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Completed

NCT Number: NCT06874777

Implantable Cardioverter Defibrillator (ICD) Patients and Inhalation Aromatherapy

The effective management of anxiety and fatigue, which lead to negative physical, social, and psychological impacts and increase treatment costs in individuals with implanted cardioverter-defibrillators (ICD), is of great importance. Complementary and integrative therapy (CIT) methods offer a non-pharmacological, easy-to-apply, and safe intervention alternative for nurses and patients experiencing these symptoms. This study was conducted to investigate the effect of lavender oil aromatherapy, applied by inhalation for two minutes with two drops before bedtime for one month, on anxiety and fatigue levels in individuals with ICD, in a randomized controlled single-blind study design. A total of 86 patients with ICD implantation were included in the study, and 43 patients were randomly assigned to the intervention and control groups. The intervention group received lavender aromatherapy for two minutes with two drops of lavender oil inhaled before bedtime every night for one month, in addition to their routine treatment. The control group received only routine treatment. The study was conducted after obtaining the necessary ethical approval, institutional permission, and informed consent from the patients. The Patient Diagnosis Form, Piper Fatigue Scale (PFS), Spielberger State-Trait Anxiety Inventory Short Form (STAI-SF and STAI-TF), and Visual Analogue Scale (VAS) for Fatigue were used in data collection. The data were analyzed using the Statistical Package for Social Sciences (SPSS) 25.0 and G*Power program. A value of p<0.05 was considered statistically significant in comparisons.

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Key information

Conditions

Implantable Cardioverter Defibrillator (ICD) Anxiety Anxiety Disorders Aromatherapy Fatigue Fatigue Symptom Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Turkish Ministry of Health, Adana City Training and Research Hospital

Adana, Yüreğir, 4522, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Individuals who were willing to participate in the study,
  • aged between 18 and 65 years,
  • with no physical or mental health issues that would hinder communication,
  • had an ICD implanted at least 6 months ago,
  • had a battery life of at least 3 months,
  • had a fatigue level of 3 or higher on the Visual Analog Scale for Fatigue (VAS-F),
  • had an EF of 40% or higher,
  • and were visiting the cardiology outpatient clinic for ICD control

Exclusion criteria

  • Individuals receiving anxiolytic or antidepressant treatment,
  • those with respiratory system diseases (such as asthma, bronchitis, or chronic obstructive pulmonary disease), 19,231 characters left
  • those with a known sensitivity to the essential oils used, and individuals with an olfactory impairment

Treatment and study plan

Aromatherapy group

Other

It is known that aromatherapy is used in symptom management in chronic diseases. When the literature is examined, it is seen that aromatherapy application is effective in relieving anxiety and fatigue in cardiovascular diseases. Currently, there is no symptom management method other than pharmacological treatment that is widely used or recommended by health professionals for ICD patients. The literature review reveals that there is no study examining the effect of lavender oil aromatherapy in relieving anxiety and fatigue in individuals with ICD implantation. In this context, the aim of this study is to determine the effect of aromatherapy applied by inhaling two drops for two minutes before going to bed for one month on anxiety and fatigue levels in individuals with ICD implantation.

Other names: Aromatherapy inhalation

Primary outcomes

  1. Change severity of fatigue

    Time frame: Within 1 month and at the end of the 1st month

    2-point changes in the Visual Analoque Scale Fatigue Scale (VAS-F). VAS is known to be used for assessing the severity of fatigue symptoms. The scale consists of a 10 cm ruler, with one end labeled as 0 - "I do not feel fatigued" and the other end labeled as 10 - "I feel extremely fatigued." A score of 0-3 indicates "mild fatigue," 4-6 indicates "moderate fatigue," and 7-10 indicates "severe fatigue." In the study, interviewers explained to the patients that the 0-10 scale represents the severity of fatigue, and they were asked to mark the point corresponding to their fatigue level with a pen.

  2. Change level of fatigue

    Time frame: Within 1 month and at the end of the 1st month

    1-point change in the average score of the Piper Fatigue Scale.The scale is a 5-point Likert-type scale. As the score obtained from the scale increases, the level of fatigue also increases.

Other outcomes

  1. Change level of anxiety

    Time frame: Within 1 month and at the end of the 1st month

    2-point changes in the average score of the State anxiety inventory Short Form 2-point changes in the average score of the Trait anxiety inventory Short Form. The inventory consists of a total of 10 items. The first 5 items measure state anxiety, while the second 5 items assess trait anxiety. In the first 5 items, which evaluate how a person feels "at the moment," participants are expected to choose one of the following options: (1) "not at all," (2) "sometimes," (3) "very much," and (4) "completely." Similarly, in the second 5 items, which also assess how a person feels "at the moment," participants are expected to select one of the following responses: (1) "almost never," (2) "sometimes," (3) "most of the time," and (4) "almost always." Individuals who score 10 or above on the State Anxiety Inventory-Short Form (SAI-SF) and 14 or above on the Trait Anxiety Inventory-Short Form (TAI-SF) are considered clinically anxious.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

Effect of Aromatherapy Applied by Inhalation on Anxiety and Fatigue Levels in Individuals With Implantable Cardioverter Defibrillator (ICD)

Acronym: ICD

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Mar 13, 2025
Registry last updated
Mar 13, 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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