Effect of Geranium Inhalation Aromatherapy on Reducing Pain and Blood Pressure Among Indonesian Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial
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 Pain Intensity (Visual Analog Scale - VAS)
研究概览
简要总结
This randomized controlled trial aims to examine the effect of geranium inhalation aromatherapy on pain and blood pressure among Indonesian cancer patients undergoing intravenous chemotherapy. A total of 90 participants under the age of 65 with normal BMI will be enrolled and randomly assigned to either an intervention group or a control group. The intervention group will receive geranium essential oil inhalation using three drops applied to cotton and inhaled for 15 minutes during chemotherapy sessions, while the control group will receive usual care without aromatherapy. Pain intensity will be measured using the Visual Analog Scale (VAS), and blood pressure will be recorded using a standard digital blood pressure monitor before and after the intervention. This study aims to evaluate whether geranium aromatherapy can be feasibly implemented as a complementary supportive therapy during chemotherapy. Study Started Date after January 18, 2017
详细描述
Cancer patients undergoing chemotherapy frequently experience a range of physical and psychological side effects, including pain, fatigue, nausea, sleep disturbances, and fluctuations in blood pressure. Complementary approaches such as aromatherapy are increasingly explored as supportive interventions due to their accessibility, safety, and low cost. Geranium essential oil contains bioactive components such as geraniol and citronellol, which have been noted for potential analgesic, anti-inflammatory, and relaxing properties. This study utilizes a randomized controlled trial design to evaluate the effect of geranium inhalation aromatherapy on pain and blood pressure among cancer patients undergoing chemotherapy at a public hospital in Surakarta, Indonesia. Ethical approval was obtained from the Health Research Ethics Committee of Dr. Moewardi General Hospital prior to participant recruitment.
Ninety patients meeting the inclusion criteria (age < 65 years, normal BMI, undergoing chemotherapy regimen 1, and providing informed consent) will be selected using simple random sampling. Participants will be randomly assigned into two equal groups: an intervention group receiving geranium inhalation aromatherapy and a control group receiving standard care without aromatherapy. The intervention consists of applying three drops of geranium essential oil onto cotton, which patients will inhale for 15 minutes during their chemotherapy sessions, conducted twice per month. Pre- and post-intervention assessments will include demographic characteristics, pain intensity measured using the Visual Analog Scale (VAS), and blood pressure recorded using an OMRON digital blood pressure monitor. Data analysis will involve paired t-tests, independent t-tests, and chi-square tests, with statistical significance set at p < 0.05. This study is designed to explore potential physiological mechanisms related to aromatherapy, which may include olfactory system stimulation, relaxation responses, modulation of endogenous hormones, and autonomic regulation. The study also acknowledges possible limitations such as sample size, intervention duration, and the absence of biomarker assessments.
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
- •Cancer patients undergoing intravenous chemotherapy (regimen 1 / series 1)
- •Age less than 65 years
- •Body Mass Index (BMI) between 18.5 and 22.9 kg/m².
- •Willing to participate and able to provide informed consent.
- •Patients with conditions affecting the sense of smell (e.g., severe nasal obstruction or anosmia).
- •Patients with known allergies to essential oils or plant-based aromatherapy products.
- •Patients experiencing acute medical emergencies or unstable hemodynamic conditions during chemotherapy.
- •Patients who withdraw consent at any stage of the study.
排除标准
- 未提供
结局指标
主要结局
Change in Pain Intensity (Visual Analog Scale - VAS)
时间窗: Measured immediately before and after each aromatherapy session (single-session pre-post measurement).
Pain intensity was measured using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain). Measurements were conducted immediately before the intervention and immediately after the 15-minute aromatherapy exposure during chemotherapy. The primary outcome is the change in VAS score from pre- to post-intervention.
次要结局
- Change in Systolic Blood Pressure(Measured immediately before and after each aromatherapy session.)
研究者
Fahrun Nur Rosyid
Head of Quality Assurance Group
Universitas Muhammadiyah Surakarta