Implantable Cardioverter Defibrillator (ICD) Patients and Inhalation Aromatherapy

TC Erciyes University

Status: Completed

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

Treatments: Other: Aromatherapy group

Study type: Interventional

Funder types: Other

Identifiers

NCT06874777

Erciyes

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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86 participants in 2 patient groups

aromatherapy group

Experimental group

Description:

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.

Treatment:

Other: Aromatherapy group

control group

No Intervention group

Description:

The control group was provided with routine treatment