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

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.

Study Overview

• Status: Completed
• Conditions: Hemodialysis Patients
• Intervention / Treatment: Other: Lavender Oil Inhalation; Other: Standard Hemodialysis Care

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Kayseri, Turkey (Türkiye)
    • Erciyes Univercity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Pure Lavender Oil Inhalation Group; Participants assigned to the lavender oil inhalation intervention.	Other: Lavender Oil 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.; Other Names: Aromatherapy with Lavender Oil; Lavandula angustifolia inhalation
Other: Control group patients.; A total of 32 control group patients (standard hemodialysis care)	Other: Standard Hemodialysis Care; Participants in the control group receive only routine hemodialysis treatment. No additional aromatherapeutic intervention or inhalation is administered during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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.	At the beginning of the study (baseline) and at the end of the 4th week.

Collaborators and Investigators

• Sponsor: Goknur Demir Hacimusalar

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): January 30, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: September 22, 2025
• First Submitted That Met QC Criteria: December 20, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Nursing; Hemodialysis; Lavender oil
• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Anxiety Disorders; Therapeutics; Mind-Body Therapies; Complementary Therapies; Psychotherapy; Behavioral Disciplines and Activities; Sensory Art Therapies; Phytotherapy; Aromatherapy; lavender oil
• Other Study ID Numbers: ERU-SBF-GDH-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data (IPD) will be shared. Supporting documents such as the study protocol and clinical study report will also be available
• IPD Sharing Time Frame: Beginning 6 months after publication of the study results, and will be available for 10 years.
• IPD Sharing Access Criteria: The data will be available upon request by contacting the corresponding author via email. The requester must sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No