Effects of Lavender Essential Oil in Patients With Chronic Heart Failure

Chronic Heart Failure Clinical Trial

Official title:

Effects of Lavender Essential Oil on Sleep Quality, Anxiety, and Fatigue in Patients With Chronic Heart Failure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05862350
• Other study ID #: XJTU1AF2022LSK-400
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 10, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: October 2022
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Jingwen Hu, Master
• Phone: 008602985383801
• Email: jingwenhu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of the trial is to study the effects of lavender essential oil on sleep quality, anxiety, and fatigue in patients with chronic heart failure. The main questions it may answer are

1. effects of lavender essential oil on sleep quality

2. effects of lavender essential oil on anxiety

3. effects of lavender essential oil on fatigue

Patients will be randomly divided into experimental and control groups, the control group will inhale essential coconut oil, and the experimental group will inhale lavender essential oil for four weeks. At baseline, on the 7th day, and 28th day, the sleep quality, anxiety, and fatigue will be evaluated.

Description:

Heart failure (HF)， a severe manifestation or advanced stage of various cardiac diseases, may seriously affect patients' quality of life because repeated hospitalizations lead to changes in work and living environment, changes in roles, economic burdens, sexual dysfunction, limitations of social life, and worries about maintaining life. Patients are often accompanied by mental problems such as anxiety, depression, fatigue, and sleep disorders, so their quality of life is low.

Currently, the treatment of CHF is mainly to improve physical symptoms and control complications. However, insufficient attention is drawn to mental and psychological problems such as anxiety, sleep disorders, and fatigue associated with CHF patients.

Patients with anxiety and sleep disturbances are generally treated with antipsychotic and sedative-hypnotic drugs. Although effective, this method also creates dependencies and tolerability with the long-term application. So in recent years, complementary and alternative medicine is a novel adjunctive therapy, including aromatherapy, and traditional medicine, which can improve the patient's health and maintain a calm inner peace.

The commonly used lavender essential oil (Lavandula angustifolia) is the least toxic and allergenic of all aromatic oils. The main components of lavender are linalool and linalool acetate, which act as sedative, anti-nociceptive, and antispasmodic by reducing sympathetic nerve activity and stimulating the parasympathetic nervous system activity. Aromatherapy using lavender essential oil has been widely used in patients with cancer, postpartum depression, pregnant women, blood purification, acute coronary syndrome, myocardial infarction, and quasi-coronary angiography. Studies have shown that aromatherapy using lavender essential oil can relieve anxiety and depression, reduce fatigue, and improve sleep quality, and it has not been found to cause associated adverse events and complications. It showed good safety, while the use of lavender essential oil in patients with CHF has been less studied.

This study intends to use aromatherapy for CHF patients to observe the effects of lavender essential oil inhalation on sleep quality, anxiety, and fatigue in CHF patients, in order to provide a new care method for CHF patients with all-round mental and physical self-management and improve the long-term quality of life of CHF patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Met the diagnostic criteria of heart failure:cardiac function grade ?-?, disease duration =6 months.

• Blood pressure =90/60mmH, heart rate =60 times/min.

• No malignant arrhythmia, no need for oxygen or mechanical ventilation.

• Pittsburgh sleep quality (PSQI) score > 5, State-trait anxiety scale (STAI) score 21-59.

• No nasal diseases, normal sense of smell.

• Normal hearing and language expression, able to communicate, volunteer to participate in this study.

Exclusion Criteria:

• Pregnant women.

• Suffering from physical pain diseases or combined with tumors and other serious diseases of the system

• A history of mental illness, the use of psychiatric or sedative hypnotic drugs within 1 month.

• Allergic constitution, allergic to lavender essential oil or coconut oil, suffering from allergic rhinitis, eczema, asthma and other respiratory diseases.

• Declined to participate in this study.

