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Not yet recruiting NCT07622602

Impact of Topical Aromatherapy on Postoperative Quality of Recovery After Lung Resection

No phase Interventional Thoracic Surgical Procedures Postoperative Recovery Pain Complementary Therapies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: topical application of the "AromaQoR" formulation, topical application of sweet almond vegetable oil.
Who it may be relevant to
Registry conditions: Thoracic Surgical Procedures, Postoperative Recovery, Pain, Complementary Therapies. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other topical application of the "AromaQoR" formulation
    topical application of the "AromaQoR" formulation, containing lavender essential oil (Lavandula angustifolia) diluted to 5% in sweet almond vegetable oil around the operated area
  • Other topical application of sweet almond vegetable oil
    topical application of sweet almond oil around the operated area

Primary outcome measures

  • Change in the total QoR-15F [Time frame: day 2]
Secondary outcome measures (8)
  • Change in the total QoR-15F score (Recovery Quality) on postoperative Day 1 (evening) [Time frame: Day 1]
  • Change in the total QoR-15F score (Recovery Quality) on postoperative Day 3 (evening) [Time frame: Day 3]
  • Change in the total QoR-15F score 3 weeks after discharge (postoperative consultation) [Time frame: Week 3]
  • Change in pain score at Day 0 (= day of surgery) [Time frame: Day 0]
  • Change in pain score at from postoperative Day 1 to postoperative Day 3 (morning, evening, night) [Time frame: Day 3]
  • Change in pain score at 3 weeks after discharge (day of postoperative consultation). [Time frame: week 3]
  • Quantification of the consumption of Nefopam [Time frame: day 3]
  • Quantification of the consumption of morphine derivatives (prescribed as a second-line treatment if Nefopam is ineffective) [Time frame: day 3]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07622602 · RC31/25/0027 · 2025-A01016-43

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