Clinical trial NCT06874777: Implantable Cardioverter Defibrillator (ICD) Patients and Inhalation Aromatherapy
Official title: Effect of Aromatherapy Applied by Inhalation on Anxiety and Fatigue Levels in Individuals With Implantable Cardioverter Defibrillator (ICD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implantable Cardioverter Defibrillator (ICD)
Aromatherapy
Anxiety
Fatigue Symptom
Keywords: Aromatherapy
anxiety
implantable cardioverter defibrillator (ICD)
nursing
fatigue
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Türkiye (TÜBİTAK)
First posted: 2025-03-13
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change severity of fatigue
timeFrame: Within 1 month and at the end of the 1st month
measure: Change level of fatigue
timeFrame: Within 1 month and at the end of the 1st month
Secondary outcomes:
Other outcomes:
measure: Change level of anxiety
timeFrame: Within 1 month and at the end of the 1st month
Locations:
city: Adana
country: Turkey
facility: Turkish Ministry of Health, Adana City Training and Research Hospital
state: Yüreğir
Study officials:
References:
citation: Forman J, Baumbusch J, Jackson H, Lindenberg J, Shook A, Bashir J. Exploring the patients' experiences of living with a subcutaneous implantable cardioverter defibrillator. Eur J Cardiovasc Nurs. 2018 Dec;17(8):698-706. doi: 10.1177/1474515118777419. Epub 2018 May 18.
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citation: Gong M, Dong H, Tang Y, Huang W, Lu F. Effects of aromatherapy on anxiety: A meta-analysis of randomized controlled trials. J Affect Disord. 2020 Sep 1;274:1028-1040. doi: 10.1016/j.jad.2020.05.118. Epub 2020 May 26.
citation: Hassanzadeh, M., Farsi, Z., & Sajadi, S. A. (2021). Comparison of the effect of Sedamin and aromatherapy with Lavender on fatigue severity of patients with heart failure: A three arm randomized controlled trial. Journal of Herbal Medicine, 30, 100514. https://doi.org/10.1016/j.hermed.2021.100514
citation: Karadag E, Samancioglu S, Ozden D, Bakir E. Effects of aromatherapy on sleep quality and anxiety of patients. Nurs Crit Care. 2017 Mar;22(2):105-112. doi: 10.1111/nicc.12198. Epub 2015 Jul 27.
citation: Liu L, Liu R, Zhang L, Tang Y, Fan C. The effect of aromatherapy on patients with acute coronary syndrome: A systematic review and meta-analysis. Complement Ther Clin Pract. 2024 Nov;57:101882. doi: 10.1016/j.ctcp.2024.101882. Epub 2024 Jul 6.
citation: Lopes, L. de S., Bündchen, D., Modesto, F. C., Quintão, M., Chermont, S., Cavalcanti, A. C. D., & Mesquita, E. T. (2020). Aromatherapy in Patients with Cardiovascular Diseases: A Systematic Review. International Journal of Cardiovascular Sciences. https://doi.org/10.36660/ijcs.20190086