Evaluating the Feasibility and Acceptability of Inhalation Aromatherapy for Patients Undergoing Autologous Haematopoietic Stem Cell Transplant (HSCT)
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: Aromatherapy inhaler, Aromatherapy inhaler (placebo).
- Who it may be relevant to
- Registry conditions: Chemotherapy-Induced Nausea and Vomiting (CINV). Basic parameters: 21 years — 99 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 →
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Official title
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
Overview
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.
Interventions
- Other 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 - Other 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.
Primary outcome measures
- Recruitment Rate [Time frame: From commencement of study (Day 1) to the end of treatment (Day 6)]
- Retention Rate [Time frame: From commencement of study (Day 1) to the end of treatment (Day 6)]
- Adherence rate [Time frame: From commencement of study (Day 1) to the end of treatment (Day 6)]
- Patient-reported satisfaction [Time frame: From commencement of study (Day 1) to the end of treatment (Day 6)]
- Perceptions and Overall Experience [Time frame: From commencement of study (Day 1) to the end of treatment (Day 6)]
Secondary outcome measures (5)
- Severity of Nausea [Time frame: From commencement of study (Day 1) to the end of treatment (Day 6)]
- Frequency of Vomiting [Time frame: From commencement of study (Day 1) to the end of treatment (Day 6)]
- Use of Rescue Anti-Emetics [Time frame: From commencement of study (Day 1) to the end of treatment (Day 6)]
- Oral Intake [Time frame: From commencement of study (Day 1) to end of treatment (Day 6)]
- Grading of Chemotherapy-Induced Nausea and Vomiting (CINV) [Time frame: From commencement of study (Day 1) to end of treatment (Day 6)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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)
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 · 1 center
- Singapore General Hospital — Singapore
Identifiers
NCT: NCT07209501 · 2024-3551 · 2024AMII-Aug03