Impact of Topical Aromatherapy on Postoperative Quality of Recovery After Lung Resection (AromaQoR)
Evaluation of the Impact of Aromatherapy Applied to the Skin as a Complementary Treatment on the Quality of Recovery (QoR) Following Lung Resection
研究概览
地位
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
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:claudia Lavedan
- 电话号码:+33 5 67 77 18 74
- 邮箱:lavedan.c@chu-toulouse.fr
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
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
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
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|
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.
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topical application of the "AromaQoR" formulation, containing lavender essential oil (Lavandula angustifolia) diluted to 5% in sweet almond vegetable oil around the operated area
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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
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Change in the total QoR-15F score (Recovery Quality) on postoperative D1 (evening) compared to the baseline value on Day-1
|
Day 1
|
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Change in the total QoR-15F score (Recovery Quality) on postoperative Day 3 (evening)
大体时间:Day 3
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Change in the total QoR-15F score (Recovery Quality) on postoperative Day 3 (evening) compared to the baseline value on Day-1
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Day 3
|
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Change in the total QoR-15F score 3 weeks after discharge (postoperative consultation)
大体时间:Week 3
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Change in the total QoR-15F score 3 weeks after discharge (postoperative consultation) compared to the baseline value on D-1
|
Week 3
|
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Change in pain score at Day 0 (= day of surgery)
大体时间:Day 0
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pain score measured by numerical scale (EN) at each measurement time point compared to Day-1
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Day 0
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Change in pain score at from postoperative Day 1 to postoperative Day 3 (morning, evening, night)
大体时间:Day 3
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pain score measured by numerical scale (EN) at each measurement time point compared to Day-1
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Day 3
|
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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
|
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Quantification of the consumption of Nefopam
大体时间:day 3
|
number of ampoules consumed per day.
|
day 3
|
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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
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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