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NCT07732036

Overview

NCT ID: NCT07732036
Lead Sponsor: Singapore General HospitalOTHER
Official Title: The Effectiveness and Acceptability of Inhalation Aromatherapy for Patients Undergoing Conservative Sharp Wound Debridement: A Pilot Randomized Controlled Trial
Brief Summary: The goal of this pilot clinical trial is to learn if inhalation aromatherapy works to reduce anxiety and pain in patients with venous leg ulcers undergoing conservative sharp wound debridement (CSWD). It will also learn about the feasibility of implementing this intervention in clinical practice. The main questions it aims to answer are:

Does inhalation aromatherapy reduce anxiety levels during CSWD procedures, as measured by STAI-S scores? Does inhalation aromatherapy reduce pain intensity during CSWD procedures? Is inhalation aromatherapy feasible and acceptable to implement in a clinical setting? What are the protocol adherence rates and potential areas of missing data?

Researchers will compare inhalation aromatherapy using Asian essential oil extracts to standard care to see if aromatherapy works to reduce anxiety and pain during wound debridement.

Participants will:

Receive either inhalation aromatherapy or standard care during their CSWD procedure Complete State-Trait Anxiety Inventory (STAI-S) questionnaires before and after the procedure Rate their pain intensity using visual analog scales during the debridement Provide feedback on treatment satisfaction and acceptability Attend clinic visits for wound debridement as part of their standard care

This pilot study hypothesizes that inhalation aromatherapy is feasible and acceptable to implement in a clinical setting and may be associated with differences in anxiety and pain intensity during CSWD, compared to standard care

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 28, 2026Actual
Start Date: Jun 5, 2026Actual
Primary Completion Date: Sep 30, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

-≥21 years old

-Venous leg ulcers requiring conservative sharp wound debridement

Exclusion Criteria:

Known sensitivity or hypersensitivity to essential oils or any components in the Aromatherapy scent formulation

Allergic rhinitis, asthma, chronic lung disease or any disease that impairs the sense of smell

Airway hypersensitivity to fragrances, paint/gasoline fumes or turpentine

Using aromatherapy of any kind

Taking any anti-psychotic drugs

Incapable of providing verbal/written consent

On anti-anxiety medications

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 40Estimated
Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: Nanthakumahrie GunasegaranContact
nanthakumahrie.gunasegaran@sgh.com.sg

Similar Studies

Masking Description

Participants will be allocated to either the Inhalation Aromatherapy intervention group or the Inhalation Placebo control group in a 1:1 ratio using randomly permuted block randomization, ensuring balanced allocation throughout the recruitment period. The randomization sequence will be generated by an independent member not involved in recruitment, intervention delivery, or outcome assessment, keeping the allocation process free from investigator influence. Upon confirmation of eligibility and informed consent, each participant will be assigned according to the pre-generated sequence. Allocation concealment will be maintained until the point of assignment, with block sizes kept undisclosed to further safeguard concealment. This rigorous process strengthens internal validity and supports a fair and unbiased comparison across the planned 40-participant sample. Unblinding will only occur after all data have been collected and locked.

Participant Group/Arms

Inhalation Aromatherapy- Intervention groupExperimental

Participants allocated to the intervention group receive a personal nasal inhalation stick infused with a blend of Asian aromatic plant extracts formulated by a qualified aromatherapist, selected based on known anxiolytic and analgesic pharmacological properties. The final blend is determined through a scent preference evaluation conducted with five VLU patient volunteers prior to the main study. Participants inhale the stick for 5 minutes before entering the clinic room and continue using it throughout the CSWD procedure for up to 10 minutes or until the procedure is completed, inhaling at least twice in each nostril prior to the procedure. Aromatherapy works through positive olfactory effects and direct modulation of the amygdala via the olfactory nerve, potentially reducing anxiety and enhancing comfort during the procedure. Each participant is issued their own inhalation stick for personal use across all study visits to maintain hygiene and ensure consistent dosing.

Other: Inhalation Aromatherapy

Inhalation Placebo-Control groupPlacebo Comparator

Participants allocated to the control group receive a personal nasal inhalation stick identical in appearance, size, and packaging to the intervention stick, containing certified organic jojoba carrier oil with no known anxiolytic properties. Jojoba oil has a barely perceptible, slightly sweet aroma and is widely used in aromatherapy blends. Participants follow an identical inhalation protocol to the intervention group, inhaling for 5 minutes before the procedure and continuing throughout CSWD for up to 10 minutes or until the procedure is completed. This ensures that any non-specific effects of the inhalation ritual, including focused breathing and expectation of benefit, are equally present in both arms, thereby isolating the specific pharmacological effect of the aromatic compounds.

Other: Inhalation Aromatherapy