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临床试验/NCT03076879
NCT03076879已完成不适用

The Effect of Nursing Interventions on Women's Cervical Cancer Risk for Beliefs / Attitudes and Attendance to Screening Programme; Study Protocol for a Randomized Controlled Trial

Selcuk University2 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2017年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
114
试验地点
2
主要终点
Pap Smear Management Related Evaluation Form

研究概览

简要总结

In order to evaluate the effectiveness of nursing interventions aimed at the early detection of cervical cancer, health belief and participation in the screening of women aged 40-55 at risk for the purpose of cervical cancer, One-way blind pre-test and post-test randomized controlled trial.

详细描述

Cervical cancer is the 4th most common cancer type in the world, among women, in all age groups. Cervical cancer is a high-risk disease, and every two minutes, a woman loses her life due to cervical cancer. In Turkey, among the most common cancers among all age groups among women, 9th is the 5th among the most common cancers in the 25-49 age group. Cervix cancer is a type of cancer that can be prevented and treated at an early stage. Because cervical cancer has a long preclinical period, it has an early diagnosis possibility. For this reason, cervical cancer is one of the cancers recommended by World Health Organization (WHO) screening programs. In countries where regular screenings have been conducted, death rates from cervical cancer have decreased. In developing countries, high incidence and mortality continue due to the inadequacy of screening programs.

The first step in the early diagnosis of cervical cancer is usually the result of an abnormal Pap smear test. The Pap smear test is an ideal cytologic screening test used for screening because it can identify early onset of a cellular change that may be a starting point for cervical cancer and is cost effective. The number of women who have had the Pap smear test, which is so important in early diagnosis, is not at a level all over the world and in our country. In developed countries, cervical cancer screening rates are over 60%, while in underdeveloped and developing countries this rate is below 20%. In our country, the rate of not having any pap smear test over the age of 15 years is 77.9%.

Studies have shown that when women with cervical cancer are diagnosed early, their life span is prolonged and their chances of survival increase. Early diagnosis of cervical cancer is a simple, feasible and economical method. Women's lack of knowledge, worries about negative test results, and their reasons for not having a Pap smear test are among the reasons. Along with being semi-empirical studies in our country, most are based solely on education and do not involve a risk group approach. In addition, there was no randomized controlled trial (RCT) with evidence in the definition of causal relationship in our country. For this reason, determining the factors affecting the early diagnosis behavior of women, planning and implementing nursing interventions for these factors will contribute to the improvement of early diagnosis behavior of women with cervical cancer. In this respect, health education for cervical cancer and early diagnosis to be made to women in the risk group will have made a unique contribution to RCT including motivational initiatives and home visits.

In order to evaluate the effectiveness of nursing interventions aimed at early detection of cervical cancer, health beliefs and participation in scans in women aged 40-55 years at risk for prognostic cervical cancer, One-way blind pre-test - final test was planned as RCT. In this context, women in the risk group of 40-55 years of age with cervical cancer in the project will constitute the universe of RCT. No pap smear test, no previous training for cervical cancer, no previous hysterectomy, no previous cancer diagnosis, no current or past sexual life and at least one of the identified risk factors Will have women involved. Women who are in the risk group for cervical cancer and meet the inclusion and exclusion criteria of the study will be randomly assigned to the experimental and control groups. In the experimental group, cervical cancer will constitute nursing initiatives for health education, home visits, problem-specific counseling and phone reminders for women at risk. Women in the experimental group will receive a 15-week follow-up. Two reminders will be used to increase motivation between home visits and trainings. The effectiveness of counseling and training programs will be assessed by means of data collection tools that will be used for pretest / posttest for women in the experimental and control groups and the data form prepared by the researcher in the light of the literature.

Depending on the project, women are expected to participate in the cervical cancer screening program. Home visits, trainings, counseling and reminders by phone will raise awareness levels of women at risk for cervical cancer as a result. As a result, increased participation of women in the risk group in screening programs will increase the probability of early diagnosis and reduce cervical cancer mortality, reduce the cost and improve the health of the community.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

Blindness in the study will be done by data collectors and statisticians. The data will be collected by the assistant investigator who does not know who is in the experiment and control group and the data will be recorded on the computer by the assistant investigator without specifying the experiment and control group. The experimental and control groups will be codified by the co-investigator. The analysis of the data encoded by the groups will be done by a statistical expert. Data collectors, statistical analyzes and report writing will be blinded.

入排标准

年龄范围
40 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Being literate
  • Have not received any training on cervical cancer before

排除标准

  • Being pregnant or postpartum quarterly
  • Have already been diagnosed with any cancer
  • Not having sexual experience
  • Having undergone hysterectomy operation

研究组 & 干预措施

Intervention group

Experimental

The selected ASM was associated with risk factors related to direct cervical cancer in Turkey (using age 5 or older oral contraceptives, having three or more children, initiating sexual intercourse 16 years or older, at least one parenthesized smear test between 40-55 years) And randomly assigned to the experimental group to promoting participation in cervical cancer screening

干预措施: Promoting participation in cervical cancer screening (Behavioral)

Control Group

No Intervention

The selected ASM is the most common and associated with direct cervical cancer-related risk factors in Turkey (using oral contraceptives for longer than five years, having three or more children, starting sexual intercourse at the age of 16 and before, Women who are randomly assigned to the control group of women who have at least one pap smear test between the ages of 40 and 55 and who have at least one pap smear test in the family (especially a mother and a sister)

结局指标

主要结局

Pap Smear Management Related Evaluation Form

时间窗: 14 weeks after group training

This form, prepared by the researcher, consists of four questions that question the participation status of the scan and which application is more effective. This form will only be applied in the final test.

次要结局

  • Healthy Lifestyle Behavior Scale (Health Responsibility)(Before work begins and 14 weeks after group training)
  • Cervix Cancer And Pap-Smear Test Health Belief Model Scale(Before work begins and 14 weeks after group training)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

BUSRA ALTINEL

Research Assistant

Selcuk University

研究点 (2)

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