Inhalation Aromatherapy for Patients Undergoing Conservative Sharp Wound Debridement:

NCT07732036 | Recruiting DMC

• 2 other identifiers: ECOS Ref.: 2026-0326AM/SU120/2026 (SRDUKAMR26S0)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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

Conditions

Aromatherapy

Keywords

Venous leg ulcers; Sharp wound debridement; Aromatherapy

Outcome Measures

Primary Outcomes (3)

• Participation Rate

  The number of recruited patients divided by total eligible patients approached, expressed as a percentage.

  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.

  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.

  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

Secondary Outcomes (3)

• Protocol Adherence Rate

  Assessed throughout the 12-month data collection period from October 2026 to September 2027.

• 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.

• 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.

Study Arms (2)

Inhalation Aromatherapy- Intervention group

EXPERIMENTAL

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 group

PLACEBO 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

Interventions

Inhalation Aromatherapy OTHER

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.

Inhalation Aromatherapy- Intervention group; Inhalation Placebo-Control group

Eligibility Criteria

• Age: 21 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ≥21 years old
• Venous leg ulcers requiring conservative sharp wound debridement

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (2)

Singapore General Hospital

Singapore, Singapore, Singapore

RECRUITING

Singapore General Hospital

Singapore, Singapore, Singapore

RECRUITING

Related Publications (22)

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Central Study Contacts

Nanthakumahrie Gunasegaran

CONTACT

97250435; nanthakumahrie.gunasegaran@sgh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: July 28, 2026
• Study Start: June 5, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): March 30, 2028
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

SG (2)