Cervical CancerNCT04756440
The Effect of the Program on the Awareness of Roma Women on Cervical Cancer
A study testing Education Program and Music Therapy in people with Cervical Cancer, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
This study, which is designed according to the experimental model with randomized pre-test and post-test control group, will be carried out with Roman women who apply to Yavuz Selim Family Health Center in Samsun province, Canik district, where Roma citizens are densely registered.The population of the study consists… Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Education Program and Music Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2020to 15 Mar 2022
- 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 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being romani
- Be woman
- Being married or living / living with a partner
- To be registered at Yavuz Selim Family Health Center
- 30 years of age or older (to accept as the starting age for scans)
- Being literate
Show all 11Show fewer
- Not being educated about cervical cancer
- Not having been screened for cervical cancer before
- Not being pregnant or postpartum three-month jobs
- Agree to participate in research
- No communication barriers
Who cannot join
- Having had problems with the cervix before
- Having a cervical cancer screening
- Having had a hysterectomy operation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yavuz Selim Family Health Center
Samsun, 55080
About this study
Official title: The Effect of Music Therapy and Planned Education Program on Roma Women's Awareness and Health Beliefs Regarding Cervical Cancer and Screening
This study, which is designed according to the experimental model with randomized pre-test and post-test control group, will be carried out with Roman women who apply to Yavuz Selim Family Health Center in Samsun province, Canik district, where Roma citizens are densely registered.The population of the study consists of Roma women aged 30-65 who are registered to Yavuz Selim Family Health Center in Canik district of Samsun province. The working group will be composed of 80 Roma women who meet the selection criteria. The turkey in cervical cancer screening taking rate is 50% and 17% to 5% error when Roman population was identified as sample size 62 with power 80%.Since the study will consist of experiment and control groups, each group will be determined as 31 people, and 9 backups will be taken, considering that there may be losses. As a result, the research will be conducted as 40 people in the experimental group and 40 people in the control group.A personal questionnaire prepared by the researcher in line with the literature, Cervical Cancer and Pap Smear Test Health Belief Model Scale will be applied to the Roma women who apply to Yavuz Selim Family Health Center and who have accepted to participate in the study by explaining the purpose of the research and those who accept to participate in the study. Roma women who are pre-tested will be randomly assigned to the sample pool to be divided into experimental and control groups. Roman women will be divided into experimental and control groups by Simple Random Method.A 4-week training program will be applied to the experimental group. Afterwards, 2 weeks of training will be done through music. At the end of the training, a focus group discussion will be held with the participants in the experimental group regarding their educational experiences, learning experiences for cervical cancer and screening and program outcomes.A personal questionnaire, Cervical Cancer and Pap Smear Test Health Belief Model Scale will be applied to the experimental and control groups as a final test.
Read the detailed description
In this study, it is aimed to present an innovative approach in ensuring the participation of Roma women in cervical cancer screenings. For this purpose, music therapy and planned education program will be implemented in order to influence the health beliefs of Roma women.Study design ans setting The research was conducted in a randomized controlled double-blind pretest-posttest controlor the control group. The randomized clinical trial was based on the guidelines proposed by the Consolidated standard of Reporting Trials- CONSORT 2010. The data of the study will be collected in Samsun / Canik District Yavuz Selim Family Health Center between January and June 2021.
A personal questionnaire prepared by the researcher in line with the literature, Cervical Cancer and Pap Smear Test Health Belief Model Scale will be applied to the Roma women who apply to Yavuz Selim Family Health Center and who have accepted to participate in the study by explaining the purpose of the research and those who accept to participate in the study. Pre-tests will be done to the experimental and control group in a training room in Yavuz Selim Family Health Center. Collection of data will take approximately 15-20 minutes. Roma women who are pre-tested will be randomly assigned to the sample pool to be divided into experimental and control groups. Roman women will be divided into experimental and control groups by Simple Random Method.
Data Collection Tools Personal questionnaire; This form was developed in line with the literature and consists of 18 questions to determine the introductory characteristics of the participants. Personal questionnaire includes age, marital status, educational status, income, employment status, social security, family history of cervical cancer, first sexual intercourse age, first birth age, number of births, use of oral contraceptives, gynecological problems, Training status for cervical cancer will be questioned before.
