NCT07292831

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

9 months

First QC Date

November 23, 2025

Last Update Submit

December 5, 2025

Conditions

Keywords

CancerChemotherapyGeranium AromatherapyNauseaVomiting

Outcome Measures

Primary Outcomes (1)

  • Change in Nausea and Vomiting Score (INVR)

    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.

    Baseline to 12 hours after chemotherapy

Secondary Outcomes (1)

  • Incidence of Chemotherapy-Induced Nausea and Vomiting (CINV)

    12 hours after chemotherapy

Study Arms (2)

Geranium Aromatherapy

EXPERIMENTAL

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).

Other: Geranium Inhalation Aromatherapy

Control (No Aromatherapy)

NO INTERVENTION

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).

Interventions

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).

Also known as: Geranium Essential Oil, Aromatherapy with Geranium Oil
Geranium Aromatherapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Known allergy or sensitivity to essential oils or fragrances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RSUD Dr. Moewardi Surakarta

Surakarta, Centre Java, 57126, Indonesia

Location

MeSH Terms

Conditions

VomitingNeoplasmsNausea

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPhytotherapySensory Art TherapiesPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Faculty of Health Sciences FIK UMS

    Universitas Muhammadiyah Surakarta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to one of two parallel groups: a geranium aromatherapy group and a control group without aromatherapy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Quality Assurance Group

Study Record Dates

First Submitted

November 23, 2025

First Posted

December 18, 2025

Study Start

January 1, 2024

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

December 18, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations