NCT07176676

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

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Completed
4 months until next milestone

Study Start

First participant enrolled

November 15, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
9 months until next milestone

First Posted

Study publicly available on registry

September 16, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

2.1 years

First QC Date

July 19, 2022

Last Update Submit

September 9, 2025

Conditions

Keywords

nauseavomitlavandaPostoperative

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

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

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

Other: Usual Care

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.

Lavender Yes

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

Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Postoperative Nausea and VomitingNauseaVomiting

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Non-pharmacological, single-centre, non-profit, randomised controlled trial.
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

Locations