Cervical Cancer and Pap Smear Test Health Belief Model Scale: This scale developed by Champion for breast cancer and mammography; Adapted to Cervical Cancer and Pap Smear Test. The Turkish validity and reliability study was carried out by Güvenç, Akyüz and Açıkel in 2010. The scale consists of 35 items and five main dimensions: sensitivity (3 items), severity (7 items), Pap Smear benefit and motivation (8 items), health motivation (3 items), Pap Smear barriers (14 items). 5-point Likert-type scaling ranging from 1 to 5 in the evaluation of the scale - "strongly disagree" (1), "disagree" (2), "undecided" (3), "agree" (4), "totally agree" (5) - method was used. Each dimension of the scale is evaluated separately and cannot be combined into a single total score. For each individual, points are obtained as much as the number of subscales. The higher the scores, the higher the sensitivity, caring and motivation; It states that the perceived benefits are high for the perception of benefit and the obstacles for the perception of disability are perceived high. Subscales other than the perception of disability subscale are positively associated with Pap Smear screening behavior. The high disability perception score of the individual indicates that the barriers related to having the Pap Smear test are high.
As a result of the research, the data obtained from the personal information form and the cervical cancer and pap smear test health belief model scale will be evaluated in the SPSS package program and will be reported. Descriptive statistics, paired t test, mc nemar test and correlation analysis will be used to evaluate the data. The data recorded with a voice recorder in the focus group meeting will be done by the player. Content analysis will be used in the analysis of the data. Inductive analysis, that is, content analysis based on coding, will be used in content analysis. In this analysis, similar data will be classified under certain concepts and themes and will be interpreted in an understandable way.
Ethical aspects: Study approval was given by Ondokuz Mayıs University Clinical Research Ethics Committee. (Decision No: B.30.2.ODM.0.20.08 / 616-704). All participants were informed about tis study and obtained orat-written informed consents.
- Conditions
- Cervical Cancer
- Being tested
- Education Program and Music Therapy
- Keywords
- Roma women, music therapy, early screening, cancer, awareness, health belief model
- Medical subject headings
- Uterine Cervical Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education Program and Music TherapyBehavioural
After the intervention, it is expected that their awareness of Romana cervical cancer will increase, their perception of obstacle towards screening tests will decrease and they will be tested.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Intervention Group | Experimental | Firstly, Pre-tests were applied to the women in the experimental group. The 4-week training program created by taking into account the cultural characteristics of the Roma; It includes the Anatomy of Female Reproductive Organs, Anatomy of the Cervix, Cancer, Cervical Cancer, Early diagnosis and its importance, Pap smear test, HPV-DNA test, Cancer Early Diagnosis, Screening and Education Center. Afterwards, music therapy will be applied to the women in the experimental group with the song written and composed by the researchers who emphasized the importance of early diagnosis. At the end of the program, a focus group discussion will be held with the participants in the experimental group regarding their educational experiences, learning experiences for cervical cancer and screening, and program outcomes. Final tests will be made 3 months after the training ends. Receives: Behavioral: Education Program and Music Therapy |
| No Intervention: Control Group | No intervention | First, pre-tests will be applied to the women in the control group. Women in this group will not be intervened and post-tests will be made 3 months after the pre-test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical Cancer and Pap Smear Test Health Belief Model Scale: Scale
The scale consists of 35 items and 5 sub-dimensions. Its part of the scale is evaluated separately and cannot be combined into a single total score. Cervical cancer sensitivity sub-dimension consists of 3 items. Hearing score 3-15. The higher the scores, the higher their sensitivity. The benefit and motivation sub-dimension of the Pap smear consists of 8 items. Points 8-40 helpful. An increase in scores indicates an increase in perceptions of benefit and motivation. Cervical cancer health motivation sub-dimension consists of 3 items. Hearing score 3-15. An increase in scores indicates an increased motivation for health. Pap smear barriers sub-dimension consists of 14 items. Scoring 14-70 officer. It means that the higher the scores, the higher the obstacles are perceived. Cervical cancer care / severity sub-dimension consists of 7 items. Hearing score 7-35. Increasing scores indicate an increase in caring / seriousness perceptions.
Measured: 3 months
Focus Group Meeting
A focus group discussion will be held with the participants in the experimental group regarding their educational experiences, learning experiences for cervical cancer and screening, and program outcomes. This evaluation will be completed in 3 sessions, separately for each group.
Session titles;
- How did the training and consultancy provided contributed to your learning on the subject?
- How did the information you get with composed music help you learn the subject?
- What are the contributions of this training program to your life?
- How did your experience of music therapy and planned education program affect your awareness of cancer prevention?
- What and what kind of trainings would you like in future trainings?
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start15 Aug 2020
- Primary completion15 Feb 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Randomized controlled experimental design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilknur Aydin Avci, Ondokuz Mayıs University
- Investigators
- İlknur AYDIN AVCİ, Prof, Study director, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756440
- Sponsor's protocol ID
- B.30.2.ODM.0.20.08/616-704
- Status last verified
- Mar 2022
- First submitted
- 11 Feb 2021
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aydin M, Avci IA. The effect of the music-supported education program on the awareness and health beliefs of Roma women about cervical cancer and screening. BMC Public Health. 2025 Apr 25;25(1):1536. doi: 10.1186/s12889-025-21884-4.
