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临床试验/NCT06021496
NCT06021496已完成不适用

The Effect of Two Different Methods of Health Education on Women's HPV Knowledge, Cervical Cancer Health Belief and Screening

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2023年2月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
126
试验地点
1
主要终点
HPV Knowledge Scale

研究概览

简要总结

Aim: The aim of this study is to determine the effect of health education given by two different methods on women's knowledge about HPV, cervical cancer health belief and screening test.

Materials and Methods: The study was conducted in a parallel groups design as a single-blind randomized controlled trial. The sample consisted of 126 healthy participants, 42 in each volunteer group, who were registered at the Martyr Zafer Çalışkan Family Health Center in Ankara between January and July 2023, and met the inclusion criteria. HPV Knowledge scale, Cervical Cancer and pap Smear Test Health Belief Model Scale and VAS for self-assessment were used in the study. In the study, while the control group received standard care, the face-to-face education group was given health education and brochures through home visits and a reminder interview over the phone; On the other hand, the online training group was given health education and a digital brochure via video call and a reminder meeting was held once. One-way analysis of variance and Kruskal Wallis test were used to compare the data of the three groups after a two-month follow-up, Tukey and Dunn test for multiple comparisons, and Wilcoxon test for in-group comparisons before and after. In addition, two-way analysis of variance and Robust ANOVA were used in group and time comparisons.

详细描述

In this randomized controlled trial, participants were assigned to three groups by the block randomization method and the study was conducted in a single-blind parallel groups design. It was carried out at Martyr Zafer Çalışkan Family Health Center between January 2023 and July 2023. The eligibility of female participants between the ages of 30-65 to participate in the study was evaluated by the researcher. The sample size was calculated based on the rate of cervical cancer screening test in Kurt and Akyüz's study. G Power 3.1.9.2 package program was used in the calculation. Taking into account possible data loss, it was decided to add 30% backup participants. In this context, the sample of the study was calculated as 126 participants, 42 in each group. The patients who volunteered to participate in the study were examined whether they met the inclusion criteria other than the level of drug compliance. Written informed consent was obtained from the participants who met the inclusion criteria and a questionnaire form was applied. Participants were assigned to groups using the block randomization method. No intervention was made in the control group. At the end of the following first week, face-to-face and online training was provided with the participants in the online training group, one-to-one home visits, face-to-face training and video calls. Four weeks later, a brief reminder was made by phone call. At the end of eight weeks, a second questionnaire was applied to all groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

single blind study, participants do not know their group

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • The criteria for inclusion in this study are;
  • Volunteering to participate in the study,
  • To be between the ages of 30-65,
  • Being a woman
  • Being married/having an active sexual life,
  • Having the technical equipment to make video calls,
  • To be literate in Turkish,
  • Not having had an HPV DNA / Pap Smear test in the last 5 years. -

排除标准

  • The criteria for not being included in this study are;
  • Being pregnant or in the postpartum trimester,
  • Having a family history of cervical cancer,
  • Having had a hysterectomy operation,
  • To have received any previous training on cervical cancer,
  • Having a vaginal infection,
  • To be vaccinated against HPV (3 doses). -

结局指标

主要结局

HPV Knowledge Scale

时间窗: 60 days

HPV Knowledge Scale consists of 4 sub-dimensions and 33 items. Participants score between 0-33.

次要结局

  • Cervical Cancer and Pap Smear Test Health Belief Model Scale(60 days)

研究者

发起方
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Serpil Özdemir

Asisstant Professor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

研究点 (1)

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