Lower Eyelid Bags
Conditions
Keywords
Lower eyelid bags, lower blepharoplasty, inhaled aromatherapy, intraoperative fear score, fear score during local anesthetic injection
Brief 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.
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.
Interventions
OTHERinhaled aromatherapy
A sterile cotton ball with 2 drops of lavender essential oil was placed 10 cm from the nose
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-65 years, either sex 2. Scheduled for elective bilateral lower blepharoplasty (eyelid bag surgery) 3. Anesthesia: pure local anesthesia (lidocaine and/or ropivacaine) without any sedative agents 4. ASA physical status I-II 5. Alert and oriented, able to understand and complete questionnaires correctly 6. Normal olfactory function (able to distinguish among coffee, alcohol, and vanilla) 7. Voluntary participation with signed informed consent
Exclusion criteria
1. History of allergy to lavender essential oil or any botanical essential oil 2. Diagnosed olfactory disorder, chronic rhinitis, asthma, COPD, or other respiratory diseases 3. Preoperative use of anxiolytics, sedatives, or opioid analgesics 4. History of psychiatric disorders, cognitive impairment, or needle phobia (trypanophobia) 5. Pregnant or breastfeeding women 6. Participation in another clinical trial within the past month 7. Any other condition deemed by the investigator as unsuitable for study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative fear score | 1 day | intraoperative fear score measured by the Visual Analogue Scale for Fear (VAS-Fear) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS-Fear score during local anesthetic injection | 1 day | VAS-Fear score during local anesthetic injection |
| Visual Analogue Sacle for Pain (VAS-Pain) score during local anesthetic injection | 1 day | VAS-Pain score during local anesthetic injection |
| changes in state anxiety | 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 |
| intraoperative cooperation | 1 day | A 1-5 scale (from extreme poor cooperation to excellent cooperation) for subjective evaluation of surgical cooperation by the surgeon |
| surgical satisfaction | 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 |
| changes in physiological parameters | 1 day | changes in physiological parameters (including heart rate, blood pressure, blood oxygen saturation, et. al.) immediately before and immediately after surgery completition |
Countries
China
Contacts
CONTACTYun Ge Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Outcome results
None listed