An interventional study of Inhalation Aromatherapy in Aromatherapy, sponsored by Singapore General Hospital. Recruiting at 2 sites in Singapore. Open to participants aged 21 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Singapore General Hospital · Not applicable, Interventional, and Supportive care
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
Singapore General Hospital is the lead sponsor of 270 studies on the registry; 57 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
-≥21 years old
-Venous leg ulcers requiring conservative sharp wound debridement
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Participation Rate
The number of recruited patients divided by total eligible patients approached, expressed as a percentage.
Time frame: Throughout the 12-month data collection period from October 2026 to September 2027.
Retention rate
The number of patients remaining divided by total patients who consented, expressed as a percentage.
Time frame: The number of participants completed 3rd clinic visit/15th day, across the 12-month data collection period from October 2026 to September 2027. Clinic visit 1 - 1st Day- week 1, Clinic visit 2 -8th Day- week 2, Clinic visit 3- 15th Day- week 3.
Percentage Change in State Anxiety Level During Conservative Sharp Wound Debridement
Percentage change in STAI-S score at T1 (2nd clinic visit/2nd week/8th day): (pre-CSWD STAI-S minus post-CSWD STAI-S) divided by pre-CSWD STAI-S, multiplied by 100. Unit: percentage change on STAI-S scale. Percentage change in STAI-S score at T2 (3rd clinic visit/3rd week/15th Day), calculated. Unit: percentage change on STAI-S scale. Reported separately to assess sustainability of effect over time.
Time frame: Completed at 3rd clinic visit/15th day, across the 12-month data collection period from October 2026 to September 2027. Clinic visit 1 - 1st Day- week 1, Clinic visit 2 -8th Day- week 2, Clinic visit 3- 15th Day- week 3
Protocol Adherence Rate
Protocol adherence, which is given by the proportion of patients correctly receiving the allocated treatment out of all patients who consented to the study.
Time frame: Assessed throughout the 12-month data collection period from October 2026 to September 2027.
Attrition Rate and Extent of Missing Data
Attrition rates (withdrawal or loss-to-follow-up as compared to completion of all 3 clinic visits)
Time frame: Assessed through the 12-month data collection period from October 2026 to September 2027. Clinic visit 1 - 1st Day- week 1, Clinic visit 2 -8th Day- week 2, Clinic visit 3- 15th Day- week 3.
Change in Pain Intensity During Conservative Sharp Wound Debridement
Change in pain intensity during CSWD, which is given by the difference in VAS score before and after CSWD
Time frame: Change in pain intensity measured pre- and post-CSWD at T1 (2nd Clinic visit/8th Day) and T2 (3rd Clinic visit/15th Day) to assess sustainability, using (VAS), scored 0-100mm. Clinic visit 2 -8th Day- week 2, Clinic visit 3 -15th Day -week3.
Started Jun 2026 (actual). Primary completion is estimated for Sep 2027, 15 months after the start.
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