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

T

Toulouse University Hospital

Status

Not yet enrolling

Conditions

Postoperative Recovery
Thoracic Surgical Procedures
Aromatherapy
Complementary Therapies
Pain

Treatments

Other: topical application of the "AromaQoR" formulation
Other: topical application of sweet almond vegetable oil

Study type

Interventional

Funder types

Other

Identifiers

NCT07622602
RC31/25/0027
2025-A01016-43 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

124 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

124 participants in 2 patient groups, including a placebo group

PL =placebo
Placebo Comparator group
Description:
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.
Treatment:
Other: topical application of sweet almond vegetable oil
AT = aromatherapy
Experimental group
Description:
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.
Treatment:
Other: topical application of the "AromaQoR" formulation

Trial contacts and locations

0

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Central trial contact

claudia Lavedan

Data sourced from clinicaltrials.gov

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