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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • inhaled aromatherapy

    Other intervention

    A sterile cotton ball with 2 drops of lavender essential oil was placed 10 cm from the nose

Treatment groups

152 Participants
are divided into 2 treatment groups
Group A: inhaled aromatherapyExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

intraoperative fear score

intraoperative fear score measured by the Visual Analogue Scale for Fear (VAS-Fear)

Time frame
1 day

Secondary outcomes

1

VAS-Fear score during local anesthetic injection

VAS-Fear score during local anesthetic injection

Time frame
1 day
2

Visual Analogue Sacle for Pain (VAS-Pain) score during local anesthetic injection

VAS-Pain score during local anesthetic injection

Time frame
1 day
3

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
4

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

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: