- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07292831
Geranium Inhalation Aromatherapy for Reducing Nausea and Vomiting in Cancer Patients Undergoing Chemotherapy
Geranium Inhalation Aromatherapy: An Alternative Therapy to Alleviate Nausea & Vomiting in Cancer Patients Undergoing Chemotherapy
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Centre Java
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Surakarta, Centre Java, Indonesia, 57126
- RSUD Dr. Moewardi Surakarta
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed with cancer.
- Currently undergoing intravenous chemotherapy regimen 1.
- 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.
Exclusion Criteria:
Known allergy or sensitivity to essential oils or fragrances
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 Aromatherapy
Participants in this arm received geranium essential oil inhalation aromatherapy during chemotherapy.
The aromatherapy was administered by allowing patients to inhale geranium essential oil through a controlled inhalation method.
This intervention was provided during the chemotherapy session, and nausea/vomiting levels were assessed before and 12 hours after chemotherapy using the Index of Nausea, Vomiting, and Retching (INVR).
|
Participants received inhalation aromatherapy using geranium essential oil (Pelargonium graveolens).
The essential oil was administered through controlled inhalation during the chemotherapy session.
Patients inhaled the aroma directly, allowing olfactory stimulation intended to reduce nausea and vomiting.
The intervention was applied according to a standardized protocol, and nausea/vomiting were assessed before and 12 hours after chemotherapy using the Index of Nausea, Vomiting, and Retching (INVR).
Other Names:
|
|
No Intervention: Control (No Aromatherapy)
Participants in this arm did not receive any aromatherapy or additional supportive intervention.
They underwent chemotherapy according to the standard hospital protocol.
Nausea and vomiting were assessed at baseline and 12 hours after chemotherapy using the Index of Nausea, Vomiting, and Retching (INVR).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Nausea and Vomiting Score (INVR)
Time Frame: 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.
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Baseline to 12 hours after chemotherapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Chemotherapy-Induced Nausea and Vomiting (CINV)
Time Frame: 12 hours after chemotherapy
|
The secondary outcome is the proportion of participants experiencing nausea and vomiting after chemotherapy, assessed using INVR categorical scores.
This measure compares differences in symptom incidence between the geranium aromatherapy group and the control group
|
12 hours after chemotherapy
|
Collaborators and Investigators
Investigators
- Principal Investigator: Faculty of Health Sciences 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-RCT2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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