Implantable Cardioverter Defibrillator (ICD) Patients and Inhalation Aromatherapy (ICD)

March 7, 2025 updated by: Sebiha Aktaş Us, TC Erciyes University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Yüreğir
      • Adana, Yüreğir, Turkey, 4522
        • Turkish Ministry of Health, Adana City Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: aromatherapy group
Each participant in the intervention group was provided with lavender oil inhalation in addition to their routine treatments within the framework of the application protocol. This was administered by two surveyors, instructing the patients to apply it themselves. The method involved placing two drops of lavender oil on a gauze pad, holding it 5 cm below the nose for two minutes, followed by three deep breaths. This procedure was carried out for one month.
Other: Aromatherapy group
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
No Intervention: control group
The control group was provided with routine treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 1 month and at the end of the 1st month
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.
Within 1 month and at the end of the 1st month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 1 month and at the end of the 1st month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Collaborators

The Scientific and Technological Research Council of Türkiye (TÜBİTAK)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2023

Primary Completion (Actual)

November 29, 2024

Study Completion (Actual)

February 15, 2025

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

March 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 7, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Erciyes

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Those are private personal informations

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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