- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07273825
The Effect of Geranium Essential Oil Aromatherapy on Fatigue and Sleep Quality in Patients Undergoing Hemodialysis
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.
Study Overview
Status
Conditions
Intervention / Treatment
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:
- evaluate the effect of geranium essential oil aromatherapy on fatigue levels in hemodialysis patients;
- assess the effect of the intervention on sleep quality;
- 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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Centre Java
-
Sukoharjo, Centre Java, Indonesia, 57169
- Faculty of Health Sciences, Universitas Muhammadiyah Surakarta
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: 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.
|
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.
Other Names:
|
|
Experimental: 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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Fatigue Score (FACIT-F Fatigue Scale)
Time Frame: Baseline (pre-intervention) and after each intervention phase (up to 30 days).
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Sleep Quality Score (Pittsburgh Sleep Quality Index - PSQI)
Time Frame: Baseline (pre-intervention) and after each intervention phase (up to 30 days)
|
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which evaluates subjective sleep quality, sleep latency, sleep duration, disturbances, use of sleep medication, and daytime dysfunction.
Higher scores indicate poorer sleep quality.
Assessments will be conducted before and after each intervention and placebo phase.
|
Baseline (pre-intervention) and after each intervention phase (up to 30 days)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Nervous System Diseases
- Mental Disorders
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Sleep Wake Disorders
- Renal Insufficiency
- Sleep Disorders, Intrinsic
- Dyssomnias
- Renal Insufficiency, Chronic
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Fatigue
- Sleep Initiation and Maintenance Disorders
- Kidney Failure, Chronic
- Therapeutics
- Mind-Body Therapies
- Complementary Therapies
- Psychotherapy
- Behavioral Disciplines and Activities
- Sensory Art Therapies
- Phytotherapy
- Aromatherapy
Other Study ID Numbers
- UMuhammadiyahSurakarta
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Fatigue
-
National Taiwan Sport UniversityGrape King Bio Ltd.CompletedEffect of Lactobacillus Plantarum GKK1 Supplementation on Anti-fatigue Health Effects (GKK1-Fatigue)Muscle Fatigue | Sports Performance | Exercise-Induced Fatigue | Fatigue RecoveryTaiwan
-
Bakulev Scientific Center of Cardiovascular SurgeryFoundation for the Support of Physical Culture and Sports BECOME A CHAMPION; Autonomous Non-Profit organization of additional education sports school BECOME A CHAMPIONRecruitingEfficacy, Self | Fatigue, Mental | Fatigue; Muscle, Heart | Fatigue; CombatRussian Federation
-
University of Southern MississippiEnrolling by invitationFatigue, Mental | Fatigue; Muscle, HeartUnited States
-
Akdeniz UniversityCompletedExercise-Induced Fatigue | Forearm Muscle FatigueTurkey (Türkiye)
-
Universita di VeronaUniversity of Southern CaliforniaCompletedDiet, Healthy | Fasting | Fatigue, Mental | Fatigue; Muscle, HeartItaly
-
Istinye UniversityRecruitingMental Fatigue | Muscular FatigueTurkey (Türkiye)
-
Chengdu Sport UniversityNot yet recruiting
-
University of ZurichCompletedVocal FatigueSwitzerland
-
KU LeuvenCompleted
-
Société des Produits Nestlé (SPN)Maastricht University Medical CenterCompleted
Clinical Trials on Placebo Aromatherapy (Non-Geranium Neutral Oil)
-
Universitas Muhammadiyah SurakartaCompletedCancer | Chemotherapy-Induced Nausea and Vomiting (CINV)Indonesia
-
Universitas Muhammadiyah SurakartaCompletedCancer | Chemotherapy Side Effects | Chemotherapy Induced Pain | Blood Pressure Changes in Cancer PatientsIndonesia
-
National University Hospital, SingaporeCompletedCataract | Surgery | Preoperative Anxiety | Vitrectomy | AromatherapySingapore
-
San Gallicano Dermatological Institute IRCCSCompletedMelanoma | Preoperative Anxiety | Non-Melanoma Skin Cancer | pT1aItaly
-
Tokat Gaziosmanpasa UniversityCompleted
-
Mayo ClinicNational Cancer Institute (NCI)CompletedHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | Nasal VestibulitisUnited States
-
University of Dublin, Trinity CollegeSt. James's Hospital, IrelandEnrolling by invitationWellbeing | Stress | RelaxationIreland
-
University of Sao PauloActive, not recruitingLabor Pain and AnxietyBrazil
-
The University of Texas Health Science Center at...University HealthEnrolling by invitationNausea | Suffering, PhysicalUnited States
-
TC Erciyes UniversityThe Scientific and Technological Research Council of TurkeyCompleted