Hemodialysis PatientsNCT07299617
The Effect of Lavender Oil Applied Via Inhalation on Headache and Anxiety Level
A study testing Lavender Oil Inhalation and Standard Hemodialysis Care in people with Hemodialysis Patients, run by Goknur Demir Hacimusalar at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study aims to determine the effect of pure lavender oil inhalation on headache severity and anxiety levels in hemodialysis (HD) patients. The research, conducted in three dialysis centers, included a total of 62 patients who were randomly assigned to either an intervention group (n=30)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Patients
- What is being tested?
- Lavender Oil Inhalation and Standard Hemodialysis Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2018to 30 Aug 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those who are 18 years of age and over,
- Able to understand and communicate in Turkish,
- Receiving hemodialysis treatment three times a week for at least 3 months,
- Not pregnant and not planning a pregnancy,
- Having a pain intensity of 3 or more on the Visual Analog Scale, measured twice,
- Headache that develops during dialysis,
Show all 10Show fewer
- Headache worsening throughout the dialysis session,
- Headache resolves spontaneously within 72 hours after dialysis ends,
- No visual or hearing impairment,
- Individuals who could take painkillers when they had pain were included in the study
Who cannot join
- Those who are allergic to or uncomfortable with the smell of lavender oil,
- Having any obstacle to smell,
- Having a history of asthma,
- Individuals who used other complementary integrative medicine methods during the treatment process were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Lavender Oil Applied Via Inhalation On Headache And Anxiety Level in Individuals Undergoing Hemodialysis Treatment
This randomized controlled study aims to determine the effect of pure lavender oil inhalation on headache severity and anxiety levels in hemodialysis (HD) patients. The research, conducted in three dialysis centers, included a total of 62 patients who were randomly assigned to either an intervention group (n=30) receiving lavender oil inhalation or a control group (n=32) receiving standard care. Data were collected using the Visual Analogue Scale (VAS) for headache severity and the State-Trait Anxiety Inventory (STAI) for anxiety levels.
Read the detailed description
Background: Pain, particularly headaches, is a common symptom in hemodialysis (HD) patients that can significantly impact their quality of life. This study investigates the potential therapeutic effect of an integrative medicine approach-lavender oil inhalation-as a non-pharmacological intervention.
Study Design: This is a multi-center, prospective, randomized, open-label, parallel-assignment controlled study. The study population consists of 62 adult hemodialysis patients from three dialysis centers in a city center in Turkey. Participants were enrolled based on specific inclusion criteria, including experiencing headaches during HD sessions.
Interventions: Patients were randomly assigned to one of two groups. The intervention group (n=30) received pure lavender oil inhalation for 5 minutes, three times a week, at the 2nd hour of their HD session, for a duration of one month. The control group (n=32) continued to receive only their standard hemodialysis care without any additional intervention.
Data Collection and Outcome Measures: Data were collected using a patient introduction form to gather demographic information. For a period of four weeks, headache severity was measured using the Visual Analogue Scale (VAS) immediately before, two hours after the start, and at the end of each dialysis session. Anxiety levels were assessed using the State-Trait Anxiety Inventory (STAI), with the STAI-S applied at the 2nd and 4th hours of dialysis and the STAI-T at the beginning and end of the four-week study period.
- Conditions
- Hemodialysis Patients
- Being tested
- Lavender Oil Inhalation, Standard Hemodialysis Care
- Keywords
- Hemodialysis, Pain, Anxiety, Lavender oil, Nursing
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavender Oil InhalationOther
Also called Aromatherapy with Lavender Oil, Lavandula angustifolia inhalation
Participants receive pure medical lavender oil (Lavandula angustifolia) with a certificate of analysis. During the 2nd hour of the dialysis session, 3 drops of lavender oil are applied to a 6x6 cm gauze pad. Patients are instructed to inhale the scent from a distance of 5 cm for 5 minutes. This procedure is performed 3 times a week for 4 weeks, totaling 12 sessions. The dosage adjustment and application are performed by the researchers.
Standard Hemodialysis CareOther
Participants in the control group receive only routine hemodialysis treatment. No additional aromatherapeutic intervention or inhalation is administered during the study period.
| Study group | Role | What they receive |
|---|---|---|
| Pure Lavender Oil Inhalation Group | Other | Participants assigned to the lavender oil inhalation intervention. Receives: Other: Lavender Oil Inhalation |
| Control group patients. | Other | A total of 32 control group patients (standard hemodialysis care) Receives: Other: Standard Hemodialysis Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Severity measured by Visual Analog Scale (VAS).
Headache severity is measured using a 10-unit Visual Analog Scale (VAS) where "0" represents no pain and "10" represents the most severe pain possible. A lower score indicates a reduction in headache intensity
Measured: Measured 3 times during each hemodialysis session (immediately before, 2 hours after start, and at the end of dialysis) over a period of 4 weeks (total of 12 sessions).
Secondary outcomes (2)
State Anxiety Levels measured by State Anxiety Inventory (STAI-S).
This inventory consists of 20 items measuring how the individual feels at a given moment. Scores range from 20 to 80, with higher scores indicating higher levels of anxiety.
Measured: Measured at the 2nd and 4th hours of dialysis sessions throughout the 4-week study period.
Trait Anxiety Level (STAI-T)
Measured by the State-Trait Anxiety Inventory - Trait subscale (20 items). Scores range from 20 to 80, where higher scores indicate higher general levels of anxiety.
