Management of Meaningful Accompaniment as a Nursing Strategy to Reduce Patient Anxiety in Endoscopic Procedures in a Public Hospital, Year 2021: Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Decrease 5 points on the anxiety scale. The preferred format is to use outcome-neutral language in Outcome Measure Title and Description (e.g., "change" instead of "decrease"). Please review and revise as appropriate.
研究概览
简要总结
An upper digestive endoscopy diagnostic procedure is undoubtedly a situation that will generate anxiety. The environment, protocols, distance the patient from the family member or partner, which is perceived as a threat to integrity. The objective of the study is to determine the effectiveness of a structured, significant follow-up nursing intervention to reduce anxiety in patients who are going to undergo upper digestive endoscopy in a public hospital in the Biobío Region, year 2021. The methodological proposal will be in a randomized, single-blind, third-party evaluation clinical trial, the intervention will consist of the visual and tactile presence of a significant companion throughout the endoscopic procedure. The sample will be 126 that will make up the experimental and control group. It is hypothesized that patients who have a significant follow-up will obtain 10 points less on the anxiety scale compared to those who did not have the intervention. The data will be collected with the Spielberg state / anxiety test (STAIT) and the Visual Analog Scale (VAS) to measure psychological effects, with vital parameters (pressure, pulse, respiration, saturometry), physiological effects, as well as the effects biochemicals with blood levels of potassium, glycemia and cortisol in saliva and mechanical effects through the monitoring of movements, using a mesh of pressure sensors. The difference-in-difference statistical method will be applied by t student, to analyze the data. The requirements of Emmanuel will be applied to safeguard the ethics of the study. It is hoped that significant follow-up as a nursing intervention will be shown to reduce the anxiety of the patient who is going to undergo an endoscopic procedure.
详细描述
The study is a clinical trial, with random assignment to two groups: control and experimental, that is, the study corresponds to a Design with Pretest-Postest and Control Group. The sample will be made up of all the patients who will undergo an endoscopy procedure in a public hospital, during the first quarter of the year 2021 and the intervention will be the significant accompaniment that the patient who is going to undergo an endoscopic procedure of the group will have experimental (EG) in the pre-procedure stage - during the procedure and after the procedure, while the control group (CG) will receive the usual care of the service under study, that is, without a significant companion.
DESCRIPTION OF THE STAGES OF THE INTERVENTION
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- PRE PROCEDURE PERIOD
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Mediate: Due to the COVID-19 pandemic contingency, it is necessary to adopt the necessary security measures before, during and after conducting the interview with the patient who is going to undergo an endoscopic procedure. In this context, in the mediate preoperative period, to inform the patient that he is going to undergo an endoscopic procedure, non-face-to-face interviews will be promoted, through the use of electronic means, through videoconferencing, recorded telephone calls or emails, if the patient so requires, as well as conducting face-to-face interviews according to the protocols provided for it. The selected patients will be contacted by the coordinating nurse 3 or 4 days in advance, informing them that they must approach the emergency service to take PCR test (to detect COVID-19, this telephone contact will be the one that the responsible researcher will use to propose the voluntary participation in the study. If approved, the nursing professional responsible for the study will request the signing of the informed consent on the day the patient and companion attend to take the PCR test.
PROTOCOL SIGNATURE INFORMED CONSENT NOT PRESENTIAL
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age.
- •Patients who can read and write
- •Patient who is the first endoscopy to undergo
- •Patient who in previous hospitalizations have had no incidents.
- •Patient participating throughout the surgical stage with a significant companion.
- •Spanish speaking patients.
- •Patients living in the Bío-Bío Region.
- •Patients who have signed informed consent and agreed to participate voluntarily
排除标准
- •Patients older than 85 years.
- •Patients with psychiatric disorders.
- •Patients with severe sensory alterations or disabilities that make the interview difficult.
- •Patients with alterations or injuries in the hands that hinder sensitivity.
- •Patients with treatments with sedatives and / or NSAIDs, since their use could affect blood pressure.
结局指标
主要结局
Decrease 5 points on the anxiety scale. The preferred format is to use outcome-neutral language in Outcome Measure Title and Description (e.g., "change" instead of "decrease"). Please review and revise as appropriate.
时间窗: 60 minutes measured before and after endoscopic procedure
Patients who have a significant accompaniment structured follow-up have less 5 points on the anxiety scale compared to patients who did not have the intervention, with 0 points until 60 points and higher scores indicate a worse result.
次要结局
- Mantainance or not increase of Psychological parameters(30 minutes measured during the endoscopic procedure)
- Maintenance or not increase of Biochemical parameters(60 minutes measured two times (before and after endoscopic procedure))
- Maintenance or not increase of physiological parameters(60 minutes measured three times (before, during and after endoscopic procedure))
研究者
Patricia Jara Concha, Dr
Full Professor
Universidad de Concepcion