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临床试验/NCT06265207
NCT06265207已完成不适用

The Effect of Virtual Reality Applied to Women Before Mammography on Pain, Anxiety and Satisfaction Level: Single-Blind Randomized Controlled Study

Ardahan University2 个研究点 分布在 2 个国家目标入组 78 人开始时间: 2024年2月15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
78
试验地点
2
主要终点
Satisfaction Evaluation Scale

研究概览

简要总结

In this study, it is planned to determine the effect of virtual reality applied to women before mammography on pain, anxiety and satisfaction levels. For this purpose, individuals applying for breast cancer screening will first be randomly divided into experimental and control groups. Pain, anxiety and satisfaction level evaluation forms will be applied to the experimental group before the mammography procedure. A relaxing video will be watched with virtual reality glasses and the mammography will be performed. At the end of the mammography, the relevant forms will be applied to the individuals again. The control group will not be subjected to any additional application that will continue with the applied routine.

详细描述

Purpose and duration of the research: This research is to determine the effect of virtual reality applied to women before mammography on the pain, anxiety and satisfaction levels.

Materials and methods of the research: This research is planned to be carried out in a pre-test post-test single-blind randomized controlled experimental design.

Research Questions/Hypotheses:

Hypotheses of the Research H0: Virtual reality applied to women before mammography has no effect on pain, anxiety and satisfaction levels.

H1a: Virtual reality applied to women before mammography has an effect on pain. H1b: Virtual reality applied to women before mammography has an effect on anxiety.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Since the researcher will be conducting the research, blinding will not be possible, and separate consent forms were prepared for the experimental and control groups, without specifying which group they were in, and it was planned to blind the participants in this way. In addition, in order to prevent statistical bias, it is planned to prevent bias in data analysis by coding the data as first group and second group, rather than experimental and control group, when entering the data into SPSS, and by not giving information about which group is the experiment and which is the control group.

入排标准

年龄范围
18 Years 至 69 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Having applied for mammography for screening purposes,
  • having no communication problems,
  • being over 18 years of age,
  • not having a history of breast cancer
  • voluntarily agreeing to participate in the study

排除标准

  • Being screened for breast cancer
  • having vision or hearing problems
  • being under 18 years of age.

结局指标

主要结局

Satisfaction Evaluation Scale

时间窗: an average of 6 months after the completion of the initiative

It is a scale that individuals can easily understand and is easy to apply. It is a scale indicated by a horizontal or vertical line, ranging from 0 = not at all satisfied to 10 = quite satisfied. The evaluation is made based on the average value.

Visual Comparison Scale

时间窗: an average of 6 months after the completion of the initiative

It provides a simple assessment of pain. Pain is rated between mild pain = 0 and unbearable pain = 10. Pain intensity is categorized as 1-3 mild, 4-6 moderate and 7-10 severe.

State Anxiety Inventory

时间窗: an average of 6 months after the completion of the initiative

The scale measures trait and state anxiety. In this study, 20 items that evaluate state anxiety will be used to evaluate state anxiety. The scale is scored in a four-point Likert type, as "1 = not at all, 2 = a little, 3 = a lot and 4 = completely". The lowest score that can be obtained from the scale is 20, while the highest score is 80. A high score indicates high anxiety, while a low score indicates low anxiety level.

次要结局

未报告次要终点

研究者

发起方
Ardahan University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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