Measured: At the beginning of the study (baseline) and at the end of the 4th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start1 Dec 2018
- Primary completion30 Jan 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis PatientsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It was conducted as a randomized controlled study to determine the effect of pure lavender oil applied by inhalation for 5 minutes, 3 times a week, for a month, on the severity of headaches that develop during dialysis and the level of state-trait anxiety in individuals receiving hemodialysis treatment.
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goknur Demir Hacimusalar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Goknur Demir Hacimusalar, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299617
- Sponsor's protocol ID
- ERU-SBF-GDH-01
- Status last verified
- Dec 2025
- First submitted
- 22 Sep 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data (IPD) will be shared. Supporting documents such as the study protocol and clinical study report will also be available
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lavender Oil Applied Via Inhalation On Headache And Anxiety Level in Individuals Undergoing Hemodialysis Treatment
- ClinicalTrials.gov ID
- NCT07299617
- Acronym / sponsor ID
- ERU-SBF-GDH-01
- Conditions
- Hemodialysis Patients
- Keywords
- Hemodialysis, Pain, Anxiety, Lavender oil, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Goknur Demir HacimusalarUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 23 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.
This randomized controlled study aims to determine the effect of pure lavender oil inhalation on headache severity and anxiety levels in hemodialysis (HD) patients. The research, conducted in three dialysis centers, included a total of 62 patients who were randomly assigned to either an intervention group (n=30) receiving lavender oil inhalation or a control group (n=32) receiving standard care. Data were collected using the Visual Analogue Scale (VAS) for headache severity and the State-Trait Anxiety Inventory (STAI) for anxiety levels.
Detailed description
Background: Pain, particularly headaches, is a common symptom in hemodialysis (HD) patients that can significantly impact their quality of life. This study investigates the potential therapeutic effect of an integrative medicine approach-lavender oil inhalation-as a non-pharmacological intervention.
Study Design: This is a multi-center, prospective, randomized, open-label, parallel-assignment controlled study. The study population consists of 62 adult hemodialysis patients from three dialysis centers in a city center in Turkey. Participants were enrolled based on specific inclusion criteria, including experiencing headaches during HD sessions.
Interventions: Patients were randomly assigned to one of two groups. The intervention group (n=30) received pure lavender oil inhalation for 5 minutes, three times a week, at the 2nd hour of their HD session, for a duration of one month. The control group (n=32) continued to receive only their standard hemodialysis care without any additional intervention.
Data Collection and Outcome Measures: Data were collected using a patient introduction form to gather demographic information. For a period of four weeks, headache severity was measured using the Visual Analogue Scale (VAS) immediately before, two hours after the start, and at the end of each dialysis session. Anxiety levels were assessed using the State-Trait Anxiety Inventory (STAI), with the STAI-S applied at the 2nd and 4th hours of dialysis and the STAI-T at the beginning and end of the four-week study period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- It was conducted as a randomized controlled study to determine the effect of pure lavender oil applied by inhalation for 5 minutes, 3 times a week, for a month, on the severity of headaches that develop during dialysis and the level of state-trait anxiety in individuals receiving hemodialysis treatment.
| Arm | Type | Receives |
|---|---|---|
| Pure Lavender Oil Inhalation Group | Other | Other: Lavender Oil InhalationParticipants assigned to the lavender oil inhalation intervention. |
| Control group patients. | Other | Other: Standard Hemodialysis CareA total of 32 control group patients (standard hemodialysis care) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Those who are 18 years of age and over,
Key exclusion criteria (4 listed)
- Those who are allergic to or uncomfortable with the smell of lavender oil,
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 |
|---|---|---|
| Lavender Oil InhalationAlso: Aromatherapy with Lavender Oil, Lavandula angustifolia inhalationParticipants receive pure medical lavender oil (Lavandula angustifolia) with a certificate of analysis. During the 2nd hour of the dialysis session, 3 drops of lavender oil are applied to a 6x6 cm gauze pad. Patients are instructed to inhale the scent from a distance of 5 cm for 5 minutes. This procedure is performed 3 times a week for 4 weeks, totaling 12 sessions. The dosage adjustment and application are performed by the researchers. | Other | Pure Lavender Oil Inhalation Group |
| Standard Hemodialysis CareParticipants in the control group receive only routine hemodialysis treatment. No additional aromatherapeutic intervention or inhalation is administered during the study period. | Other | Control group patients. |
Primary outcome
Headache Severity measured by Visual Analog Scale (VAS).
Time frame: Measured 3 times during each hemodialysis session (immediately before, 2 hours after start, and at the end of dialysis) over a period of 4 weeks (total of 12 sessions).
Headache severity is measured using a 10-unit Visual Analog Scale (VAS) where "0" represents no pain and "10" represents the most severe pain possible. A lower score indicates a reduction in headache intensity
2 secondary outcomes
State Anxiety Levels measured by State Anxiety Inventory (STAI-S).
Time frame: Measured at the 2nd and 4th hours of dialysis sessions throughout the 4-week study period.
Trait Anxiety Level (STAI-T)
Time frame: At the beginning of the study (baseline) and at the end of the 4th week.
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 23 Dec 2025.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data (IPD) will be shared. Supporting documents such as the study protocol and clinical study report will also be available
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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 Lavender Oil Inhalation and Standard Hemodialysis Care in people with Hemodialysis Patients, run by Goknur Demir Hacimusalar at 1 site in Turkey (Türkiye).
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 10 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 23 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 Turkey (Türkiye). 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. 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?
Headache Severity measured by Visual Analog Scale (VAS). (time frame: Measured 3 times during each hemodialysis session (immediately before, 2 hours after start, and at the end of dialysis) over a period of 4 weeks (total of 12 sessions).). 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 23 Dec 2025.