跳至主要内容
临床试验/NCT05656612
NCT05656612已完成不适用

The Effect of Education Given at Different Times Before a Breast Biopsy on Anxiety, Readiness for the Procedure, Satisfaction, and Pain Levels in Women: A Randomized Study

Saglik Bilimleri Universitesi2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
change anxiety level

研究概览

简要总结

Aim: This study was conducted to investigate the effect of education given at different times before a breast biopsy on anxiety, readiness for the procedure, pain, and satisfaction levels in women. Background: A breast biopsy is an invasive procedure that causes pain and anxiety. Patient education is an effective and evidence-based nursing intervention that reduces pain and anxiety levels. Design: The study is a single-center, uncontrolled randomized clinical trial. Method: Participants (n: 60) in the study were randomly assigned into three groups. The first group (n: 20) was given education about the breast biopsy 1-2 weeks before the procedure, the second group (n: 20) was given education on the day of the procedure, and the third group (n: 20) was given education at two different times, the first 1-2 weeks before the procedure and the second on the day of the procedure. Research data were collected by using a Descriptive Characteristics Form, the State Anxiety Inventory, and a Patient Assessment Form.

详细描述

INTRODUCTION Breast cancer has the highest incidence among women worldwide. Of the three methods (physical examination, imaging, and biopsy) in the diagnosis of breast lesions and breast cancer, the biopsy is a frequently used standard. A breast biopsy is a safe and effective diagnostic method, but it causes pain and anxiety, especially for those who will have a biopsy for the first time. Considering the clinically significant anxiety levels experienced by women before a biopsy, it is necessary to develop strategies to help them manage their anxiety better. Various studies have shown that uncertainty about the biopsy procedure is associated with high levels of anxiety, and women experience less anxiety and other negative emotions if they are given reassuring information about the procedure. However, no study has been found in the literature regarding the optimal time for patient education to be planned for a breast biopsy. There is a need to determine the most accurate time for patient education. Although there are many studies on education methods to reduce anxiety and other related problems before interventional procedures, the optimal time for this education is still being debated. It is considered that there is a need for research into determining the most effective education time for patient education to be given before a breast biopsy.

RESEARCH QUESTION AND OBJECTIVES Although the effectiveness of educational interventions in reducing the anxiety and pain levels of patients and increasing their readiness and satisfaction for the procedure before a breast biopsy has been shown, very little is known about the optimal time for this educational intervention. Knowledge of the optimal education time will both increase patient comfort in the best way and help us to manage the personnel workforce and cost in the best way. Therefore, this study was conducted to evaluate the effects of patient education given at different times before a breast biopsy on anxiety, readiness for the procedure, pain, and satisfaction levels in women.

Hypotheses of the Research:

H0: There is no difference between patients who receive education 1-2 weeks before a breast biopsy, patients who receive education on the day of the procedure, and patients who receive repetitive education at both times in terms of anxiety, readiness, pain, and satisfaction levels.

H1: There is a difference between patients who receive education 1-2 weeks before a breast biopsy, patients who receive education on the day of the procedure, and patients who receive repetitive education at both times in terms of anxiety, readiness, pain, and satisfaction levels.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • Women who were older than 18 years of age, had a breast biopsy for the first time, had no communication problems, and volunteered to participate in the study were included in the study.

排除标准

  • Women who had major hearing, vision, or speech impairments or those who used antidepressants or anxiolytic drugs were not included in the study.

结局指标

主要结局

change anxiety level

时间窗: It was evaluated on the day of breast biopsy.

State anxiety levels of patients

initial state anxiety level

时间窗: It was evaluated 1-2 weeks before the breast biopsy.

State anxiety levels of patients

initial readiness level

时间窗: It was evaluated 1-2 weeks before the day of breast biopsy.

Patients' level of readiness for the breast biopsy was evaluated with the visual analog scale.

Satisfaction level with the procedure

时间窗: It was evaluated once day of the procedure, after breast biopsy procedure.

Satisfaction with the breast biopsy was evaluated.with the visual analog scale.

Satisfaction level with the education

时间窗: It was evaluated once day of the procedure, after breast biopsy procedure.

Satisfaction with the education was evaluated with the visual analog scale.

change readiness level

时间窗: It was evaluated day of the procedure, just before the procedure.

patients' level of readiness for the procedure

pain level

时间窗: It was evaluated once day of the procedure, after the breast biopsy procedure.

Pain felt during the breast biopsy was evaluated with the visual analog scale.

次要结局

未报告次要终点

研究者

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

Cansu Cil

specialist nurse

Saglik Bilimleri Universitesi

研究点 (2)

Loading locations...

相似试验