Aromatherapy Treatment With Lavender Essential Oil to Reduce Post-Operative Nausea and Vomiting (PONV)
Leo-PONV
Evaluation of the Efficacy of an Aromatherapy Treatment With Lavender Essential Oil to Reduce Post-Operative Nausea and Vomiting (PONV): Two-arm, Non-pharmacological, Single-centre, Non-profit, Randomised Controlled Trial
1 other identifier
interventional
128
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2022
CompletedStudy Start
First participant enrolled
November 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedFirst Posted
Study publicly available on registry
September 16, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2025
CompletedSeptember 16, 2025
September 1, 2025
2.1 years
July 19, 2022
September 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the effectiveness of administering 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
To reduce nausea after abdominal, vascular, neurosurgical and gynaecological surgery under general anaesthesia during the 24-hour postoperative period. Endpoint Reduction of nausea by at least 10% compared to treatment with standard care, as assessed by the NRS (Numerical Rating Scale).
during the 24-hour post-operative period
Secondary Outcomes (2)
To evaluate the effectiveness of administering 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
during the 24-hour postoperative period
o evaluate the effectiveness of administering 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
during the 24-hour postoperative period
Study Arms (2)
Lavender Yes
EXPERIMENTALThe 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
Usual Care
ACTIVE COMPARATORStandard procedure, which consists of administering antiemetics if provided in therapy or reporting to the physician with a subsequent treatment decision
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Trial Center
Alessandria, Italy, 15121, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2022
First Posted
September 16, 2025
Study Start
November 15, 2022
Primary Completion
December 31, 2024
Study Completion
December 15, 2025
Last Updated
September 16, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share