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临床试验/NCT07523230
NCT07523230已完成不适用

The Effect of Antiemetic Timing on Nausea Severity and Patient Comfort in the Emergency Department: A Multicenter Interventional Study

muzeyyen ataseven1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年2月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
Change in Nausea Severity

研究概览

简要总结

Nausea is a common symptom among patients presenting to the emergency department and can negatively affect patient comfort and clinical outcomes. The timing of antiemetic administration may play a critical role in symptom control; however, evidence regarding the optimal timing remains limited. This multicenter interventional study aims to evaluate the effect of early versus delayed antiemetic administration on nausea severity and patient comfort in adult emergency department patients. Participants will be assigned to receive antiemetic treatment either within the first 30 minutes after triage or after 30 minutes. Nausea severity will be assessed using a numeric rating scale, and patient comfort will be evaluated at predefined time points. The findings of this study are expected to contribute to improving symptom management and optimizing clinical practices in emergency care settings.

详细描述

Nausea is a frequently encountered symptom in emergency department (ED) patients and is associated with decreased patient comfort, prolonged ED stay, and reduced satisfaction with care. Timely management of nausea is essential for improving patient outcomes; however, there is limited evidence regarding the impact of antiemetic administration timing on symptom relief and patient comfort. This study is designed as a prospective, multicenter interventional study to evaluate the effect of antiemetic timing on nausea severity and patient comfort in adult ED patients.

Eligible participants will include adult patients presenting to the ED with nausea. Participants will be allocated into two groups based on the timing of antiemetic administration: early administration (within 30 minutes after triage) and delayed administration (after 30 minutes). Antiemetic agents will be administered according to standard clinical practice.

The primary outcome of the study is nausea severity, which will be measured using a validated numeric rating scale. Secondary outcomes include patient comfort levels and changes in nausea over time. Measurements will be obtained at baseline and at predefined time intervals following antiemetic administration.

This study aims to provide evidence on whether early administration of antiemetic therapy leads to improved symptom control and patient comfort compared to delayed administration. The results may inform clinical decision-making and contribute to the development of evidence-based protocols for nausea management in emergency settings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Outcome assessors were blinded to group allocation to reduce assessment bias. Participants and care providers were aware of the intervention due to the nature of the study, as antiemetic timing could not be concealed.

入排标准

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

入选标准

  • Age ≥18 years
  • Presentation to the emergency department with nausea (with or without vomiting)
  • Receiving antiemetic treatment
  • Ability to communicate
  • Ability to provide informed consent
  • Ability to undergo nausea assessment using a Numeric Rating Scale (NRS) at initial evaluation

排除标准

  • Altered level of consciousness (unconscious or confused)
  • Intubated patients
  • Severe psychiatric conditions (e.g., psychosis or delirium)
  • Patients in critical condition requiring immediate resuscitation
  • Hemodynamic instability
  • Inability to communicate (including language barrier or severe hearing/speech impairment preventing scale application)
  • Refusal to participate

研究组 & 干预措施

Early Antiemetic Group

Experimental

Participants receive routine antiemetic treatment within 30 minutes after triage (T0). Nausea severity is assessed using a Numeric Rating Scale (NRS, 0-10) at baseline (T0), 30 minutes (Tpost30), and 60 minutes (Tpost60). Comfort level is evaluated at baseline and 60 minutes using the General Comfort Questionnaire-Short Form.

干预措施: Antiemetic Timing (Behavioral)

Delayed Antiemetic Group

Experimental

Participants receive routine antiemetic treatment more than 30 minutes after triage (T0). Nausea severity is assessed using a Numeric Rating Scale (NRS, 0-10) at baseline (T0), 30 minutes (Tpost30), and 60 minutes (Tpost60). Comfort level is evaluated at baseline and 60 minutes using the General Comfort Questionnaire-Short Form.

干预措施: Antiemetic Timing (Behavioral)

结局指标

主要结局

Change in Nausea Severity

时间窗: Baseline (T0), 30 minutes (Tpost30), and 60 minutes (Tpost60)

Nausea severity will be assessed using a Numeric Rating Scale (NRS, 0-10). Measurements will be obtained at baseline (T0), 30 minutes (Tpost30), and 60 minutes (Tpost60). The primary outcome is the change in nausea severity over time between the early and delayed antiemetic groups.

次要结局

  • Comfort Level(Baseline (T0) and 60 minutes (Tpost60))

研究者

发起方
muzeyyen ataseven
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

muzeyyen ataseven

PhD, RN, Assistant Professor

Istanbul Medipol University Hospital

研究点 (1)

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