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

NCT ID: NCT07176676

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2025-12-15

Brief Summary

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.

Detailed 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).

Conditions

PONV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Lavender Yes

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

Group Type: EXPERIMENTAL

Lavanda Angustifolia essential oil

Intervention Type: OTHER

Administration of Lavender Angustifolia essential oil by inhalation in reducing nausea after abdominal, vascular, neurosurgical and gynaecological surgery under general anaesthesia during the 24-hour postoperative period.

Usual Care

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

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

Patients in the Usual Care group will follow the standard procedure, which consists of administering antiemetics if provided in therapy or reporting to the doctor with a subsequent treatment decision

Interventions

Lavanda Angustifolia essential oil

Administration of Lavender Angustifolia essential oil by inhalation in reducing nausea after abdominal, vascular, neurosurgical and gynaecological surgery under general anaesthesia during the 24-hour postoperative period.

Intervention Type: OTHER

Usual Care

Patients in the Usual Care group will follow the standard procedure, which consists of administering antiemetics if provided in therapy or reporting to the doctor with a subsequent treatment decision

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Trial Center

Alessandria, Italy, Italy

Countries

Italy

Other Identifiers

AziendaABCA

Identifier Type: -

Identifier Source: org_study_id