Evaluation of the Impact of Aromatherapy Applied to the Skin as a Complementary Treatment on the Quality of Recovery (QoR) Following Lung Resection
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 124
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 否
入选标准
- •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.
排除标准
- •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
- •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.
