Clinical trial NCT04756440: The Effect of the Program on the Awareness of Roma Women on Cervical Cancer
Official title: The Effect of Music Therapy and Planned Education Program on Roma Women's Awareness and Health Beliefs Regarding Cervical Cancer and Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Keywords: Roma women
music therapy
early screening
cancer
awareness
health belief model
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 80
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Randomized controlled experimental design
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Cervical Cancer and Pap Smear Test Health Belief Model Scale: Scale
timeFrame: 3 months
measure: Focus Group Meeting
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Yavuz Selim Family Health Center
Study officials:
affiliation: Ondokuz Mayıs University
name: İlknur AYDIN AVCİ, Prof
role: STUDY_DIRECTOR
References: