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临床试验/NCT06294769
NCT06294769已完成不适用

Effect of Aromatherapy on Postoperative Pain in Adult Patients in Post-anesthesics Recovering Room: Randomized Clinical Trial

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2024年3月18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
入组人数
138
试验地点
1
主要终点
Acute pain

研究概览

简要总结

Introduction: Pain is one of the main complications in the immediate postoperative period that can harm the patient and can be managed through pharmacological and non-pharmacological methods. Complementary Integrative Health Practices are non-pharmacological methods that use therapeutic resources based on traditional knowledge to treat symptoms. Among them, aromatherapy stands out, which consists of the use of essential oils through inhalation or topical application for therapeutic purposes and which can be used as a nursing intervention, especially in the context of perioperative care. Objective: To evaluate the effect of aromatherapy on postoperative pain in adult patients in the immediate postoperative period. Method: This is a randomized controlled clinical trial that will be carried out in a teaching hospital. The project was submitted to the Research Ethics Committees of the School of Nursing of the University of Sao Paulo and the University of Sao Paulo Hospital. Adult patients undergoing elective surgical procedures of any surgical specialty under anesthesia of any type will be included. Individuals diagnosed with dementia, cognitive impairment or chronic pain will be excluded; individuals with a history of asthma, allergic bronchitis, chronic obstructive pulmonary disease, contact dermatitis or allergy to cosmetics with lavender fragrance, or hypersensitivity to the compounds used in the intervention; procedure for reoperation for any reason. The intervention will consist of the application of aromatherapy with 2% lavender essential oil through the skin and inhalation by a nurse, associated with usual care, in the immediate postoperative period; the placebo group will only receive the application of grape seed vegetable oil associated with usual care. A numerical verbal scale will be applied to assess pain and vital parameters will be measured upon patient admission, every fifteen minutes in the first hour and every thirty minutes in the second hour or after 15, 30, 45, 60 minutes, 1h30 minutes and 2 hours after applying the intervention, in the post-anesthesia recovery room. Possible associations between variables will be verified using Pearson's Chi-square or Fisher's exact tests. Comparison between means or medians will be made using the Student's t or Mann-Whitney tests, depending on the normality determined according to the Kolmogorov-Smirnov test. The significance level adopted will be 5%.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • adult patients undergoing elective surgical procedures of any surgical specialty under anesthesia of any type

排除标准

  • individuals diagnosed with dementia, cognitive impairment or chronic pain;
  • individuals with a history of asthma, allergic bronchitis, chronic obstructive pulmonary disease, contact dermatitis or allergy to cosmetics with lavender fragrance, or hypersensitivity to the compounds used in the intervention;
  • procedure for reoperation for any reason

研究组 & 干预措施

Group 1: 2% lavender essential oil.

Experimental

Group will receive application of aromatherapy with 2% lavender essential oil dermal and inhalation via by a nurse, associated with usual care, in the immediate postoperative period.

干预措施: essencial oil of lavandula angustifolia (Other)

Group 2: grape seed vegetable oil.

Placebo Comparator

Placebo group will only receive the application of grape seed vegetable oil associated with usual care in the post anesthetic recovery room.

干预措施: grape seed vegetable oil (Other)

结局指标

主要结局

Acute pain

时间窗: 2 hours

A numerical verbal scale (1 to 10) for assessing pain upon patient admission, after 15, 30, 45, 60 minutes, 1h30 minutes and 2 hours after application intervention, in the post-anesthesia recovery room.

次要结局

  • Blood pressure (both systolic and diastolic)(2 hours)
  • Respiratory frequency(2 hours)
  • Oxygen saturation(2 hours)
  • Temperature(2 hours)
  • Heart rate(2 hours)

研究者

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

Maria Fernanda de Oliveira Faria

Investigador Maria Fernanda

University of Sao Paulo

研究点 (1)

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