Geranium Inhalation Aromatherapy: An Alternative Therapy to Alleviate Nausea & Vomiting in Cancer Patients Undergoing Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in Nausea and Vomiting Score (INVR)
研究概览
简要总结
Chemotherapy-induced nausea and vomiting (CINV) remain among the most distressing side effects experienced by cancer patients and can significantly affect treatment tolerance and quality of life. Geranium essential oil has been proposed as a complementary, non-pharmacological therapy that may help reduce nausea and vomiting through its calming and antiemetic properties.
This randomized controlled trial aims to evaluate the potential effectiveness of geranium inhalation aromatherapy in reducing nausea and vomiting among cancer patients undergoing chemotherapy. Ninety participants undergoing intravenous chemotherapy will be enrolled and randomly assigned to either the geranium aromatherapy group or the control group. The intervention group will receive inhalation of geranium essential oil, while the control group will receive no aromatherapy.Nausea and vomiting will be measured using the validated Index of Nausea, Vomiting, and Retching (INVR) before chemotherapy and 12 hours afterward. This study is designed to explore whether geranium inhalation aromatherapy may serve as a supportive complementary therapy to enhance comfort and overall quality of life for patients undergoing chemotherapy.
详细描述
Chemotherapy is a primary treatment modality for many types of cancer but is frequently accompanied by adverse effects, particularly nausea and vomiting. These symptoms are triggered by complex interactions between neurotransmitters and receptors in both the gastrointestinal and central nervous systems. Although antiemetic medications have improved over the years, many patients continue to experience discomfort that negatively affects their quality of life. Complementary therapies such as aromatherapy are increasingly explored as supportive approaches to help alleviate these symptoms. Geranium essential oil (Pelargonium graveolens) possesses calming, anti-inflammatory, and potential antiemetic properties. Inhalation aromatherapy is thought to reduce nausea by stimulating olfactory pathways associated with relaxation and autonomic regulation. This study aims to investigate the potential benefit of geranium inhalation aromatherapy as an adjunct to standard chemotherapy care. This randomized controlled trial (RCT) involves 90 cancer patients undergoing intravenous chemotherapy at a public hospital in Surakarta, Indonesia. Participants are selected through simple random sampling. Inclusion criteria include patients aged under 65 years, with a BMI of 18.5-22.9 kg/m², receiving chemotherapy regimen 1, and willing to provide informed consent. Participants will be randomized into two groups: a treatment group receiving geranium inhalation aromatherapy and a control group receiving no aromatherapy. Baseline demographic and clinical characteristics-including age, gender, education level, occupation, body mass index, duration of illness, cancer stage, hemoglobin levels, leukocyte and platelet counts, kidney function, liver function, and chemotherapy status-will be recorded to ensure comparability between groups. Geranium aromatherapy will be administered through inhalation, a method known to deliver rapid olfactory stimulation and promote relaxation. Nausea and vomiting will be assessed using the Index of Nausea, Vomiting, and Retching (INVR), a reliable and widely used instrument for evaluating chemotherapy-related gastrointestinal symptoms. Measurements will be collected at baseline and 12 hours after chemotherapy. This study is expected to provide additional insight into the feasibility, safety, and potential role of aromatherapy-specifically geranium essential oil-in supporting the management of chemotherapy-induced nausea and vomiting as part of a holistic approach to cancer care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with cancer.
- •Currently undergoing intravenous chemotherapy regimen
- •Aged under 65 years.
- •Body Mass Index (BMI) between 18.5 and 22.9 kg/m².
- •Able and willing to provide informed consent.
- •Able to communicate and follow study instructions.
排除标准
- •Known allergy or sensitivity to essential oils or fragrances
结局指标
主要结局
Change in Nausea and Vomiting Score (INVR)
时间窗: Baseline to 12 hours after chemotherapy
The primary outcome is the change in nausea, vomiting, and retching severity measured using the Index of Nausea, Vomiting, and Retching (INVR). INVR scores are collected before chemotherapy (baseline) and 12 hours after chemotherapy. The measure evaluates the effectiveness of geranium inhalation aromatherapy in reducing chemotherapy-induced nausea and vomiting.
次要结局
- Incidence of Chemotherapy-Induced Nausea and Vomiting (CINV)(12 hours after chemotherapy)
研究者
Fahrun Nur Rosyid
Head of Quality Assurance Group
Universitas Muhammadiyah Surakarta
