The Effect of Inhalation Aromatherapy on Intraoperative Fear in Patients Undergoing Lower Blepharoplasty Under Local Anesthesia: A Randomized Controlled Trial

The Effect of Inhalation Aromatherapy on Intraoperative Fear in Patients Undergoing Lower Blepharoplasty Under Local Anesthesia: A Randomized Controlled 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.

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.

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