NCT06874777: ICD

Implantable Cardioverter Defibrillator (ICD) Patients and Inhalation Aromatherapy

Completed NA Last updated 13 March 2025

What this trial tests

NA trial testing Aromatherapy group in Implantable Cardioverter Defibrillator (ICD) in 86 participants. Completed in 15 February 2025.

Timeline

8 September 2023

Primary endpoint
29 November 2024

15 February 2025

Quick facts

Lead sponsor	TC Erciyes University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	health services research
Enrollment	86
Start date	8 September 2023
Primary completion	29 November 2024
Estimated completion	15 February 2025
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Aromatherapy group

Conditions studied

• Implantable Cardioverter Defibrillator (ICD) — all drugs for Implantable Cardioverter Defibrillator (ICD) →
• Aromatherapy — all drugs for Aromatherapy →
• Anxiety — all drugs for Anxiety →
• Fatigue Symptom — all drugs for Fatigue Symptom →

Sponsor

TC Erciyes University

Who can join

Adults 18 to 65, any sex, with Implantable Cardioverter Defibrillator (ICD) or Aromatherapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Symptom Experiences and Coping Strategies in Turkish Patients with Implantable Cardioverter-Defibrillators: A Cross-Sectional Study Based on Interviews.
   Us SA, Taşcı S. · · 2025 · PMID 41516990 · DOI 10.3390/healthcare14010059