Inhalation Aromatherapy for Patients Undergoing Conservative Sharp Wound Debridement:

Официальное название

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

Обзор

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

Вмешательства

• Другое 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

Первичные конечные точки

• Participation Rate [Срок оценки: Throughout the 12-month data collection period from October 2026 to September 2027.]
• Retention rate [Срок оценки: 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 [Срок оценки: 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]

Вторичные конечные точки (3)

• Protocol Adherence Rate [Срок оценки: Assessed throughout the 12-month data collection period from October 2026 to September 2027.]
• Attrition Rate and Extent of Missing Data [Срок оценки: 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 [Срок оценки: 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.]

Критерии участия

Критерии включения

-≥21 years old

-Venous leg ulcers requiring conservative sharp wound debridement

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Сингапур · 2 центра

• Singapore General Hospital — Singapore
• Singapore General Hospital — Singapore

Публикации

• 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

Идентификаторы

NCT: NCT07732036 · ECOS Ref.: 2026-0326 · AM/SU120/2026 (SRDUKAMR26S0)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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