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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: claudia Lavedan
- 전화번호: +33 5 67 77 18 74
- 이메일: lavedan.c@chu-toulouse.fr
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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위약 비교기: 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.
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topical application of sweet almond oil around the operated area
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in the total QoR-15F
기간: day 2
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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.
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day 2
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in the total QoR-15F score (Recovery Quality) on postoperative Day 1 (evening)
기간: 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
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Day 1
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Change in the total QoR-15F score (Recovery Quality) on postoperative Day 3 (evening)
기간: 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)
기간: 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
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Week 3
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Change in pain score at Day 0 (= day of surgery)
기간: 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)
기간: 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).
기간: week 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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week 3
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Quantification of the consumption of Nefopam
기간: day 3
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number of ampoules consumed per day.
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day 3
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Quantification of the consumption of morphine derivatives (prescribed as a second-line treatment if Nefopam is ineffective)
기간: day 3
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number of tablets consumed per day
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day 3
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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