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NCT Number: NCT07299617

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

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.

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Key information

Conditions

Hemodialysis Patients Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes Univercity

Kayseri, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Aromatherapy with Lavender Oil, Lavandula angustifolia inhalation

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

    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.

  2. Trait Anxiety Level (STAI-T)

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

    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.

Sponsors and collaborators

Lead sponsor

Goknur Demir Hacimusalar

Other

Registry information

Official study title

The Effect of Lavender Oil Applied Via Inhalation On Headache And Anxiety Level in Individuals Undergoing Hemodialysis Treatment

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 23, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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