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

27. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

124

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: 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.
Andet: topical application of sweet almond vegetable oil
topical application of sweet almond oil around the operated area
Eksperimentel: 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.
Andet: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in the total QoR-15F
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in the total QoR-15F score (Recovery Quality) on postoperative Day 1 (evening)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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).
Tidsramme: 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
Tidsramme: 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)
Tidsramme: day 3
number of tablets consumed per day
day 3

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Toulouse

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2028

Studieafslutning (Anslået)

1. juni 2028

Datoer for studieregistrering

Først indsendt

19. maj 2026

Først indsendt, der opfyldte QC-kriterier

27. maj 2026

Først opslået (Faktiske)

3. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RC31/25/0027
  • 2025-A01016-43 (Anden identifikator: Numéro ID-RCB)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Smerte

Kliniske forsøg med topical application of sweet almond vegetable oil

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