PubMed 40281521
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Therapy and Planned Education Program on Roma Women's Awareness and Health Beliefs Regarding Cervical Cancer and Screening
- ClinicalTrials.gov ID
- NCT04756440
- Acronym / sponsor ID
- B.30.2.ODM.0.20.08/616-704
- Conditions
- Cervical Cancer
- Keywords
- Roma women, music therapy, early screening, cancer, awareness, health belief model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 16 Feb 2021 (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.
This study, which is designed according to the experimental model with randomized pre-test and post-test control group, will be carried out with Roman women who apply to Yavuz Selim Family Health Center in Samsun province, Canik district, where Roma citizens are densely registered.The population of the study consists of Roma women aged 30-65 who are registered to Yavuz Selim Family Health Center in Canik district of Samsun province. The working group will be composed of 80 Roma women who meet the selection criteria. The turkey in cervical cancer screening taking rate is 50% and 17% to 5% error when Roman population was identified as sample size 62 with power 80%.Since the study will consist of experiment and control groups, each group will be determined as 31 people, and 9 backups will be taken, considering that there may be losses. As a result, the research will be conducted as 40 people in the experimental group and 40 people in the control group.A personal questionnaire prepared by the researcher in line with the literature, Cervical Cancer and Pap Smear Test Health Belief Model Scale will be applied to the Roma women who apply to Yavuz Selim Family Health Center and who have accepted to participate in the study by explaining the purpose of the research and those who accept to participate in the study. Roma women who are pre-tested will be randomly assigned to the sample pool to be divided into experimental and control groups. Roman women will be divided into experimental and control groups by Simple Random Method.A 4-week training program will be applied to the experimental group. Afterwards, 2 weeks of training will be done through music. At the end of the training, a focus group discussion will be held with the participants in the experimental group regarding their educational experiences, learning experiences for cervical cancer and screening and program outcomes.A personal questionnaire, Cervical Cancer and Pap Smear Test Health Belief Model Scale will be applied to the experimental and control groups as a final test.
Detailed description
In this study, it is aimed to present an innovative approach in ensuring the participation of Roma women in cervical cancer screenings. For this purpose, music therapy and planned education program will be implemented in order to influence the health beliefs of Roma women.Study design ans setting The research was conducted in a randomized controlled double-blind pretest-posttest controlor the control group. The randomized clinical trial was based on the guidelines proposed by the Consolidated standard of Reporting Trials- CONSORT 2010. The data of the study will be collected in Samsun / Canik District Yavuz Selim Family Health Center between January and June 2021.
A personal questionnaire prepared by the researcher in line with the literature, Cervical Cancer and Pap Smear Test Health Belief Model Scale will be applied to the Roma women who apply to Yavuz Selim Family Health Center and who have accepted to participate in the study by explaining the purpose of the research and those who accept to participate in the study. Pre-tests will be done to the experimental and control group in a training room in Yavuz Selim Family Health Center. Collection of data will take approximately 15-20 minutes. Roma women who are pre-tested will be randomly assigned to the sample pool to be divided into experimental and control groups. Roman women will be divided into experimental and control groups by Simple Random Method.
Data Collection Tools Personal questionnaire; This form was developed in line with the literature and consists of 18 questions to determine the introductory characteristics of the participants. Personal questionnaire includes age, marital status, educational status, income, employment status, social security, family history of cervical cancer, first sexual intercourse age, first birth age, number of births, use of oral contraceptives, gynecological problems, Training status for cervical cancer will be questioned before.
Cervical Cancer and Pap Smear Test Health Belief Model Scale: This scale developed by Champion for breast cancer and mammography; Adapted to Cervical Cancer and Pap Smear Test. The Turkish validity and reliability study was carried out by Güvenç, Akyüz and Açıkel in 2010. The scale consists of 35 items and five main dimensions: sensitivity (3 items), severity (7 items), Pap Smear benefit and motivation (8 items), health motivation (3 items), Pap Smear barriers (14 items). 5-point Likert-type scaling ranging from 1 to 5 in the evaluation of the scale - "strongly disagree" (1), "disagree" (2), "undecided" (3), "agree" (4), "totally agree" (5) - method was used. Each dimension of the scale is evaluated separately and cannot be combined into a single total score. For each individual, points are obtained as much as the number of subscales. The higher the scores, the higher the sensitivity, caring and motivation; It states that the perceived benefits are high for the perception of benefit and the obstacles for the perception of disability are perceived high. Subscales other than the perception of disability subscale are positively associated with Pap Smear screening behavior. The high disability perception score of the individual indicates that the barriers related to having the Pap Smear test are high.
