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AzTrials

Implantable Cardioverter Defibrillator (ICD)ICDNCT06874777

Implantable Cardioverter Defibrillator (ICD) Patients and Inhalation Aromatherapy

A study testing Aromatherapy group in people with Implantable Cardioverter Defibrillator (ICD) and Aromatherapy, run by TC Erciyes University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Aromatherapy group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteTurkey (Türkiye)
Study dates
8 Sep 2023to 15 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Turkish Ministry of Health, Adana City Training and Research Hospital

    Adana, Yüreğir, 4522

Other trials in Turkey (Türkiye)

About this study

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

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.

Being tested
Aromatherapy group
Keywords
Aromatherapy, anxiety, implantable cardioverter defibrillator (ICD), nursing, fatigue
Medical subject headings
Anxiety Disorders, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aromatherapy groupOther

    Also called Aromatherapy inhalation

    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.

Study groups in NCT06874777
Study groupRoleWhat they receive
aromatherapy groupExperimentalEach 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.
Receives: Other: Aromatherapy group
control groupNo interventionThe control group was provided with routine treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change severity of fatigue

    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.

    Measured: Within 1 month and at the end of the 1st month

  2. Change level of fatigue

    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.

    Measured: Within 1 month and at the end of the 1st month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2025
  2. Study start8 Sep 2023
  3. Primary completion29 Nov 2024
  4. Study completion15 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06874777
Sponsor's protocol ID
Erciyes
Acronym
ICD
Status last verified
Mar 2025
First submitted
27 Feb 2025
Last updated
13 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Those are private personal informations

Publications

  • 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.

    PubMed 29775072

  • AlMohammed HI, A Alanazi N, Maghrabi EF, A Alotaibi M. Role of Aromatherapy as a Natural Complementary and Alternative Therapy in Cardiovascular Disease: A Comprehensive Systematic Review. Evid Based Complement Alternat Med. 2022 May 20;2022:4543078. doi: 10.1155/2022/4543078. eCollection 2022.

    PubMed 35646155

  • 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.

    PubMed 32663929

  • 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

  • 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.

    PubMed 26211735

  • 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.

    PubMed 38976965

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Aromatherapy group in people with Implantable Cardioverter Defibrillator (ICD) and Aromatherapy, run by TC Erciyes University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change severity of fatigue (time frame: Within 1 month and at the end of the 1st month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06874777, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.

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