Aromatherapy
Conditions
Keywords
Venous leg ulcers, Sharp wound debridement, Aromatherapy
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
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.
Sponsors
Singapore General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
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.
Intervention model description
This study employs a control trial design to evaluate the efficacy of inhalation aromatherapy in reducing procedural anxiety and pain during chronic wound debridement. Participants are randomized into either an intervention group receiving an inhalation stick containing a blend of Asian aromatic plant extracts, or a control group receiving an identical inhalation stick containing only jojoba carrier oil with no known anxiolytic properties. Both groups follow a standardized pain management plan, whereby patients consume their existing oral analgesic prior to the clinic visit. The intervention is administered for five minutes before the procedure and continued for up to ten minutes during the procedure. Feasibility and acceptability are assessed alongside primary outcomes, with acceptability measured via a five-point Likert scale satisfaction survey administered at the final visit.
Eligibility
Sex/Gender
ALL
Age
21 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participation Rate | Throughout the 12-month data collection period from October 2026 to September 2027. | The number of recruited patients divided by total eligible patients approached, expressed as a percentage. |
| Retention rate | 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. | The number of patients remaining divided by total patients who consented, expressed as a percentage. |
| Percentage Change in State Anxiety Level During Conservative Sharp Wound Debridement | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Protocol Adherence Rate | Assessed throughout the 12-month data collection period from October 2026 to September 2027. | Protocol adherence, which is given by the proportion of patients correctly receiving the allocated treatment out of all patients who consented to the study. |
| Attrition Rate and Extent of Missing Data | 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. | Attrition rates (withdrawal or loss-to-follow-up as compared to completion of all 3 clinic visits) |
| Change in Pain Intensity During Conservative Sharp Wound Debridement | 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. | Change in pain intensity during CSWD, which is given by the difference in VAS score before and after CSWD |
Countries
Singapore
Contacts
CONTACTNanthakumahrie Gunasegaran
Outcome results
None listed