Lower Eyelid BagsPhase 2NCT07766902
The Effect of Inhalation Aromatherapy on Intraoperative Fear in Patients Undergoing Lower Blepharoplasty Under Local Anesthesia: A Randomized Controlled Trial
A Phase 2 study testing inhaled aromatherapy in people with Lower Eyelid Bags, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lower Eyelid Bags
- What is being tested?
- inhaled aromatherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 31 Mar 2027
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yun Ge Sun Yat-sen Memorial Hospital, Sun Yat-sen University contact
China1 site
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
Yun Ge Sun Yat-sen Memorial Hospital, Sun Yat-sen University, 020-34070349, geyun@mail.sysu.edu.cn
About this study
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.
Read the 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.
- Conditions
- Lower Eyelid Bags
- Being tested
- inhaled aromatherapy
- Keywords
- Lower eyelid bags, lower blepharoplasty, inhaled aromatherapy, intraoperative fear score, fear score during local anesthetic injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhaled aromatherapyOther
A sterile cotton ball with 2 drops of lavender essential oil was placed 10 cm from the nose
| Study group | Role | What they receive |
|---|---|---|
| inhaled aromatherapy | Experimental | A sterile cotton ball with 2 drops of lavender essential oil was placed 10 cm from the nose Receives: Other: inhaled aromatherapy |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative fear score
intraoperative fear score measured by the Visual Analogue Scale for Fear (VAS-Fear)
Measured: 1 day
Secondary outcomes (6)
VAS-Fear score during local anesthetic injection
VAS-Fear score during local anesthetic injection
Measured: 1 day
Visual Analogue Sacle for Pain (VAS-Pain) score during local anesthetic injection
VAS-Pain score during local anesthetic injection
Measured: 1 day
changes in state anxiety
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
Measured: 1 day
intraoperative cooperation
A 1-5 scale (from extreme poor cooperation to excellent cooperation) for subjective evaluation of surgical cooperation by the surgeon
Measured: 1 day
surgical satisfaction
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
Measured: 1 day
changes in physiological parameters
changes in physiological parameters (including heart rate, blood pressure, blood oxygen saturation, et. al.) immediately before and immediately after surgery completition
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Eyelid BagsStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766902
- Sponsor's protocol ID
- SYSKY-2026-441-02
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chang M, Schaefer J, Leonard A, Ellison PR, Cui R, Evans R, Calvert N, Thuro B, Fay A, Nguyen J. The Effect of Aromatherapy on Anxiety and Pain in Patients Undergoing Oculoplastic Surgery. Ophthalmic Plast Reconstr Surg. 2024 Nov-Dec 01;40(6):677-680. doi: 10.1097/IOP.0000000000002692. Epub 2024 May 22.
PubMed 38776147
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Inhalation Aromatherapy on Intraoperative Fear in Patients Undergoing Lower Blepharoplasty Under Local Anesthesia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07766902
- Acronym / sponsor ID
- SYSKY-2026-441-02
- Conditions
- Lower Eyelid Bags
- Keywords
- Lower eyelid bags, lower blepharoplasty, inhaled aromatherapy, intraoperative fear score, fear score during local anesthetic injection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 17 Aug 2026 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inhaled aromatherapy | Experimental | Other: inhaled aromatherapyA sterile cotton ball with 2 drops of lavender essential oil was placed 10 cm from the nose |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| inhaled aromatherapyA sterile cotton ball with 2 drops of lavender essential oil was placed 10 cm from the nose | Other | inhaled aromatherapy |
Primary outcome
intraoperative fear score
Time frame: 1 day
intraoperative fear score measured by the Visual Analogue Scale for Fear (VAS-Fear)
6 secondary outcomes
VAS-Fear score during local anesthetic injection
Time frame: 1 day
Visual Analogue Sacle for Pain (VAS-Pain) score during local anesthetic injection
Time frame: 1 day
changes in state anxiety
Time frame: 1 day
intraoperative cooperation
Time frame: 1 day
surgical satisfaction
Time frame: 1 day
changes in physiological parameters
Time frame: 1 day
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 17 Aug 2026.
- Background: PubMed 38776147Chang M, Schaefer J, Leonard A, Ellison PR, Cui R, Evans R, Calvert N, Thuro B, Fay A, Nguyen J. The Effect of Aromatherapy on Anxiety and Pain in Patients Undergoing Oculoplastic Surgery. Ophthalmic Plast Reconstr Surg. 2024 Nov-Dec 01;40(6):677-680. doi: 10.1097/IOP.0000000000002692. Epub 2024 May 22.
- Individual participant dataSharing planned: No
Related trials for Lower Eyelid Bags
Enrolling by invitation
Non-invasive Rejuvenation of the Periorbital Area and Lower Eyelid
Periorbital Wrinkles, Periorbital Area
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.
Yun Ge Sun Yat-sen Memorial Hospital, Sun Yat-sen University contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing inhaled aromatherapy in people with Lower Eyelid Bags, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
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 7 inclusion and 7 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: opening soon, as of the sponsor's last update on 17 Aug 2026. 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 China. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Yun Ge Sun Yat-sen Memorial Hospital, Sun Yat-sen University (020-34070349, geyun@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraoperative fear score (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07766902, which also lists 1 linked publication.
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 17 Aug 2026.