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临床试验/NCT06572436
NCT06572436尚未招募不适用

Evaluation of The Effect of Multimedia Information on Anxiety, Pain, Stress And Fear Levels Before Amniocentesıs And Chorıon Villus Sampling: A Randomized Controlled Study

Akdeniz University0 个研究点目标入组 90 人开始时间: 2024年10月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
90
主要终点
Change of Fear Score

研究概览

简要总结

It is known that the anxiety levels of pregnant women are high before amniocentesis and chorionic villus sampling and it is often neglected. The aim of this study is to examine the effects of multimedia information given before invasive prenatal diagnostic tests such as amniocentesis and chorionic villus sampling on the anxiety, pain, stress and fear levels of pregnant women.

Pregnant women who are planned to undergo amniocentesis and chorionic villus sampling are included in this prospective randomized controlled study. 90 pregnant women are randomized into two groups as study (n=45) and control group (n=45). Pregnant women in the study group are educated with multimedia information before amniocentesis and chorionic villus sampling. Pregnant women in the control group are given brief verbal information about the procedure before amniocentesis and chorionic villus sampling. Anxiety, pain, stress and fear levels are assessed immediately before multimedia information and after amniocentesis and chorionic villus sampling.

详细描述

Prenatal invasive tests such as amniocentesis and chorionic villus sampling are performed to exclude or diagnose fetal chromosomal abnormalities. Most invasive diagnostic methods cause anxiety and fear in individuals, which can be a source of anxiety and depression in individuals. Although prenatal invasive tests are a simple and short procedure, they can result in serious discomfort and increased pain perception. Studies have determined that pregnant women have high anxiety levels before amniocentesis and chorionic villus sampling. Anxiety is the most common negative emotion associated with invasive procedures and is also a determinant of mood and pain sensation after the intervention. Concerns about pain and potential complications increase the anxiety experienced by pregnant women. There are very few studies addressing the psychological aspect associated with prenatal invasive tests. Studies have shown that women who are candidates for amniocentesis experience "state anxiety" and depressive symptoms.

Patient education reduces anxiety and worry. Various methods are used in patient education. Among these, verbal education, written material/brochures and multimedia-based education (videos, compact discs, digital versatile discs and the internet) are the most commonly used. The results regarding which method is more effective in patient education are unclear. Education given to pregnant women about the purposes, benefits, risks and limitations of amniocentesis can reduce anxiety and worry in pregnant women. Education increases pregnant women's awareness of the amniocentesis process and its results. Patients remember 20% of what is explained, 40% of what they read and 80% with multimedia education. Multimedia-based education has become more frequently used in patient education due to developments in the field of information technology. Multimedia education program is implemented through texts, shapes, sounds, animations and video clips to strengthen the learning activity of users. Multimedia not only increases the learning motivation of users, but also increases the learning activity. Multimedia education has no obstacles in terms of space or time. Therefore, if the equipment is ready, the user can directly access a specific topic in the program at any time and from anywhere.

It has been shown that a multimedia education program applied before radiologic imaging, endoscopy, colonoscopy, bronchoscopy, invasive cardiac approaches and arthroscopy does not cause cost loss and reduces patient anxiety. A multimedia education program applied before birth has been shown to increase pregnant women's knowledge and decision-making skills and reduce their anxiety. Multimedia education program before amniocentesis did not provide a significant reduction in the anxiety of pregnant women. In another study, a multimedia education program before amniocentesis; It has been shown to be an easy intervention that can be used to reduce the anxiety of pregnant women.

There are no sufficient studies investigating the effects of multimedia information given before amniocentesis on the anxiety levels of pregnant women. Furthermore, the effectiveness of multimedia information as an intervention to reduce anxiety before chorionic villus sampling has not been investigated. The aim of this study is to investigate the effects of a multimedia information video watched before invasive prenatal diagnostic tests such as amniocentesis and chorionic villus sampling on the anxiety, pain, stress and fear levels of pregnant women.

This prospective randomized controlled study is conducted on pregnant women who are scheduled to undergo amniocentesis and chorionic villus sampling by the responsible physician who applied to University Hospital Gynecology and Obstetrics Clinic, who did not have known cerebrovascular disease, who did not have morbid obesity or heart disease that would prevent the study, who did not have cognitive disorders that would prevent communication, who did not have a history of stroke or related effects, and who agreed to participate in the study. Pregnant women who had previously undergone amniocentesis and chorionic villus sampling and who did not agree to participate in the study are excluded from the study. Informed consent is obtained from the participants before amniocentesis and chorionic villus sampling procedures are performed. We used the CONSORT (Consolidated Standards of Reporting Trials) checklist while writing our report. The study is approved by the University Faculty of Medicine Clinical Research Ethics Committee.

