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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
152
A sterile cotton ball with 2 drops of lavender essential oil was placed 10 cm from the nose
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
intraoperative fear score
intraoperative fear score measured by the Visual Analogue Scale for Fear (VAS-Fear)
Time frame: 1 day
VAS-Fear score during local anesthetic injection
VAS-Fear score during local anesthetic injection
Time frame: 1 day
Visual Analogue Sacle for Pain (VAS-Pain) score during local anesthetic injection
VAS-Pain score during local anesthetic injection
Time frame: 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
Time frame: 1 day
intraoperative cooperation
A 1-5 scale (from extreme poor cooperation to excellent cooperation) for subjective evaluation of surgical cooperation by the surgeon
Time frame: 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
Time frame: 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
Time frame: 1 day
Yun Ge Sun Yat-sen Memorial Hospital, Sun Yat-sen University
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