- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07721168
THE EFFECT OF AROMATHERAPY FOOT BATHS ON CANCER PATIENTS (AROMA-FOOTBATH)
July 20, 2026 updated by: Semra Gündoğdu, Ankara Yildirim Beyazıt University
THE EFFECT OF AROMATHERAPY FOOT BATHS ON PAIN, SLEEP QUALITY, AND FATIGUE IN CANCER PATIENTS: A RANDOMIZED CONTROLLED TRIAL
The goal of this randomised clinical trial is to evaluate the effects of aromatherapy-infused foot baths on pain, sleep quality, and fatigue in cancer patients. The main question[s] it aims to answer are:
- Is an aromatherapy foot bath effective in reducing pain in cancer patients?
- Is an aromatherapy foot bath effective in improving sleep quality in cancer patients?
- Is an aromatherapy foot bath effective in reducing fatigue in cancer patients? The experimental group will receive a total of 5 sessions of aromatherapy foot baths, each lasting 20 minutes per day for 5 days, administered by the researcher. The control group will receive only routine care without any treatment. Before and after all treatments are completed, participants will be given and asked to complete the Hirai Cancer Fatigue Scale, the Pittsburgh Sleep Quality Index (PSQI), and the Numerical Pain Scale. The pain, fatigue, and sleep quality scores of the experimental and control groups will then be compared.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Erdal Ceylan
- Phone Number: +905362323599
- Email: erdalceylan@aybu.edu.tr
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients over 18 years of age,
- Conscious (Glasgow coma scale: 15 points)
- No diagnosis of mental illness
- No respiratory distress
- No diagnosis of respiratory system disorder
- Patients who agree to participate in the study
Exclusion Criteria:
- Patients under 18 years of age,
- Patients with a Glasgow Coma Scale score below 15 points,
- Patients with a diagnosis of mental illness,
- Patients with respiratory distress,
- Patients with a diagnosis of respiratory system disease,
- Patients with hemiplegia or paraplegia,
- Patients who refused to participate in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Aromatherapy Group
The experimental group will receive a foot bath treatment containing aromatherapy.
|
The experimental group will receive a foot bath treatment containing aromatherapy for 5 days administered by the researcher.
A foot bath device will be used.
Lavender essential oil will be added to the water as aromatherapy.
Then, the researcher will administer a foot bath to the patient using this water.
|
|
No Intervention: Standard Care Group
The control group will not receive a foot bath containing aromatherapy.
They will only receive the routine care provided in the service.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hirai Cancer Fatigue Scale
Time Frame: Baseline and day 5
|
The scale has a minimum score of 15 and a maximum score of 75.
Higher scores indicate increased fatigue, while lower scores indicate decreased fatigue.
|
Baseline and day 5
|
|
Numerical Pain Scale
Time Frame: Baseline and day 5
|
Participants will be asked to rate the intensity of their pain on a scale of 0 (no pain) to 10 (most severe pain).
A higher score indicates increasing pain.
|
Baseline and day 5
|
|
Pittsburgh Sleep Quality Index
Time Frame: Baseline and day 5
|
The total score ranges from 0 to 21.
A total score higher than 5 indicates poor sleep quality.
|
Baseline and day 5
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Semra Gündoğdu, Ankara Yildirim Beyazıt University
- Study Director: Erdal Ceylan, Ankara Yildirim Beyazıt University
- Study Chair: Ahmet Özgen Yıldırım, Ankara Etlik City Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
July 14, 2026
First Submitted That Met QC Criteria
July 20, 2026
First Posted (Actual)
July 22, 2026
Study Record Updates
Last Update Posted (Actual)
July 22, 2026
Last Update Submitted That Met QC Criteria
July 20, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Sleep Wake Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Fatigue
- Sleep Initiation and Maintenance Disorders
- Therapeutics
- Mind-Body Therapies
- Complementary Therapies
- Psychotherapy
- Behavioral Disciplines and Activities
- Sensory Art Therapies
- Phytotherapy
- Aromatherapy
Other Study ID Numbers
- 2026-02/77
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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