The Effect of Inhalation Aromatherapy on Intraoperative Fear in Patients Undergoing Lower Blepharoplasty Under Local Anesthesia: A Randomized Controlled Trial
August 11, 2026 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
This study is a single-center, randomized, controlled, open-label clinical trial designed to evaluate the intervention effect of inhaled aromatherapy on intraoperative fear in patients undergoing lower blepharoplasty (eyelid bag surgery) under local anesthesia.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
This study is a single-center, randomized, controlled, open-label clinical trial designed to evaluate the intervention effect of inhaled aromatherapy on intraoperative fear in patients undergoing lower blepharoplasty (eyelid bag surgery) under local anesthesia.
A total of 152 adult patients scheduled for elective bilateral lower blepharoplasty under pure local anesthesia (lidocaine and/or ropivacaine) without any sedative agents will be enrolled.
Patients will be randomly assigned in a 1:1 ratio to either the experimental group (inhaled aromatherapy) or the control group (standard care).
The primary outcome is the intraoperative fear score measured by the Visual Analogue Scale for Fear (VAS-Fear).
Secondary outcomes include fear score during local anesthetic injection, pain during local anesthetic injection, changes in state anxiety, intraoperative cooperation, surgical satisfaction, and changes in physiological parameters.
Lavender essential oil will be used for aromatherapy, and patients may choose to use it voluntarily.
An intensified intervention protocol (forward positioning of the cotton pad + nurse hand-holding + breathing guidance) will be implemented during the critical period of local anesthetic injection.
This study will be conducted in accordance with the Declaration of Helsinki and will commence after approval by the Ethics Committee.
All participants will provide written informed consent.
Study Type
Interventional
Enrollment (Estimated)
152
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yun Ge Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Phone Number: 020-34070349
- Email: geyun@mail.sysu.edu.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510120
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
-
Contact:
- Yun Ge Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Phone Number: 020-34070349
- Email: geyun@mail.sysu.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age 18-65 years, either sex
- Scheduled for elective bilateral lower blepharoplasty (eyelid bag surgery)
- Anesthesia: pure local anesthesia (lidocaine and/or ropivacaine) without any sedative agents
- ASA physical status I-II
- Alert and oriented, able to understand and complete questionnaires correctly
- Normal olfactory function (able to distinguish among coffee, alcohol, and vanilla)
- Voluntary participation with signed informed consent
Exclusion Criteria:
- History of allergy to lavender essential oil or any botanical essential oil
- Diagnosed olfactory disorder, chronic rhinitis, asthma, COPD, or other respiratory diseases
- Preoperative use of anxiolytics, sedatives, or opioid analgesics
- History of psychiatric disorders, cognitive impairment, or needle phobia (trypanophobia)
- Pregnant or breastfeeding women
- Participation in another clinical trial within the past month
- Any other condition deemed by the investigator as unsuitable for study participation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
No intervention
|
|
|
Experimental: inhaled aromatherapy
A sterile cotton ball with 2 drops of lavender essential oil was placed 10 cm from the nose
|
A sterile cotton ball with 2 drops of lavender essential oil was placed 10 cm from the nose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
intraoperative fear score
Time Frame: 1 day
|
intraoperative fear score measured by the Visual Analogue Scale for Fear (VAS-Fear)
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VAS-Fear score during local anesthetic injection
Time Frame: 1 day
|
VAS-Fear score during local anesthetic injection
|
1 day
|
|
Visual Analogue Sacle for Pain (VAS-Pain) score during local anesthetic injection
Time Frame: 1 day
|
VAS-Pain score during local anesthetic injection
|
1 day
|
|
changes in state anxiety
Time Frame: 1 day
|
State-Trait Anxiety Inventory (STAI) Score (including STAI-State and STAI-Trait) is measured 30 minutes before surgery, immediately before surgery, and immediately after surgery completetion
|
1 day
|
|
intraoperative cooperation
Time Frame: 1 day
|
A 1-5 scale (from extreme poor cooperation to excellent cooperation) for subjective evaluation of surgical cooperation by the surgeon
|
1 day
|
|
surgical satisfaction
Time Frame: 1 day
|
A 1-5 scale (from very dissatisfied to very satisfied) for subjective evaluation of surgical satisfaction by the patient as well as VAS-Satisfaction score, which are measured immediately after surgery and 1 day after surgery
|
1 day
|
|
changes in physiological parameters
Time Frame: 1 day
|
changes in physiological parameters (including heart rate, blood pressure, blood oxygen saturation, et.
al.) immediately before and immediately after surgery completition
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 1, 2026
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2027
Study Registration Dates
First Submitted
July 22, 2026
First Submitted That Met QC Criteria
August 11, 2026
First Posted (Actual)
August 17, 2026
Study Record Updates
Last Update Posted (Actual)
August 17, 2026
Last Update Submitted That Met QC Criteria
August 11, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SYSKY-2026-441-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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