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

November 17, 2025 updated by: National University Hospital, Singapore

Patient-preferred Aromatherapy Versus Placebo For Reducing Preoperative Anxiety In Patients Undergoing Eye Surgery - The RELAAC Randomised Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore
        • National University Hospital Singapore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
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
odorless dry absorbent adhesive patch
Experimental: intervention
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
patients chose their preferred aromatherapy scent to be used for at least 30 minutes
Other Names:
  • lavender
  • geranium
  • lemongrass
  • sandalwood

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in VAS scores for preoperative anxiety
Time Frame: 30-60 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

March 31, 2024

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

June 26, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 19, 2025

Study Record Updates

Last Update Posted (Actual)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/01202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

local Patient Data Protection Act

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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