Effect of an Informative Video Upon Anxiety and Stress in Patients Requiring an Oral Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Anxiety level comparison biopsy with two preoperative information types
研究概览
简要总结
In clinical practice, patients scheduled for biopsy often suffer substantial stress before, during or after the procedure. In particular, most patients feel uncomfortable both with the procedure itself and with the idea of the results of the biopsy.
Providing adequate information is crucial, though there is no agreement as to which is the best way to present such information. Although verbal information provided by the professional is the most common scenario, the use of written information in the form of explanatory leaflets, as well as audio recordings or videos, has also been proposed The present study was carried out at the Dental School of Universidad de San Carlos (Guatemala) to evaluate the hypothesis that an audiovisual intervention providing information on oral biopsy is able to reduce patient anxiety and stress.
详细描述
A prospective, randomized clinical trial was carried out involving. A total of 120 patients were therefore finally randomized, following the Consort Statement guidelines, with the definition of two groups: a control group (n = 60) that received standard verbal information, and an experimental group (n = 60) that received information in the form of a video
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria were a patient age of over 18 years and the presence of an oral lesion/s requiring biopsy.
排除标准
- •Patients with decompensated systemic disorders, poor general condition, a history of psychiatric disease or psychoactive drug use were excluded, as were pregnant women and individuals failing to sign the informed consent document.
结局指标
主要结局
Anxiety level comparison biopsy with two preoperative information types
时间窗: 1 day of Final measure of the biopsy intervention
Modified Dental Anxiety Scale (MDAS) was used to assess anxiety levels. The Modified Dental Anxiety Scale (MDAS) consisted of 5 questions ranging from 5 (no anxiety) to 25 (highest anxiety level). Every patient was asked to mark his or her perceived dental anxiety level on the line.
次要结局
- Evaluate patient-reported pain levels(1 day of final measure of the biopsy intervention)
研究者
Pia Lopez Jornet
Investigador principal Head Oral Medicine
Universidad de Murcia