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

National University Health System (NUHS)

Status: Completed

Conditions: Vitrectomy; Aromatherapy; Cataract; Surgery; Preoperative Anxiety

Treatments: Other: Placebo; Other: Aromatherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07237061

2020/01202

Details and patient eligibility

About

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

Enrollment: 64 patients

Sex: All

Ages: 21+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

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).

Treatment:

Other: Placebo

intervention

Experimental group

Description:

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).

Treatment:

Other: Aromatherapy