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AromatherapyNCT07732036

Inhalation Aromatherapy for Patients Undergoing Conservative Sharp Wound Debridement:

A study testing Inhalation Aromatherapy in people with Aromatherapy, run by Singapore General Hospital at 2 sites in Singapore.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 21 years
Conditions the study is for
Aromatherapy
What is being tested?
Inhalation Aromatherapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
2 sitesSingapore
Study dates
5 Jun 2026to 30 Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 21 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Singapore2 sites, 2 recruiting
  • Singapore General Hospital

    Singapore, Singapore

    Singapore General Hospital Singapore General Hospital, 65762590 ext. +65, nurshing.research@sgh.com.sg

    Recruiting
  • Singapore General Hospital

    Singapore, Singapore

    Singapore General Hospital Singapore General Hospital, 65762590 ext. +65, nursing.research@sgh.com.sg

    Recruiting

Other trials in Singapore

About this study

Official title: The Effectiveness and Acceptability of Inhalation Aromatherapy for Patients Undergoing Conservative Sharp Wound Debridement: A Pilot Randomized Controlled 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?

Read more

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
Being tested
Inhalation Aromatherapy
Keywords
Venous leg ulcers, Sharp wound debridement, Aromatherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inhalation AromatherapyOther

    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.

Study groups in NCT07732036
Study groupRoleWhat they receive
Inhalation Aromatherapy- Intervention groupExperimentalParticipants 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.
Receives: Other: Inhalation Aromatherapy
Inhalation Placebo-Control groupPlacebo comparatorParticipants 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.
Receives: Other: Inhalation Aromatherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participation Rate

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

    Measured: 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.

    Measured: 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.

    Measured: 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)
  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.

    Measured: 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)

    Measured: 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

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2026
  2. Study start5 Jun 2026
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07732036
Sponsor's protocol ID
ECOS Ref.: 2026-0326
Other IDs
AM/SU120/2026 (SRDUKAMR26S0)
Status last verified
Jul 2026
First submitted
17 Jun 2026
Last updated
28 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 35815287
  • RETRACTION: The Role of Orthobiologics in Chronic Wound Healing. Int Wound J. 2025 Aug;22(8):e70744. doi: 10.1111/iwj.70744.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 22905710
  • Hedigan F, Sheridan H, Sasse A. Benefit of inhalation aromatherapy as a complementary treatment for stress and anxiety in a clinical setting - A systematic review. Complement Ther Clin Pract. 2023 Aug;52:101750. doi: 10.1016/j.ctcp.2023.101750. Epub 2023 Apr 5.

    PubMed 37031643
  • Zhang N, Yao L. Anxiolytic Effect of Essential Oils and Their Constituents: A Review. J Agric Food Chem. 2019 Dec 18;67(50):13790-13808. doi: 10.1021/acs.jafc.9b00433. Epub 2019 Jun 13.

    PubMed 31148444
  • Woo KY. Chronic wound-associated pain, psychological stress, and wound healing. Surg Technol Int. 2012 Dec;22:57-65.

    PubMed 23023574
  • Brown A. The assessment and treatment of wound pain. Nurs Times. 2015 Nov 18-24;111(47):15-7.

    PubMed 26721090
  • Kiecolt-Glaser JK, Marucha PT, Malarkey WB, Mercado AM, Glaser R. Slowing of wound healing by psychological stress. Lancet. 1995 Nov 4;346(8984):1194-6. doi: 10.1016/s0140-6736(95)92899-5.

    PubMed 7475659
  • McGuire L, Heffner K, Glaser R, Needleman B, Malarkey W, Dickinson S, Lemeshow S, Cook C, Muscarella P, Melvin WS, Ellison EC, Kiecolt-Glaser JK. Pain and wound healing in surgical patients. Ann Behav Med. 2006 Apr;31(2):165-72. doi: 10.1207/s15324796abm3102_8.

    PubMed 16542131
  • Briggs M, Nelson EA, Martyn-St James M. Topical agents or dressings for pain in venous leg ulcers. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD001177. doi: 10.1002/14651858.CD001177.pub3.

    PubMed 23152206

Questions about this trial

What is this clinical trial studying?

A study testing Inhalation Aromatherapy in people with Aromatherapy, run by Singapore General Hospital at 2 sites in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nanthakumahrie Gunasegaran (97250435 ext. +65, nanthakumahrie.gunasegaran@sgh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participation Rate (time frame: Throughout the 12-month data collection period from October 2026 to September 2027.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07732036, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.

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