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Impact of Topical Aromatherapy on Postoperative Quality of Recovery After Lung Resection (AromaQoR)

2026年5月27日 更新者:University Hospital, Toulouse

Evaluation of the Impact of Aromatherapy Applied to the Skin as a Complementary Treatment on the Quality of Recovery (QoR) Following Lung Resection

The key to early surgery recovery lies in optimal and immediate control of postoperative pain. Despite standard pain management protocols, lung resection is often associated with acute, neuropathic, or chronic pain, compounded by the side effects of morphine-based treatments. In this context, aromatherapy can provide complementary support, both to alleviate pain and to improve the quality of recovery after surgery.

研究概览

详细说明

Lung cancer is the leading cause of cancer mortality in France. Lung resection is the standard treatment for early-stage or locally advanced non-small cell lung cancer, but it remains a very painful procedure with a high risk of complications and a morbidity rate of around 30%. Enhanced Recovery After Surgery (ERAS) protocols have reduced morbidity and mortality through standardized perioperative care. Early and optimal pain control is essential to promote rapid mobilization, limit complications, and prevent chronicity. Despite multimodal management, acute, neuropathic, and chronic pain remain common after lung resection and impair the quality of recovery.

Complementary approaches, such as aromatherapy, are increasingly used to support conventional treatments, sometimes reducing the use of morphine derivatives and their adverse effects. Lavender (Lavandula angustifolia) essential oil and its main components, linalool and linalyl acetate, whose antinociceptive, anti-inflammatory, and anxiolytic properties are well documented, is of particular interest. Our study will evaluate the effect of daily application of 5% lavender essential oil (AromaQoR) to the skin around the surgical wound for three days following surgery on improving the quality of recovery.

The surgeon preselects eligible patients and the coordinating nurse ("IDEC") presents the study to them during a preoperative interview. The day before surgery, the IDEC obtains consent, has the QoR-15F completed, and performs an AromaQoR skin test. On the morning of surgery, only patients without allergic reactions are included and then randomized into two groups: placebo (PL) or intervention (AT). From D0 to D2, the intervention (placebo or AromaQoR) is applied every evening, while the QoR-15F questionnaire is collected daily by a different team. Pain scores (EN, DN4) are measured regularly, with only those taken the following morning being recorded, and all rescue analgesics are recorded. A post-operative consultation is conducted three weeks after discharge, during which the IDEC measures the EN and DN4 and collects the QoR-15F questionnaire completed by the patient. This consultation marks the end of follow-up for the trial.

研究类型

介入性

注册 (估计的)

124

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Adults aged 18 years or older,
  • undergoing scheduled lung resection for diagnostic or therapeutic purposes
  • able to give free, informed, signed consent (no later than the day of inclusion and before any examination required by the research)
  • person affiliated with or beneficiary of a social security system.

Exclusion Criteria:

  • Patients with chronic pain prior to surgery
  • patients undergoing daily pain relief treatment prior to surgery
  • patients using essential oils applied to the skin for pain relief.
  • In relation to aromatherapy:
  • history of allergy to essential oils
  • atopic skin
  • known allergies
  • asthma
  • pregnant or breastfeeding women
  • nut allergies (in relation to sweet almond oil)
  • individuals who are vulnerable or deprived of their liberty by judicial or administrative decision
  • patients participating in other interventional studies on pain.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
安慰剂比较:PL =placebo
The PL group: In addition to standard pain relief treatments, the PL group will receive topical application of sweet almond oil around the operated area at 9 p.m. from day 0 to day 2.
topical application of sweet almond oil around the operated area
实验性的:AT = aromatherapy
The AT group: in addition to standard analgesic treatments, the AT group will receive topical application of the "AromaQoR" formulation, containing lavender essential oil (Lavandula angustifolia) diluted to 5% in sweet almond vegetable oil around the operated area at 9 p.m. from day 0 to day 2.
topical application of the "AromaQoR" formulation, containing lavender essential oil (Lavandula angustifolia) diluted to 5% in sweet almond vegetable oil around the operated area

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in the total QoR-15F
大体时间:day 2
Change in the total QoR-15F score (Recovery Quality score) on postoperative day 2 (measured in the evening, as it assesses, among other things, activity during the day) compared to the baseline value obtained the day before surgery, day -1, between the two groups.
day 2

次要结果测量

结果测量
措施说明
大体时间
Change in the total QoR-15F score (Recovery Quality) on postoperative Day 1 (evening)
大体时间:Day 1
Change in the total QoR-15F score (Recovery Quality) on postoperative D1 (evening) compared to the baseline value on Day-1
Day 1
Change in the total QoR-15F score (Recovery Quality) on postoperative Day 3 (evening)
大体时间:Day 3
Change in the total QoR-15F score (Recovery Quality) on postoperative Day 3 (evening) compared to the baseline value on Day-1
Day 3
Change in the total QoR-15F score 3 weeks after discharge (postoperative consultation)
大体时间:Week 3
Change in the total QoR-15F score 3 weeks after discharge (postoperative consultation) compared to the baseline value on D-1
Week 3
Change in pain score at Day 0 (= day of surgery)
大体时间:Day 0
pain score measured by numerical scale (EN) at each measurement time point compared to Day-1
Day 0
Change in pain score at from postoperative Day 1 to postoperative Day 3 (morning, evening, night)
大体时间:Day 3
pain score measured by numerical scale (EN) at each measurement time point compared to Day-1
Day 3
Change in pain score at 3 weeks after discharge (day of postoperative consultation).
大体时间:week 3
pain score measured by numerical scale (EN) at each measurement time point compared to Day-1
week 3
Quantification of the consumption of Nefopam
大体时间:day 3
number of ampoules consumed per day.
day 3
Quantification of the consumption of morphine derivatives (prescribed as a second-line treatment if Nefopam is ineffective)
大体时间:day 3
number of tablets consumed per day
day 3

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2028年6月1日

研究完成 (估计的)

2028年6月1日

研究注册日期

首次提交

2026年5月19日

首先提交符合 QC 标准的

2026年5月27日

首次发布 (实际的)

2026年6月3日

研究记录更新

最后更新发布 (实际的)

2026年6月3日

上次提交的符合 QC 标准的更新

2026年5月27日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • RC31/25/0027
  • 2025-A01016-43 (其他标识符:Numéro ID-RCB)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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