Patient-preferred Aromatherapy Versus Placebo For Reducing Preoperative Anxiety In Patients Undergoing Eye Surgery

NCT07237061 | Completed

• 1 other identifier: 2020/01202
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This study looks at whether aromatherapy (scent chosen by the patient), is better than routine care, at reducing preoperative anxiety before eye surgery.

Conditions

Cataract; Surgery; Vitrectomy; Aromatherapy; Preoperative Anxiety

Keywords

randomized controlled trial; placebo controlled; double blinded; two arm

Outcome Measures

Primary Outcomes (1)

• change in VAS scores for preoperative anxiety

  preoperative anxiety was ranked by the patient on a scale of 0-100 on a visual acuity scale (VAS) measuring 100mm, in the preoperative ambulatory ward, before and after the intervention/placebo was applied for at least 30 minutes. The change in the VAS score at these 2 timepoints was the primary outcome

  30-60 minutes

Study Arms (2)

placebo

PLACEBO COMPARATOR

Patients were asked to choose amongst 4 different aromatherapy scents. The study administrator then stuck an adhesive patch without any aromatherapy oil on it, to the patient's facemask. This was worn throughout the perioperative experience from the ambulatory ward to the operating theatre and post anaesthesia care unit (PACU).

Other: Placebo

intervention

EXPERIMENTAL

Patients were asked to choose amongst 4 different aromatherapy scents. The study administrator then stuck an adhesive patch with 1 drop of their chosen aromatherapy oil on it, to the patient's facemask. This was worn throughout the perioperative experience from the ambulatory ward to the operating theatre and post anaesthesia care unit (PACU).

Other: Aromatherapy

Interventions

Aromatherapy OTHER

patients chose their preferred aromatherapy scent to be used for at least 30 minutes

Also known as: lavender, geranium, lemongrass, sandalwood

intervention

Placebo OTHER

odorless dry absorbent adhesive patch

placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• mental capacity for informed consent
• undergoing elective ambulatory eye surgery (including Phacoemulsification, Femtosecond laser-assisted cataract surgery (FLACS), Extracapsular cataract extraction (ECCE) and vitrectomy).
• surgery only under Monitored Anaesthesia Care (MAC)3
• surgical duration less than 45 minutes

You may not qualify if:

• anosmia
• allergy to aromatherapy oil
• asthma
• allergic rhinitis
• psychiatric disease
• altered mental state
• lack of mental capacity
• active infection
• pregnancy
• patient or surgeon refused participation

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital Singapore

Singapore, Singapore

Location

MeSH Terms

Conditions

Cataract

Interventions

Aromatherapy; lavender oil; lemongrass oil

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: November 19, 2025
• Study Start: March 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: December 1, 2024
• Last Updated: November 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)