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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07237061

Acronym

RELAAC

Enrollment

Registered

2025-11-19

Start date

2023-03-01

Completion date

2024-12-01

Last updated

2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aromatherapy, Cataract, Preoperative Anxiety, Surgery, Vitrectomy

Keywords

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

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.

Interventions

OTHERAromatherapy

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

OTHERPlacebo

odorless dry absorbent adhesive patch

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
change in VAS scores for preoperative anxiety	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

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026