Aromatherapy (Geranium Essential Oil)NCT07273825
The Effect of Geranium Essential Oil Aromatherapy on Fatigue and Sleep Quality in Patients Undergoing Hemodialysis
A study testing Geranium Aromatherapy in people with Aromatherapy (Geranium Essential Oil) and Chronic Kidney Disease on Hemodialysis, run by Universitas Muhammadiyah Surakarta at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Aromatherapy (Geranium Essential Oil), Chronic Kidney Disease on Hemodialysis, End Stage Renal Disease (ESRD)
- What is being tested?
- Geranium Aromatherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Faculty of Health Sciences, Universitas Muhammadiyah Surakarta
Sukoharjo, Centre Java, 57169
About this study
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.
Read more
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.
Read the 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
- Conditions
- Aromatherapy (Geranium Essential Oil), Chronic Kidney Disease on Hemodialysis, End Stage Renal Disease (ESRD), Fatigue, Poor Sleep Quality, Aromatherapy
- Being tested
- Placebo Aromatherapy (Non-Geranium Neutral Oil), Geranium Aromatherapy
- Keywords
- Aromatherapy, Geranium Essential Oil, Fatigue, Hemodialysis, Sleep Quality
- Medical subject headings
- Kidney Failure, Chronic, Fatigue, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Aromatherapy (Non-Geranium Neutral Oil)Other
Also called Neutral Aromatherapy Placebo
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 AromatherapyOther
Also called Geranium Essential Oil (GEO) 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Geranium Aromatherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Baseline (pre-intervention) and after each intervention phase (up to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start1 Jan 2025
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aromatherapy (Geranium Essential Oil)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Muhammadiyah Surakarta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fahrun Nur Rosyid, Universitas Muhammadiyah Surakarta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273825
- Sponsor's protocol ID
- UMuhammadiyahSurakarta
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the dataset contains sensitive clinical information from hemodialysis patients and cannot be sufficiently de-identified to ensure participant privacy. Only aggregated results will be made available through publications.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Geranium Essential Oil Aromatherapy on Fatigue and Sleep Quality in Patients Undergoing Hemodialysis
- ClinicalTrials.gov ID
- NCT07273825
- Acronym / sponsor ID
- UMuhammadiyahSurakarta
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Universitas Muhammadiyah SurakartaUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Placebo comparator | Other: Placebo Aromatherapy (Non-Geranium Neutral Oil)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. |
| Geranium Essential Oil Aromatherapy Arm | Experimental | Other: Geranium AromatherapyParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo Aromatherapy (Non-Geranium Neutral Oil)Also: Neutral Aromatherapy PlaceboThe 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 | Control Arm |
| Geranium AromatherapyAlso: Geranium Essential Oil (GEO) AromatherapyGeranium 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 | Geranium Essential Oil Aromatherapy Arm |
Primary outcome
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.
1 secondary outcome
Change in Sleep Quality Score (Pittsburgh Sleep Quality Index - PSQI)
Time frame: Baseline (pre-intervention) and after each intervention phase (up to 30 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the dataset contains sensitive clinical information from hemodialysis patients and cannot be sufficiently de-identified to ensure participant privacy. Only aggregated results will be made available through publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geranium Aromatherapy in people with Aromatherapy (Geranium Essential Oil) and Chronic Kidney Disease on Hemodialysis, run by Universitas Muhammadiyah Surakarta at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fatigue Score (FACIT-F Fatigue Scale) (time frame: Baseline (pre-intervention) and after each intervention phase (up to 30 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.