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临床试验/NCT05832983
NCT05832983已完成不适用

The Effect of Aromatherapy on Situational Anxiety in Adults Receiving Intra-Articular Injections in the Ambulatory Clinic Setting

NYU Langone Health2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年7月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Change in Pain Score

研究概览

简要总结

While intra-articular injections can alleviate pain in orthopedic patients, this can be an anxiety-provoking experience. Adult patients scheduled to receive an injection at the study location will be randomly assigned to one of three groups. The control group (C) will receive the current standard of nursing care. The first experimental group (A) will receive a guided meditation prior to receiving the injection. The second experimental group (B) will receive an Elequil Aromatab and the same guided meditation prior to receiving the injection.

详细描述

The objective of the study is to measure the difference in anxiety levels of adult orthopedic patients in need of intra-articular injections who receive a guided meditation only prior to their injection, compared to those who receive a guided meditation and an aromatherapy Elequil Aromatab prior to injection, as well as compared with those who receive the usual standard of care

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

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

  • Patient has an in-office appointment at the NYU Langone Ambulatory Care-23rd Street location with either the Ortho A & B (primarily those patients who may be seeking knee or hip replacement surgery), Hand, or Primary Sport clinics.
  • Patient has an order for an intra-articular injection (as determined by clinic MD) and has consented to receiving that treatment.
  • Patient is English speaking.

排除标准

  • Patient has a cognitive or physical disability that would interfere with their ability to complete the study's pre and post assessments with RN.
  • Patient is found on the pre-injection assessment form to have an intolerance or allergy to lavender, sandalwood, or strong scents in general.

结局指标

主要结局

Change in Pain Score

时间窗: 10-15 minutes prior to injection, 5 minutes post-injection (Day 1)

On a scale of 0 to 10 (0 = no pain, 10 = the worst pain imaginable), participants rank their pain prior to the injection and after the injection. The total score ranges from 0-10, with higher scores indicating greater pain. A decrease in score indicates pain decreased during the observational period.

Change in Short-Version Spielberger State-Trait Anxiety Inventory (SSTAI) Score

时间窗: 10-15 minutes prior to injection, 5 minutes post-injection (Day 1)

The Short-Version SSTAI is a 10-item self-assessment of anxiety, with 5 items assessing states of anxiety and 5 items assessing traits of anxiety. Each item is scored on a Likert scale ranging from 1 to 4, where (1 = not at all) and (4 = very much so). The total score is the sum of responses and ranges from 10-40; lower scores indicate lower levels of anxiety. A decrease in scores indicates anxiety decreased during the observational period.

Change in Blood Pressure

时间窗: 10-15 minutes prior to injection, 5 minutes post-injection (Day 1)

Participants will have their blood pressure (systolic/diastolic - mmHg) taken before and after the injection.

Change in Heart Rate

时间窗: 10-15 minutes prior to injection, 5 minutes post-injection (Day 1)

Participants will have their heart rate (beats per minute) measured before and after the injection.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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