NCT07721168

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Aug 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Aug 2026Dec 2026

First Submitted

Initial submission to the registry

July 14, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 22, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

July 14, 2026

Last Update Submit

July 20, 2026

Conditions

Keywords

AromatherapyFoot bathPainFatigueSleep quality

Outcome Measures

Primary Outcomes (3)

  • Hirai Cancer Fatigue Scale

    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

    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

    The total score ranges from 0 to 21. A total score higher than 5 indicates poor sleep quality.

    Baseline and day 5

Study Arms (2)

Aromatherapy Group

EXPERIMENTAL

The experimental group will receive a foot bath treatment containing aromatherapy.

Other: Aromatherapy

Standard Care Group

NO INTERVENTION

The control group will not receive a foot bath containing aromatherapy. They will only receive the routine care provided in the service.

Interventions

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.

Aromatherapy Group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PainFatigueSleep Initiation and Maintenance Disorders

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPhytotherapySensory Art TherapiesPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Semra Gündoğdu

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR
  • Erdal Ceylan

    Ankara Yildirim Beyazıt University

    STUDY DIRECTOR
  • Ahmet Özgen Yıldırım

    Ankara Etlik City Hospital

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

July 14, 2026

First Posted

July 22, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

July 22, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share