As a result of the research, the data obtained from the personal information form and the cervical cancer and pap smear test health belief model scale will be evaluated in the SPSS package program and will be reported. Descriptive statistics, paired t test, mc nemar test and correlation analysis will be used to evaluate the data. The data recorded with a voice recorder in the focus group meeting will be done by the player. Content analysis will be used in the analysis of the data. Inductive analysis, that is, content analysis based on coding, will be used in content analysis. In this analysis, similar data will be classified under certain concepts and themes and will be interpreted in an understandable way.
Ethical aspects: Study approval was given by Ondokuz Mayıs University Clinical Research Ethics Committee. (Decision No: B.30.2.ODM.0.20.08 / 616-704). All participants were informed about tis study and obtained orat-written informed consents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled experimental design
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention Group | Experimental | Behavioral: Education Program and Music TherapyFirstly, Pre-tests were applied to the women in the experimental group. The 4-week training program created by taking into account the cultural characteristics of the Roma; It includes the Anatomy of Female Reproductive Organs, Anatomy of the Cervix, Cancer, Cervical Cancer, Early diagnosis and its importance, Pap smear test, HPV-DNA test, Cancer Early Diagnosis, Screening and Education Center. Afterwards, music therapy will be applied to the women in the experimental group with the song written and composed by the researchers who emphasized the importance of early diagnosis. At the end of the program, a focus group discussion will be held with the participants in the experimental group regarding their educational experiences, learning experiences for cervical cancer and screening, and program outcomes. Final tests will be made 3 months after the training ends. |
| No Intervention: Control Group | No intervention | –First, pre-tests will be applied to the women in the control group. Women in this group will not be intervened and post-tests will be made 3 months after the pre-test. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Being romani
- Be woman
- Being married or living / living with a partner
- To be registered at Yavuz Selim Family Health Center
- 30 years of age or older (to accept as the starting age for scans)
Key exclusion criteria (3 listed)
- Having had problems with the cervix before
- Having a cervical cancer screening
- Having had a hysterectomy operation
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 |
|---|---|---|
| Education Program and Music TherapyAfter the intervention, it is expected that their awareness of Romana cervical cancer will increase, their perception of obstacle towards screening tests will decrease and they will be tested. | Behavioural | Experimental: Intervention Group |
Primary outcome
Cervical Cancer and Pap Smear Test Health Belief Model Scale: Scale
Time frame: 3 months
The scale consists of 35 items and 5 sub-dimensions. Its part of the scale is evaluated separately and cannot be combined into a single total score. Cervical cancer sensitivity sub-dimension consists of 3 items. Hearing score 3-15. The higher the scores, the higher their sensitivity. The benefit and motivation sub-dimension of the Pap smear consists of 8 items. Points 8-40 helpful. An increase in scores indicates an increase in perceptions of benefit and motivation. Cervical cancer health motivation sub-dimension consists of 3 items. Hearing score 3-15. An increase in scores indicates an increased motivation for health. Pap smear barriers sub-dimension consists of 14 items. Scoring 14-70 officer. It means that the higher the scores, the higher the obstacles are perceived. Cervical cancer care / severity sub-dimension consists of 7 items. Hearing score 7-35. Increasing scores indicate an increase in caring / seriousness perceptions.
Focus Group Meeting
Time frame: 3 months
A focus group discussion will be held with the participants in the experimental group regarding their educational experiences, learning experiences for cervical cancer and screening, and program outcomes. This evaluation will be completed in 3 sessions, separately for each group. Session titles; * How did the training and consultancy provided contributed to your learning on the subject? * How did the information you get with composed music help you learn the subject? * What are the contributions of this training program to your life? * How did your experience of music therapy and planned education program affect your awareness of cancer prevention? * What and what kind of trainings would you like in future trainings?
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Derived from this study: PubMed 40281521Aydin M, Avci IA. The effect of the music-supported education program on the awareness and health beliefs of Roma women about cervical cancer and screening. BMC Public Health. 2025 Apr 25;25(1):1536. doi: 10.1186/s12889-025-21884-4.
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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.
İlknur AYDIN AVCİ, Prof study director
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education Program and Music Therapy in people with Cervical Cancer, run by Ondokuz Mayıs University 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 11 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: finished, as of the sponsor's last update on 4 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical Cancer and Pap Smear Test Health Belief Model Scale: Scale (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04756440, which also lists 1 linked publication.
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 4 Apr 2022.