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

NCT ID: NCT07273825

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-09-30

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.

Detailed Description

Chronic kidney disease continues to increase worldwide and represents a major contributor to global morbidity and mortality. Hemodialysis is a primary treatment modality for replacing impaired renal function; however, the procedure is associated with various complications, including fatigue and sleep disturbances. Fatigue is one of the most prevalent symptoms among hemodialysis patients, with reported rates ranging from 60% to 97%. It can arise from multiple factors, including anemia, duration of hemodialysis, nutritional status, comorbidities, and uremic neuropathy. Persistent fatigue negatively impacts physical functioning, emotional wellbeing, social interaction, and overall quality of life.

Sleep disturbances are also frequently experienced by patients undergoing hemodialysis. Poor sleep quality may worsen fatigue, impair daytime functioning, and contribute to psychological distress. Given the complex and chronic nature of these symptoms, non-pharmacological interventions are increasingly explored to support symptom management.

Aromatherapy represents one complementary approach that has shown promising effects in managing fatigue and sleep problems. Geranium essential oil contains biologically active compounds-such as geraniol, citronellol, and other terpenoid alcohols-that exhibit relaxing, anti-inflammatory, and analgesic effects. When inhaled, aromatic molecules stimulate olfactory receptors, triggering neural signaling to the limbic system, which plays a key role in emotional regulation, stress response, hormonal balance, and sleep cycles. This mechanism suggests potential therapeutic value for reducing fatigue and improving sleep.

Previous studies have indicated that aromatherapy can benefit hemodialysis patients by reducing fatigue, anxiety, and sleep disturbances, though evidence specifically regarding geranium essential oil remains limited. Therefore, this study aims to generate robust clinical data on the effectiveness of geranium aromatherapy in this population.

A randomized cross-over design will be used, involving 90 hemodialysis patients recruited from multiple dialysis centers. All participants will serve as both control and intervention subjects at different phases of the study, minimizing variability across individuals. Fatigue will be measured using the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F), which evaluates physical and mental exhaustion affecting daily life. Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI), assessing multiple components of sleep behavior. Data analysis will include paired t-test, independent t-test, and Chi-Square test with a significance level of p < 0.05.

This study aims to:

1. evaluate the effect of geranium essential oil aromatherapy on fatigue levels in hemodialysis patients;

2. assess the effect of the intervention on sleep quality;

3. provide scientific justification for the use of geranium essential oil as a complementary and integrative therapy in hemodialysis care.

Planned outputs include publication in a reputable international journal, development of a book chapter, intellectual property registration, community health education activities, and undergraduate research theses. The overall goal is to contribute meaningful evidence for safe and effective complementary therapies derived from natural Indonesian plant products to enhance the quality of life of patients undergoing hemodialysis

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control Arm

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.

Group Type: PLACEBO_COMPARATOR

Placebo Aromatherapy (Non-Geranium Neutral Oil)

Intervention Type: 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.

Geranium Essential Oil Aromatherapy Arm

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.

Group Type: EXPERIMENTAL

Geranium Aromatherapy

Intervention Type: 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.

Interventions

Placebo Aromatherapy (Non-Geranium Neutral Oil)

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.

Intervention Type: OTHER

Geranium Aromatherapy

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.

Intervention Type: OTHER

Other Intervention Names

Neutral Aromatherapy Placebo; Geranium Essential Oil (GEO) Aromatherapy

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitas Muhammadiyah Surakarta

OTHER

Sponsor Role: lead

Responsible Party

Fahrun Nur Rosyid

Head of Quality Assurance Group

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Health Sciences, Universitas Muhammadiyah Surakarta

Sukoharjo, Centre Java, Indonesia

Countries

Indonesia

Other Identifiers

UMuhammadiyahSurakarta

Identifier Type: -

Identifier Source: org_study_id