The Effect of Geranium Essential Oil Aromatherapy on Fatigue and Sleep Quality in Patients Undergoing Hemodialysis

NCT07273825 | Completed DMC

• 1 other identifier: UMuhammadiyahSurakarta
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Hemodialysis is a life-sustaining therapy for individuals with chronic kidney disease; however, it is often accompanied by adverse effects such as fatigue and poor sleep quality. Fatigue is one of the most frequently reported symptoms among hemodialysis patients and can significantly impair daily functioning, psychosocial wellbeing, and overall quality of life. Sleep disturbances are also common and may further exacerbate physical and emotional stress. Aromatherapy using essential oils has been explored as a non-pharmacological intervention to reduce fatigue and improve sleep quality. Geranium essential oil contains active compounds such as geraniol, citronellol, and terpineol, which possess relaxing, anti-inflammatory, and analgesic properties. These characteristics indicate its potential to alleviate fatigue and promote better sleep. This study aims to evaluate the effect of geranium essential oil aromatherapy on fatigue and sleep quality in patients undergoing hemodialysis. The study employs a randomized cross-over design involving 90 participants who meet predetermined inclusion criteria. Fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F), and sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI). Assessments will be conducted before and after the intervention period. The findings of this study are expected to provide scientific evidence supporting the use of geranium essential oil aromatherapy as a safe, accessible complementary therapy that may help reduce fatigue and improve sleep quality among hemodialysis patients.

Conditions

Aromatherapy (Geranium Essential Oil); Chronic Kidney Disease on Hemodialysis; End Stage Renal Disease (ESRD); Fatigue; Poor Sleep Quality; Aromatherapy

Keywords

Aromatherapy; Geranium Essential Oil; Fatigue; Hemodialysis; Sleep Quality

Outcome Measures

Primary Outcomes (1)

• Change in Fatigue Score (FACIT-F Fatigue Scale)

  Fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale, consisting of 13 items rated on a 0-4 Likert scale. Total scores reflect fatigue severity, with lower scores indicating worse fatigue. Measurements will be taken before and after the intervention and placebo periods in the randomized cross-over design.

  Baseline (pre-intervention) and after each intervention phase (up to 30 days).

Secondary Outcomes (1)

• Change in Sleep Quality Score (Pittsburgh Sleep Quality Index - PSQI)

  Baseline (pre-intervention) and after each intervention phase (up to 30 days)

Study Arms (2)

Control Arm

PLACEBO COMPARATOR

Participants in this arm will receive placebo aromatherapy (odorless substance) during hemodialysis sessions. The placebo is administered in the same manner as the geranium essential oil aromatherapy to maintain consistency of procedures. No active essential oil components are present. Fatigue will be measured using the FACIT-F scale, and sleep quality will be evaluated using the Pittsburgh Sleep Quality Index (PSQI). After completing this phase, participants will cross over to the intervention arm according to the randomized sequence.

Other: Placebo Aromatherapy (Non-Geranium Neutral Oil)

Geranium Essential Oil Aromatherapy Arm

EXPERIMENTAL

Participants in this arm will receive geranium essential oil aromatherapy during hemodialysis sessions. The aromatherapy is administered through inhalation of geranium essential oil during the treatment period. Fatigue will be assessed using the FACIT-F scale and sleep quality will be measured using the PSQI before and after the intervention. After the intervention phase, participants will cross over to the control arm according to the randomized schedule.

Other: Geranium Aromatherapy

Interventions

Placebo Aromatherapy (Non-Geranium Neutral Oil) OTHER

The placebo aromatherapy uses a non-active neutral oil without geranium's aromatic compounds or therapeutic properties. The placebo oil has a mild scent designed to mimic the inhalation procedure without producing physiological effects. It is administered using the same method, duration, and frequency as the Geranium Essential Oil intervention to ensure blinding and maintain procedural consistency. This placebo serves as a comparison to evaluate the true effect of Geranium Essential Oil on fatigue and sleep quality in hemodialysis patients.

Also known as: Neutral Aromatherapy Placebo

Control Arm

Geranium Aromatherapy OTHER

Geranium Essential Oil aromatherapy is administered through inhalation to provide relaxation effects aimed at reducing fatigue and improving sleep quality in patients undergoing hemodialysis. Geranium oil contains active components such as citronellol, geraniol, and linalool, which exhibit anti-inflammatory, analgesic, antioxidant, and calming properties. In this study, the intervention is applied before and/or during hemodialysis sessions using a randomized cross-over design to compare its effects on fatigue and sleep quality.

Also known as: Geranium Essential Oil (GEO) Aromatherapy

Geranium Essential Oil Aromatherapy Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-65 years.
• Have no visual or hearing impairments.
• Provide informed consent to participate.
• Have undergone hemodialysis (HD) for at least 3 months.
• Regularly receive HD at the study site.
• Undergo HD at least 2 times per week. 'Experience moderate to severe fatigue.

You may not qualify if:

• Presence of respiratory disease.
• History of allergy to perfumes or fragrance products.
• Olfactory impairment (difficulty smelling).
• Use of other therapies for fatigue during the intervention period

Sponsors & Collaborators

• Universitas Muhammadiyah Surakarta: lead

Study Sites (1)

Faculty of Health Sciences, Universitas Muhammadiyah Surakarta

Sukoharjo, Centre Java, 57169, Indonesia

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Fatigue; Sleep Initiation and Maintenance Disorders

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Quality Assurance Group

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 10, 2025
• Study Start: January 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)