The Effect of Lavender Oil Applied Via Inhalation on Headache and Anxiety Level

NCT07299617 | Completed

• 1 other identifier: ERU-SBF-GDH-01
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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) 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.

Conditions

Hemodialysis Patients

Keywords

Hemodialysis; Pain; Anxiety; Lavender oil; Nursing

Outcome Measures

Primary Outcomes (1)

• 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 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).

  Measured at the 2nd and 4th hours of dialysis sessions throughout the 4-week study period.

• Trait Anxiety Level (STAI-T)

  At the beginning of the study (baseline) and at the end of the 4th week.

Study Arms (2)

Pure Lavender Oil Inhalation Group

OTHER

Participants assigned to the lavender oil inhalation intervention.

Other: Lavender Oil Inhalation

Control group patients.

OTHER

A total of 32 control group patients (standard hemodialysis care)

Other: Standard Hemodialysis Care

Interventions

Lavender Oil Inhalation OTHER

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.

Also known as: Aromatherapy with Lavender Oil, Lavandula angustifolia inhalation

Pure Lavender Oil Inhalation Group

Standard Hemodialysis Care OTHER

Participants in the control group receive only routine hemodialysis treatment. No additional aromatherapeutic intervention or inhalation is administered during the study period.

Control group patients.

Eligibility Criteria

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

You may qualify if:

• 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,
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Goknur Demir Hacimusalar: lead

Study Sites (1)

Erciyes Univercity

Kayseri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

Aromatherapy; lavender oil

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; 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: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Phd

Model Details: 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.

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: December 23, 2025
• Study Start: December 1, 2018
• Primary Completion: January 30, 2019
• Study Completion: August 30, 2019
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 6 months after publication of the study results, and will be available for 10 years.
• Access Criteria: The data will be available upon request by contacting the corresponding author via email. The requester must sign a data access agreement.

Locations

TU (1)