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Other:
• aromatherapy inhalation with lavender essential oil
patients in the experimental group will receive aromatherapy inhalation by 4 drops of 50% lavender essential oil,which is diluted with coconut essential oil, on the cotton chip in the diffuser clip for 8 hours each night during sleep
• aromatherapy inhalation with coconut essential oil.
patients in the experimental group will receive aromatherapy inhalation by 4 drops of 100% coconut essential oil on the cotton chip in the diffuser clip for 8 hours each night during sleep

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

References & Publications (10)

Cavanagh HM, Wilkinson JM. Biological activities of lavender essential oil. Phytother Res. 2002 Jun;16(4):301-8. doi: 10.1002/ptr.1103. — View Citation

Cheraghbeigi N, Modarresi M, Rezaei M, Khatony A. Comparing the effects of massage and aromatherapy massage with lavender oil on sleep quality of cardiac patients: A randomized controlled trial. Complement Ther Clin Pract. 2019 May;35:253-258. doi: 10.1016/j.ctcp.2019.03.005. Epub 2019 Mar 8. — View Citation

Dos Reis Lucena L, Dos Santos-Junior JG, Tufik S, Hachul H. Lavender essential oil on postmenopausal women with insomnia: Double-blind randomized trial. Complement Ther Med. 2021 Jun;59:102726. doi: 10.1016/j.ctim.2021.102726. Epub 2021 Apr 24. — View Citation

Drexler H, Coats AJ. Explaining fatigue in congestive heart failure. Annu Rev Med. 1996;47:241-56. doi: 10.1146/annurev.med.47.1.241. — View Citation

Easton K, Coventry P, Lovell K, Carter LA, Deaton C. Prevalence and Measurement of Anxiety in Samples of Patients With Heart Failure: Meta-analysis. J Cardiovasc Nurs. 2016 Jul-Aug;31(4):367-79. doi: 10.1097/JCN.0000000000000265. — View Citation

Kessing D, Denollet J, Widdershoven J, Kupper N. Fatigue and self-care in patients with chronic heart failure. Eur J Cardiovasc Nurs. 2016 Aug;15(5):337-44. doi: 10.1177/1474515115575834. Epub 2015 Feb 25. — View Citation

Lee J, Hur MH. The Effects of Aroma Essential Oil Inhalation on Stress, Pain, and Sleep Quality in Laparoscopic Cholecystectomy Patients: A Randomized Controlled Trial. Asian Nurs Res (Korean Soc Nurs Sci). 2022 Feb;16(1):1-8. doi: 10.1016/j.anr.2021.11.002. Epub 2021 Dec 24. — View Citation

Moradi K, Ashtarian H, Danzima NY, Saeedi H, Bijan B, Akbari F, Mohammadi MM. Essential Oil from Citrus aurantium Alleviates Anxiety of Patients Undergoing Coronary Angiography: A Single-Blind, Randomized Controlled Trial. Chin J Integr Med. 2021 Mar;27(3):177-182. doi: 10.1007/s11655-020-3266-5. Epub 2020 Jun 22. — View Citation

Shammas RL, Marks CE, Broadwater G, Le E, Glener AD, Sergesketter AR, Cason RW, Rezak KM, Phillips BT, Hollenbeck ST. The Effect of Lavender Oil on Perioperative Pain, Anxiety, Depression, and Sleep after Microvascular Breast Reconstruction: A Prospective, Single-Blinded, Randomized, Controlled Trial. J Reconstr Microsurg. 2021 Jul;37(6):530-540. doi: 10.1055/s-0041-1724465. Epub 2021 Feb 6. — View Citation

Steinhorn DM, Din J, Johnson A. Healing, spirituality and integrative medicine. Ann Palliat Med. 2017 Jul;6(3):237-247. doi: 10.21037/apm.2017.05.01. Epub 2017 May 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Pittsburgh Sleep Quality Index	The Pittsburgh Sleep Quality Index assesses sleep quality, with scores ranging from 0 to 21. Higher scores mean poorer sleep quality.	at base line,7th day, 14th day, 28th day
Primary	Change of State-trait anxiety inventory	The State-trait anxiety inventory is used to assess state anxiety and trait anxiety on a scale from 20 to 80, with higher scores meaning more severe anxiety.	at base line,7th day, 14th day, 28th day
Primary	Change of the Fatigue Assessment Scale	The Fatigue Assessment Scale assesses fatigue levels on a scale of 10 to 50, with higher scores meaning more fatigue.	at base line,7th day, 14th day, 28th day