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 (Participant)

入排标准

性别
Female
接受健康志愿者

入选标准

  • pregnant women;
  • who were scheduled to undergo amniocentesis and chorionic villus sampling by the responsible physician who applied to University Hospital Gynecology and Obstetrics Clinic,
  • who did not have known cerebrovascular disease
  • who did not have morbid obesity or heart disease that would prevent the study
  • who did not have cognitive disorders that would prevent communication
  • who did not have a history of stroke or related effects, and who agreed to participate in the study.

排除标准

  • Pregnant women who had previously undergone amniocentesis and chorionic villus sampling and who did not agree to participate in the study

结局指标

主要结局

Change of Fear Score

时间窗: Change from Baseline Fear Score through study completion, an average of 1 hour

The Visual Analog Scale (VAS) was used as a one-dimensional scale for fear assessment. VAS is a self-administered, one-dimensional measure of pain intensity widely used in various adult populations. The VAS is a 10 cm long line in which participants mark the point they believe best represents the severity of fear. Always "0" means no pain, while "10" means excruciating fear. When asked, patients touch a point corresponding to their degree of fear, and this mark indicates the degree of fear on the scale. Higher scores indicate greater fear severity. After being included in the study, the initial fear levels of the participants in both groups are assessed. After the amniocentesis and chorionic villus sampling procedures, the second fear levels of the participants in both groups are assessed.

Change of Anxiety Score

时间窗: Change from Baseline Anxiety Score through study completion, an average of 1 hour

State-Trait Anxiety Inventory-I and II (STAI-I-II) is used to measure temporary and permanent anxiety.. These scales are four-point Likert type consisting of 20 items. While the STAI-I describes an individual's feelings at a specific moment or under specific conditions, STAI-II describes how an individual feels regardless of the situation and conditions. The scale includes direct and indirect (reverse) statements. The total scores of the indirect (reverse) statements are subtracted from the total weighted scores obtained from the direct statements and a fixed value of 50 points is added for STAI-I and 35 points for STAI-II. After being included in the study, the initial anxiety levels of the participants in both groups are assessed. After the amniocentesis and chorionic villus sampling procedures, the second anxiety levels of the participants in both groups are assessed.

Change of Pain Score

时间窗: Change from Baseline Pain Score through study completion, an average of 1 hour

The Visual Analog Scale (VAS) was used as a one-dimensional scale for pain assessment. VAS is a self-administered, one-dimensional measure of pain intensity widely used in various adult populations. The VAS is a 10 cm long line in which participants mark the point they believe best represents the severity of pain. Always "0" means no pain, while "10" means excruciating pain. When asked, patients touch a point corresponding to their degree of pain, and this mark indicates the degree of pain on the scale. Higher scores indicate greater pain severity. After being included in the study, the initial pain levels of the participants in both groups are assessed. After the amniocentesis and chorionic villus sampling procedures, the second pain levels of the participants in both groups are assessed.

Change of Stress Score

时间窗: Change from Baseline Stress Score through study completion, an average of 1 hour

The Visual Analog Scale (VAS) was used as a one-dimensional scale for stress assessment. VAS is a self-administered, one-dimensional measure of stress intensity widely used in various adult populations. The VAS is a 10 cm long line in which participants mark the point they believe best represents the severity of stress. Always "0" means no pain, while "10" means excruciating stress. When asked, patients touch a point corresponding to their degree of stress, and this mark indicates the degree of stress on the scale. Higher scores indicate greater stress severity. After being included in the study, the initial stress levels of the participants in both groups are assessed. After the amniocentesis and chorionic villus sampling procedures, the second stress levels of the participants in both groups are assessed.

次要结局

  • Height in Meters(Initial assessment before amniocentesis and chorionic villus sampling .)
  • Weight in Kilograms(Initial assessment before amniocentesis and chorionic villus sampling .)
  • Body Mass Index (BMI) in kg/m^2(Initial assessment before amniocentesis and chorionic villus sampling .)

研究者

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

Neriman Temel Aksu

Principal Investigator

Akdeniz University

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