NCT06874777

Implantable Cardioverter Defibrillator (ICD) Patients and Inhalation Aromatherapy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: TC Erciyes University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Implantable Cardioverter Defibrillator (ICD)
• Aromatherapy
• Anxiety
• Fatigue Symptom

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-09-08
• Primary completion: 2024-11-29
• Completion: 2025-02-15
• First posted: 2025-03-13
• Last updated: 2025-03-13

Locations

1 site across 1 country: Turkey (Türkiye)