Implantable Cardioverter Defibrillator (ICD) Patients and Inhalation Aromatherapy

Not Applicable

Completed

• Conditions: Implantable Cardioverter Defibrillator (ICD); Aromatherapy; Anxiety; Fatigue Symptom

• Registration Number: NCT06874777
• Lead Sponsor: TC Erciyes University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-08
• Primary Completion: 2024-11-29
• Study Completion: 2025-02-15
• Study First Submitted: 2025-02-27
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-07
• Last Update Submitted: 2025-03-07
• Study First Posted: 2025-03-13
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change severity of fatigue	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.
Change level of fatigue	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.

Trial Locations

Locations (1)

Turkish Ministry of Health, Adana City Training and Research Hospital; 🇹🇷 Adana, Yüreğir, Turkey