Evaluating the Feasibility and Acceptability of Inhalation Aromatherapy for Patients Undergoing Autologous Haematopoietic Stem Cell Transplant (HSCT)

Официальное название

Evaluating the Feasibility and Acceptability of Inhalation Aromatherapy for Reducing Chemotherapy-Induced Nausea and Vomiting (CINV) in Patients Undergoing Autologous Haematopoietic Stem Cell Transplant (HSCT): A Pilot Study

Обзор

The goal of this clinical trial is to evaluate whether aromatherapy inhaler sticks can reduce nausea and vomiting in patients receiving chemotherapy as part of their stem cell transplant treatment. The main questions it aims to answer are: * Can aromatherapy inhaler sticks be practically used by patients undergoing stem cell transplant (feasibility)? * Do patients find aromatherapy inhaler sticks acceptable to use during their treatment? * How effective are aromatherapy inhaler sticks at reducing chemotherapy-induced nausea and vomiting? * What are patients' experiences when using aromatherapy during stem cell transplant? Researchers will compare patients using aromatherapy inhaler sticks with essential oils to patients using inhaler sticks with only jojoba oil (placebo) to see if the essential oils provide additional benefits for reducing nausea and vomiting. Participants will: * Use their assigned inhaler stick every four hours when awake and whenever they feel nauseous * Hold the inhaler stick a finger's length from their nostrils and inhale through one nostril at a time * Use the inhaler stick for no more than 5 minutes per session * Begin using the inhaler on the day of chemotherapy and continue until five days after chemotherapy completion (total of six days) * Receive standard care for nausea and vomiting alongside the inhaler stick * Complete study journals to record their experiences This is a single-blinded study, meaning participants will not know whether they received the aromatherapy or placebo inhaler stick.

Вмешательства

• Другое Aromatherapy inhaler
  Participants in the intervention group will receive inhalation therapy via an aromatherapy inhaler stick\*, on top of standard care. Participants will be instructed to use the inhaler stick every four hours when they are awake, and whenever they feel nauseous, by holding the inhaler stick a finger's length away from their nostrils and inhaling through one nostril at a time. Each inhaler administration should not last more than 5 minutes. Participants will commence using the inhaler stick on the
• Другое Aromatherapy inhaler (placebo)
  Participants in the control group will receive the placebo intervention in addition to standard care. They will be provided with an identical aromatherapy inhaler stick infused solely with jojoba oil. Jojoba oil, primarily used as a carrier oil for dilution, has littleto- no scent and no known therapeutic or anxiolytic effects when inhaled.

Первичные конечные точки

• Recruitment Rate [Срок оценки: From commencement of study (Day 1) to the end of treatment (Day 6)]
• Retention Rate [Срок оценки: From commencement of study (Day 1) to the end of treatment (Day 6)]
• Adherence rate [Срок оценки: From commencement of study (Day 1) to the end of treatment (Day 6)]
• Patient-reported satisfaction [Срок оценки: From commencement of study (Day 1) to the end of treatment (Day 6)]
• Perceptions and Overall Experience [Срок оценки: From commencement of study (Day 1) to the end of treatment (Day 6)]

Вторичные конечные точки (5)

• Severity of Nausea [Срок оценки: From commencement of study (Day 1) to the end of treatment (Day 6)]
• Frequency of Vomiting [Срок оценки: From commencement of study (Day 1) to the end of treatment (Day 6)]
• Use of Rescue Anti-Emetics [Срок оценки: From commencement of study (Day 1) to the end of treatment (Day 6)]
• Oral Intake [Срок оценки: From commencement of study (Day 1) to end of treatment (Day 6)]
• Grading of Chemotherapy-Induced Nausea and Vomiting (CINV) [Срок оценки: From commencement of study (Day 1) to end of treatment (Day 6)]

Критерии участия

Критерии включения

• At least 21 years and older
• Able to provide informed consent
• Admitted for autologous stem cell transplant receiving melphalan conditioning chemotherapy regime
• Willing to have interviews audio-recorded

Критерии исключения

• Currently using essential oils of any form (e.g. diffuser, topical application,
• Known sensitivity/ allergy to essential oils
• Any olfactory impairments (i.e. conditions that impair or alter sense of smell - for example, allergic rhinitis, chronic lung disease, blocked nose)

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 · 1 центр

• Singapore General Hospital — Singapore

Идентификаторы

NCT: NCT07209501 · 2024-3551 · 2024AMII-Aug03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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