Inhalation Aromatherapy for Patients Undergoing Conservative Sharp Wound Debridement:
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Inhalation Aromatherapy.
- Who it may be relevant to
- Registry conditions: Aromatherapy. Basic parameters: 21 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Singapore
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effectiveness and Acceptability of Inhalation Aromatherapy for Patients Undergoing Conservative Sharp Wound Debridement: A Pilot Randomized Controlled Trial
Overview
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
- 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, E
Primary outcome measures
- Participation Rate [Time frame: Throughout the 12-month data collection period from October 2026 to September 2027.]
- Retention rate [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 [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]
Secondary outcome measures (3)
- Protocol Adherence Rate [Time frame: Assessed throughout the 12-month data collection period from October 2026 to September 2027.]
- Attrition Rate and Extent of Missing Data [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 [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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Singapore · 2 centers
- Singapore General Hospital — Singapore
- Singapore General Hospital — Singapore
Publications
- Rohi Ganji M, Jafari F, Rezaeian S, Abdi H, Farzaei MH, Khatony A. The Effect of Inhalation Aromatherapy and Music Therapy on Anxiety in Patients Undergoing Shockwave Lithotripsy: A Randomized Controlled Clinical Trial. Evid Based Complement Alternat Med. 2022 Jun 29;2022:8015798. doi: 10.1155/2022/8015798. eCollection 2022. PMID 35815287
- RETRACTION: The Role of Orthobiologics in Chronic Wound Healing. Int Wound J. 2025 Aug;22(8):e70744. doi: 10.1111/iwj.70744. PMID 40769517
- Liu YF, Ni PW, Huang Y, Xie T. Therapeutic strategies for chronic wound infection. Chin J Traumatol. 2022 Jan;25(1):11-16. doi: 10.1016/j.cjtee.2021.07.004. Epub 2021 Jul 6. PMID 34315658
- James KA, Stromin JI, Steenkamp N, Combrinck MI. Understanding the relationships between physiological and psychosocial stress, cortisol and cognition. Front Endocrinol (Lausanne). 2023 Mar 6;14:1085950. doi: 10.3389/fendo.2023.1085950. eCollection 2023. PMID 36950689
- Thomas DC, Tsu CL, Nain RA, Arsat N, Fun SS, Sahid Nik Lah NA. The role of debridement in wound bed preparation in chronic wound: A narrative review. Ann Med Surg (Lond). 2021 Oct 4;71:102876. doi: 10.1016/j.amsu.2021.102876. eCollection 2021 Nov. PMID 34745599
- Cui J, Li M, Wei Y, Li H, He X, Yang Q, Li Z, Duan J, Wu Z, Chen Q, Chen B, Li G, Ming X, Xiong L, Qin D. Inhalation Aromatherapy via Brain-Targeted Nasal Delivery: Natural Volatiles or Essential Oils on Mood Disorders. Front Pharmacol. 2022 Apr 12;13:860043. doi: 10.3389/fphar.2022.860043. eCollection 2022. PMID 35496310
- Fiala CA, Abbott LI, Carter CD, Hillis SL, Wolf JS, Schuster M, Dulski R, Grice EA, Rakel BA, Gardner SE. Severe pain during wound care procedures: A cross-sectional study protocol. J Adv Nurs. 2018 May 7:10.1111/jan.13699. doi: 10.1111/jan.13699. Online ahead of print. PMID 29733454
- Matsuzaki K, Upton D. Wound treatment and pain management: a stressful time. Int Wound J. 2013 Dec;10(6):638-44. doi: 10.1111/j.1742-481X.2012.01038.x. Epub 2012 Aug 21. PMID 22905710
Identifiers
NCT: NCT07732036 · ECOS Ref.: 2026-0326 · AM/SU120/2026 (SRDUKAMR26S0)