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
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recruitment Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Control Group
Participants in the control group will receive the placebo intervention in addition to standard care. Participants 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 little to- no scent and no known therapeutic or anxiolytic effects when inhaled. This ensures that any potential benefits observed in the intervention group can be attributed to the active essential oil blends rather than the inhalation process itself.
干预措施: Aromatherapy inhaler (placebo) (Other)
Intervention group
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 administration should not last more than 5 minutes. Participants will commence using the inhaler stick on the day of chemotherapy, until five days after the completion of chemotherapy (a total of six days).
干预措施: Aromatherapy inhaler (Other)
结局指标
主要结局
Recruitment Rate
时间窗: From commencement of study (Day 1) to the end of treatment (Day 6)
Percentage of eligible patients who consent to join the study will be measured to evaluate the feasibility of using inhalation aromatherapy to reduce chemotherapy-induced nausea and vomiting (CINV) for patients undergoing haematopoietic stem cell transplant (HSCT)
Retention Rate
时间窗: From commencement of study (Day 1) to the end of treatment (Day 6)
Percentage of participants who complete the study will be measured to evaluate the feasibility of using inhalation aromatherapy to reduce chemotherapy-induced nausea and vomiting (CINV) for patients undergoing haematopoietic stem cell transplant (HSCT)
Adherence rate
时间窗: From commencement of study (Day 1) to the end of treatment (Day 6)
Percentage of participants in the intervention group who use the inhaler stick as instructed measured to evaluate the feasibility of using inhalation aromatherapy to reduce chemotherapy-induced nausea and vomiting (CINV) for patients undergoing haematopoietic stem cell transplant (HSCT)
Patient-reported satisfaction
时间窗: From commencement of study (Day 1) to the end of treatment (Day 6)
Measured through Likert-scale items at the end of the study to evaluate the acceptability of using inhalation aromatherapy to reduce chemotherapy-induced nausea and vomiting (CINV) for patients undergoing hematopoietic stem cell transplant (HSCT). The Feasibility of intervention Likert-scale and the Acceptability of intervention Liker-scale will be used. The Likert-scale consist of a rating of 1- 5 where 1 is strongly disagree and 5 is strongly agree and to be rated by participants.
Perceptions and Overall Experience
时间窗: From commencement of study (Day 1) to the end of treatment (Day 6)
Qualitative insights from semi-structured interviews on ease of use, perceived helpfulness and overall experience to evaluate acceptability of using inhalation aromatherapy to reduce chemotherapy-induced nausea and vomiting (CINV) for patients undergoing haematopoietic stem cell transplant (HSCT)
Recruitment Rate
时间窗: From commencement of study (Day 1) to the end of treatment (Day 6)
Percentage of eligible patients who consent to join the study will be measured to evaluate the feasibility of using inhalation aromatherapy to reduce chemotherapy-induced nausea and vomiting (CINV) for patients undergoing haematopoietic stem cell transplant (HSCT)
Retention Rate
时间窗: From commencement of study (Day 1) to the end of treatment (Day 6)
Percentage of participants who complete the study will be measured to evaluate the feasibility of using inhalation aromatherapy to reduce chemotherapy-induced nausea and vomiting (CINV) for patients undergoing haematopoietic stem cell transplant (HSCT)
Adherence rate
时间窗: From commencement of study (Day 1) to the end of treatment (Day 6)
Percentage of participants in the intervention group who use the inhaler stick as instructed measured to evaluate the feasibility of using inhalation aromatherapy to reduce chemotherapy-induced nausea and vomiting (CINV) for patients undergoing haematopoietic stem cell transplant (HSCT)
Patient-reported satisfaction
时间窗: From commencement of study (Day 1) to the end of treatment (Day 6)
Measured through Likert-scale items at the end of the study to evaluate the acceptability of using inhalation aromatherapy to reduce chemotherapy-induced nausea and vomiting (CINV) for patients undergoing hematopoietic stem cell transplant (HSCT). The Feasibility of intervention Likert-scale and the Acceptability of intervention Liker-scale will be used. The Likert-scale consist of a rating of 1- 5 where 1 is strongly disagree and 5 is strongly agree and to be rated by participants.
Perceptions and Overall Experience
时间窗: From commencement of study (Day 1) to the end of treatment (Day 6)
Qualitative insights from semi-structured interviews on ease of use, perceived helpfulness and overall experience to evaluate acceptability of using inhalation aromatherapy to reduce chemotherapy-induced nausea and vomiting (CINV) for patients undergoing haematopoietic stem cell transplant (HSCT)
次要结局
- Severity of Nausea(From commencement of study (Day 1) to the end of treatment (Day 6))
- Frequency of Vomiting(From commencement of study (Day 1) to the end of treatment (Day 6))
- Use of Rescue Anti-Emetics(From commencement of study (Day 1) to the end of treatment (Day 6))
- Oral Intake(From commencement of study (Day 1) to end of treatment (Day 6))
- Grading of Chemotherapy-Induced Nausea and Vomiting (CINV)(From commencement of study (Day 1) to end of treatment (Day 6))