in the research, permission was obtained from the authors via e-mail. Participants included in the study will be informed about the research through the Informed Voluntary Consent Form, and will be included in the study after their written consents are obtained. After the education program given to the women in the intervention group is over, the women in the control group and all the women who volunteered to participate in the research but were not in the control or intervention groups will be given a education and a education booklet, consisting of one session, in three groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis Risk
Keywords
Osteoporosis, Osteoporosis Health Belief, Awareness, Education Program, Women Health

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The research will be conducted in a pre-test-post-test order, as a randomized controlled experimental.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
After giving the necessary information about the research to the participants and obtaining written consent, an introductory information form, Osteoporosis Awareness Scale and Osteoporosis Health Belief Scale will be administered by the researcher to the women in the intervention group who meet the inclusion criteria in order to collect pre-test data just before the training program (before my first session). Eight weeks after the pretest data are collected (four weeks after the last session of the education program), the Osteoporosis Awareness Scale and the Osteoporosis Health Belief Scale will be administered to collect the posttest data.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
After the participants were given the necessary information about the study and written consents were obtained, the Introductory Information Form, Osteoporosis Awareness Scale and Osteoporosis Health Belief Scale will be applied to the women in the control group who met the inclusion criteria in order to collect the pre-test data. Eight weeks after the pre-test data were collected, the Osteoporosis Awareness Scale and Osteoporosis Health Belief Scale will be applied to collect the post-test data.
Intervention Type
Other
Intervention Name(s)
Education Program to Raise Osteoporosis Awareness
Intervention Description
Education program prepared to increase awareness of osteoporosis will be conducted in a one-to-one education for each woman instead of group training. It is planned that the training program will consist of 3 sessions in total, to be held every 2 weeks, and each session will last approximately 40-50 minutes. In the realization of the education program, the education booklet prepared for osteoporosis awareness will also be used.
Primary Outcome Measure Information:
Title
Pre-test data: An introductory information form, Osteoporosis Awareness Scale and Osteoporosis Health Belief Scale
Description
Osteoporosis Awareness Scale: There are 27 questions and five sub-dimensions in the scale. The items in the scale are in four-point Likert type and classified as "I don't know at all" = 1, "I know a little" = 2, "I know" = 3, "I know very well" = 4. There are no reverse items and cut-off points in the scale. The total score obtained from the scale is minimum=27 maximum=108. As the score obtained from the scale increases, the level of awareness towards osteoporosis increases (Aktürk et al., 2021). There are 42 questions and seven sub-dimensions in the scale. The items in the scale are five-point Likert type, and the answer "strongly disagree"=1, "disagree" =2, "undecided" =3, "agree"=4, and "strongly agree" is evaluated as 5 points.The lowest score that can be obtained from the scale is 42 and the highest score is 210. The high score of the scale directly affects the health protective and improving behaviors of the person (Kılıç and Erci, 2004).
Time Frame
just before the education program (before first session)
Secondary Outcome Measure Information:
Title
Post-test data: Osteoporosis Awareness Scale and Osteoporosis Health Belief Scale
Description
Osteoporosis Awareness Scale: There are 27 questions and five sub-dimensions in the scale. The items in the scale are in four-point Likert type and classified as "I don't know at all" = 1, "I know a little" = 2, "I know" = 3, "I know very well" = 4. There are no reverse items and cut-off points in the scale. The total score obtained from the scale is minimum=27 maximum=108. As the score obtained from the scale increases, the level of awareness towards osteoporosis increases (Aktürk et al., 2021). There are 42 questions and seven sub-dimensions in the scale. The items in the scale are five-point Likert type, and the answer "strongly disagree"=1, "disagree" =2, "undecided" =3, "agree"=4, and "strongly agree" is evaluated as 5 points.The lowest score that can be obtained from the scale is 42 and the highest score is 210. The high score of the scale directly affects the health protective and improving behaviors of the person (Kılıç and Erci, 2004).
Time Frame
Eight weeks after the pre-test data were collected

