NCT04756440

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
Last Updated

April 4, 2022

Status Verified

March 1, 2022

Enrollment Period

1.5 years

First QC Date

February 11, 2021

Last Update Submit

March 31, 2022

Conditions

Keywords

Roma womenmusic therapyearly screeningcancerawarenesshealth belief model

Outcome Measures

Primary Outcomes (2)

  • 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.

    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?

    3 months

Study Arms (2)

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.

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.

Interventions

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.

Experimental: Intervention Group

Eligibility Criteria

Age30 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsCervical cancer is one of the cancer types in women.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being romani
  • Be woman
  • Being married or living / living with a partner
  • To be registered at Yavuz Selim Family Health Center
  • years of age or older (to accept as the starting age for scans)
  • Being literate
  • 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

You may not qualify if:

  • Having had problems with the cervix before
  • Having a cervical cancer screening
  • Having had a hysterectomy operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yavuz Selim Family Health Center

Samsun, 55080, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Uterine Cervical NeoplasmsNeoplasms

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • İlknur AYDIN AVCİ, Prof

    Ondokuz Mayıs University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Randomized controlled experimental design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Nursing Department

Study Record Dates

First Submitted

February 11, 2021

First Posted

February 16, 2021

Study Start

August 15, 2020

Primary Completion

February 15, 2022

Study Completion

March 15, 2022

Last Updated

April 4, 2022

Record last verified: 2022-03

Locations