MedDataX Logo

Effect of Geranium Inhalation Aromatherapy on Pain and Blood Pressure in Cancer Patients Undergoing Chemotherapy

NCT ID: NCT07292844

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2022-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Chemotherapy Induced Pain Blood Pressure Changes in Cancer Patients Chemotherapy Side Effects

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Blood Pressure Cancer Chemotherapy Geranium Aromatherapy Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants were randomly assigned into two parallel groups (geranium aromatherapy vs. control) with no crossover during the study period
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Geranium Inhalation Aromatherapy

Intervention Type OTHER

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.

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Geranium Inhalation Aromatherapy

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Geranium Essential Oil Inhalation Aromatherapy with Geranium Oil

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Cancer patients undergoing intravenous chemotherapy (regimen 1 / series 1)
2. Age less than 65 years
3. Body Mass Index (BMI) between 18.5 and 22.9 kg/m².
4. Willing to participate and able to provide informed consent.

Exlusion:

1. Patients with conditions affecting the sense of smell (e.g., severe nasal obstruction or anosmia).
2. Patients with known allergies to essential oils or plant-based aromatherapy products.
3. Patients experiencing acute medical emergencies or unstable hemodynamic conditions during chemotherapy.
4. Patients who withdraw consent at any stage of the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universitas Muhammadiyah Surakarta

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fahrun Nur Rosyid

Head of Quality Assurance Group

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

FIK UMS

Role: PRINCIPAL_INVESTIGATOR

Universitas Muhammadiyah Surakarta

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

RSUD Dr. Moewardi Surakarta

Surakarta, Centre Java, Indonesia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Indonesia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UMS-GERANIUM-RCT2022

Identifier Type: -

Identifier Source: org_study_id