Aromatherapy Treatment With Lavender Essential Oil to Reduce Post-Operative Nausea and Vomiting (PONV) (Leo-PONV)

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Status: Active, not recruiting

Conditions: PONV

Treatments: Other: Usual Care; Other: Lavanda Angustifolia essential oil

Study type: Interventional

Funder types: Other

Identifiers

NCT07176676

AziendaABCA

Details and patient eligibility

About

The aim of this study is to evaluate the effectiveness of aromatherapy through the use of inhaled Lavender oil in reducing patients' nausea during the post-operative period.

Full description

To evaluate the effectiveness of inhaling Lavender Angustifolia essential oil in reducing nausea after abdominal, vascular, neurosurgical and gynaecological surgery under general anaesthesia during the 24-hour postoperative period.

Secondary objective

• To detect the number of antiemetic administrations in the experimental arm compared to the control arm
• To measure the patient satisfaction of patients in the experimental group with the Lavender essential oil aromatherapy intervention at hospital discharge Primary endpoint Reduction of nausea by at least 10% compared to treatment with standard care, as assessed by the NRS (Numerical Rating Scale).

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who sign an informed consent

  • Patients who have undergone anesthesiological examination
  • Patients undergoing general anaesthesia
  • Clinically stable patients
  • Patients with nausea scores detected with NRS>0
  • Patients admitted undergoing surgery in the Complex and/or Simple Structures listed below:
  • SC of Neurosurgery, undergoing spinal surgery
  • SC of General Surgery, undergoing surgery on one of the organs of the abdominal cavity
  • SC of Vascular Surgery, undergoing traditional surgical repair or endovascular procedure of abdominal aortic aneurysm. Sclerotherapy (to heal varicose veins) venous stripping (removal of a vein segment in the treatment of varicose veins) laser treatment
  • SS of Gynaecological Surgery, undergoing operations on the organs of the female genital apparatus.

Exclusion criteria

Patients with ongoing relevant cognitive impairment (Six Item Screener score <4)

• Patients with allergies or sensitivities to lavender essential oils
• Patients with asthma, COPD, Chronic Bronchitis, Obstructive Sleep Apnea
• Patients with changes in sense of smell

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

Lavender Yes

Experimental group

Description:

The lavender essential oil may only be used at the first episode of nausea occurring within 24 hours post-surgery; during the same period, if nausea occurs again, it will be treated as per standard care

Treatment:

Other: Lavanda Angustifolia essential oil

Usual Care

Active Comparator group

Description:

Standard procedure, which consists of administering antiemetics if provided in therapy or reporting to the physician with a subsequent treatment decision

Treatment:

Other: Usual Care