PONVLeo-PONVNCT07176676
Aromatherapy Treatment With Lavender Essential Oil to Reduce Post-Operative Nausea and Vomiting (PONV)
A study testing Lavanda Angustifolia essential oil in people with PONV, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PONV
- What is being tested?
- Lavanda Angustifolia essential oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteItaly
- Study dates
- 15 Nov 2022to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Being tested
- Lavanda Angustifolia essential oil, Usual Care
- Keywords
- nausea, vomit, lavanda, Postoperative
- Medical subject headings
- Postoperative Nausea and Vomiting, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavanda Angustifolia essential oilOther
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 CareOther
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
| Study group | Role | What they receive |
|---|---|---|
| Lavender Yes | Experimental | 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 Receives: Other: Lavanda Angustifolia essential oil |
| Usual Care | Active comparator | Standard procedure, which consists of administering antiemetics if provided in therapy or reporting to the physician with a subsequent treatment decision Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
To measure the number of antiemetic administrations in the experimental arm compared to the control arm
Measured: 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
To measure the patient satisfaction of the patients in the experimental group regarding the aromatherapy intervention with Lavender essential oil at hospital discharge
Measured: during the 24-hour postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start15 Nov 2022
- Primary completion31 Dec 2024
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PONVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non-pharmacological, single-centre, non-profit, randomised controlled trial.
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07176676
- Sponsor's protocol ID
- AziendaABCA
- Acronym
- Leo-PONV
- Status last verified
- Sep 2025
- First submitted
- 19 Jul 2022
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07176676
- Acronym / sponsor ID
- Leo-PONV / AziendaABCA
- Conditions
- PONV
- Keywords
- nausea, vomit, lavanda, Postoperative
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di AlessandriaUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-pharmacological, single-centre, non-profit, randomised controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Lavender Yes | Experimental | Other: Lavanda Angustifolia essential oilThe 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 comparator | Other: Usual CareStandard procedure, which consists of administering antiemetics if provided in therapy or reporting to the physician with a subsequent treatment decision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients who sign an informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lavanda Angustifolia essential oilAdministration 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. | Other | Lavender Yes |
| Usual CarePatients 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 | Other | Usual Care |
Primary outcome
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
Time frame: during the 24-hour post-operative 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).
2 secondary outcomes
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
Time frame: 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
Time frame: during the 24-hour postoperative period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lavanda Angustifolia essential oil in people with PONV, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: during the 24-hour post-operative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.