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Be between the ages of 18-49, Volunteering to participate in the study, To be at least primary school graduate, Not being pregnant or breastfeeding Not having a condition that prevents him from exercising, Not having a diet that limits daily calcium needs, Not having a planned training on osteoporosis before, Not being diagnosed with osteoporosis or osteopenia, Not be in the menopausal period, Not having a chronic disease Not having a situation that prevents communication (vision, hearing impairment, etc.). Exclusion Criteria: Not participating in the entire training program, Failure to fill in all of the data collection tools during the research process.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Funda Ozturk, Assos. Prof.
Organizational Affiliation
Ankara University
Official's Role
Study Director
Facility Information:
Facility Name
Altındağ Municipality; Karapürçek 1, Mimar Başak Cengiz, Yıldıztepe, Beşikkaya Women's Culture and Education Centers
City
Ankara
ZIP/Postal Code
6050
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33764278
Citation
Eyimaya AO, Tezel A. The effect of nursing approaches applied according to Meleis' Transition Theory on menopause-specific quality of life. Health Care Women Int. 2021 Jan;42(1):107-126. doi: 10.1080/07399332.2020.1825440.
Results Reference
result
PubMed Identifier
19122483
Citation
Choi E, Kim J, Chung M, Hwang K. [Development of an osteoporosis awareness scale for women]. J Korean Acad Nurs. 2008 Dec;38(6):813-21. doi: 10.4040/jkan.2008.38.6.813. Korean.
Results Reference
result
PubMed Identifier
2047537
Citation
Kim KK, Horan ML, Gendler P, Patel MK. Development and evaluation of the Osteoporosis Health Belief Scale. Res Nurs Health. 1991 Apr;14(2):155-63. doi: 10.1002/nur.4770140210.
Results Reference
result
PubMed Identifier
32964458
Citation
Alnuaimi K, Abuidhail J, Abuzaid H. The effects of an educational programme about preeclampsia on women's awareness: a randomised control trial. Int Nurs Rev. 2020 Dec;67(4):501-511. doi: 10.1111/inr.12626. Epub 2020 Sep 22.
Results Reference
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PubMed Identifier
35427994
Citation
Darawad MW, Shawashi TO, Al Duraidi H, Nofal B. Osteoporosis education: Evaluation of an awareness program among female university students. Int J Orthop Trauma Nurs. 2022 May;45:100926. doi: 10.1016/j.ijotn.2022.100926. Epub 2022 Feb 11.
Results Reference
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PubMed Identifier
31414370
Citation
Erenoglu R, Yaman Sozbir S. The Effect of Health Education Given to Syrian Refugee Women in Their Own Language on Awareness of Breast and Cervical Cancer, in Turkey: a Randomized Controlled Trial. J Cancer Educ. 2020 Apr;35(2):241-247. doi: 10.1007/s13187-019-01604-4. Erratum In: J Cancer Educ. 2020 Jan 30;:
Results Reference
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Citation
Pınar G, Pınar T. The Impact of health belief model based educational ıntervention on women's knowledge, beliefs, preventive behaviors and clinical outcomes about osteoporosis. SAGE Open. 2020; 10(3), 2158244020941473.
Results Reference
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Citation
Akürk SO, Meseri R, & Özentürk, MG. The psychometric property evaluation of the turkish version of the osteoporosis awareness scale. Turkish Journal of Osteoporosis/Turk Osteoporoz Dergisi. 2021; 27(3), 151-158.
Results Reference
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Citation
ATEŞMAN, E. Türkçe'de okunabilirliğin ölçülmesi. A.Ü. Tömer Dil Dergisi. 1997; 58: 71-74
Results Reference
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Citation
Kılıç D, Erci B. Osteoporoz sağlık inanç ölçeği, osteoporoz öz-etkililik/yeterlik ölçeği ve osteoporoz bilgi testi'nin geçerlilik ve güvenirliği. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi. 2004; 7(2); 89-102.
Results Reference
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Citation
Gökdoğan F."Etkili bir hasta iletişimi için araç geliştirme: yazılı materyallerin uygunluğunun Değerlendirilmesi (DISCERN). Onkoloji Hemşireliği Derneği Bülteni.2003; 16-17: 8-16
Results Reference
result

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Education Program on Increasing Osteoporosis Awareness Given to Women Aged 18-49

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