- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07292844
Effect of Geranium Inhalation Aromatherapy on Pain and Blood Pressure in Cancer Patients Undergoing Chemotherapy
Effect of Geranium Inhalation Aromatherapy on Reducing Pain and Blood Pressure Among Indonesian Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Centre Java
-
Surakarta, Centre Java, Indonesia, 57162
- RSUD Dr. Moewardi Surakarta
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion:
- 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.
Exlusion:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Geranium Inhalation Aromatherapy
Participants in this arm received geranium inhalation aromatherapy during their chemotherapy session.
Three drops of geranium essential oil were placed on a piece of cotton and inhaled for 15 minutes during chemotherapy, administered twice per month.
Pain and blood pressure were assessed before and after the intervention
|
Participants received inhalation aromatherapy using geranium essential oil during their chemotherapy session.
Three drops of geranium essential oil were placed on a piece of cotton positioned near the patient to allow continuous inhalation.
The aromatherapy was administered for 15 minutes during chemotherapy and given twice per month.
Pain intensity (VAS) and blood pressure were measured before and after each session.
The control group received usual care without aromatherapy.
Other Names:
|
|
No Intervention: Usual Care / No Aromatherapy
Participants in this arm received standard chemotherapy care without any aromatherapy intervention.
They underwent the same assessment procedures as the intervention group, including pre- and post-treatment measurements of pain and blood pressure, but no essential oil was administered
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pain Intensity (Visual Analog Scale - VAS)
Time Frame: 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.
|
Measured immediately before and after each aromatherapy session (single-session pre-post measurement).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Systolic Blood Pressure
Time Frame: Measured immediately before and after each aromatherapy session.
|
Diastolic blood pressure was measured using the OMRON HEM-7156AT blood pressure device before and after the 15-minute aromatherapy exposure.
The outcome is defined as the pre-post change in diastolic blood pressure
|
Measured immediately before and after each aromatherapy session.
|
Collaborators and Investigators
Investigators
- Principal Investigator: FIK UMS, Universitas Muhammadiyah Surakarta
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UMS-GERANIUM-RCT2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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