Inhalation Aromatherapy for Patients Undergoing Conservative Sharp Wound Debridement:
ConditionAromatherapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-21
SponsorSingapore General Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Inhalation Aromatherapy
Other interventionPatients 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Inhalation Aromatherapy- Intervention groupExperimental treatment 1 intervention
Group B: Inhalation Placebo-Control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 2027.2
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 3.3
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 3Secondary outcomes
1
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 2027.2
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 3.3
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.Sponsors and contacts
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Source ClinicalTrials.gov