Inhalation Aromatherapy for Patients Undergoing Conservative Sharp Wound Debridement:
The Effectiveness and Acceptability of Inhalation Aromatherapy for Patients Undergoing Conservative Sharp Wound Debridement: A Pilot Randomized Controlled Trial
Singapore General Hospital
40 participants
Jun 5, 2026
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria2
- ≥21 years old
- Venous leg ulcers requiring conservative sharp wound debridement
Exclusion Criteria7
- 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
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Interventions
Patients are allocated to either the Inhalation Aromatherapy or Inhalation Placebo group in a 1:1 ratio via randomly permuted block randomization. The randomization sequence is generated by a non-study member using a computer-generated program. Allocation concealment is maintained through the use of sequentially numbered, opaque, sealed envelopes to prevent selection . Inhalation aromatherapy intervention an inhalation stick containing a blend of Asian aromatic plant extracts, including Basil, Elemi, and Calamansi, specifically selected for their pharmacological properties in alleviating anxiety, agitation, stress, and pain. Unlike conventional pharmacological interventions, the dose is not fixed but individually determined by the frequency of inhalation, varying based on individual pharmacokinetics and personal response to the aroma. Patients inhale at least twice, once in each nostril, beginning five minutes before the procedure and continuing throughout CSWD for up to ten minutes.
Locations(2)
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NCT07732036