About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Single group
Treatments tested in this trial
inhaled aromatherapy
Other interventionA sterile cotton ball with 2 drops of lavender essential oil was placed 10 cm from the nose
Treatment groups
Trial outcomes
Primary outcomes
intraoperative fear score
intraoperative fear score measured by the Visual Analogue Scale for Fear (VAS-Fear)
Secondary outcomes
VAS-Fear score during local anesthetic injection
VAS-Fear score during local anesthetic injection
Visual Analogue Sacle for Pain (VAS-Pain) score during local anesthetic injection
VAS-Pain score during local anesthetic injection
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
intraoperative cooperation
A 1-5 scale (from extreme poor cooperation to excellent cooperation) for subjective evaluation of surgical cooperation by the surgeon
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: