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.

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.

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.

Deidentified individual participant data (IPD) will be shared. Supporting documents such as the study protocol and clinical study report will also be available

Beginning 6 months after publication of the study results, and will be available for 10 years.

The data will be available upon request by contacting the corresponding author via email. The requester must sign a data access agreement.