Effects of Lavender Essential Oil in Patients With Chronic Heart Failure

Sponsor

First Affiliated Hospital Xi'an Jiaotong University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05862350

Collaborator

(none)

Enrollment

Arms

5.7

Anticipated Duration (Months)

Study Details

Study Description

Brief 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

effects of lavender essential oil on sleep quality
effects of lavender essential oil on anxiety
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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Heart Failure	Other: aromatherapy inhalation with lavender essential oil Other: aromatherapy inhalation with coconut essential oil.	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 10, 2023

Anticipated Primary Completion Date :

Jul 30, 2023

Anticipated Study Completion Date :

Oct 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aromatherapy inhalation with lavender essential oil Patients in this group will receive aromatherapy inhalation with lavender essential oil for 28 days , and their sleep quality, anxiety and fatigue will be evaluated at baseline, the 7th day, and 28th day.	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
Placebo Comparator: Aromatherapy inhalation with coconut essential oil Patients in this group will receive aromatherapy inhalation with coconut essential oil for 28 days , and their sleep quality, anxiety and fatigue will be evaluated at baseline, the 7th day, and 28th day.	Other: 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

Arm

Intervention/Treatment

Experimental: Aromatherapy inhalation with lavender essential oil

Patients in this group will receive aromatherapy inhalation with lavender essential oil for 28 days , and their sleep quality, anxiety and fatigue will be evaluated at baseline, the 7th day, and 28th day.

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

Placebo Comparator: Aromatherapy inhalation with coconut essential oil

Patients in this group will receive aromatherapy inhalation with coconut essential oil for 28 days , and their sleep quality, anxiety and fatigue will be evaluated at baseline, the 7th day, and 28th day.

Other: 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

Outcome Measures

Primary Outcome Measures

Change of Pittsburgh Sleep Quality Index [at base line,7th day, 14th day, 28th day]
The Pittsburgh Sleep Quality Index assesses sleep quality, with scores ranging from 0 to 21. Higher scores mean poorer sleep quality.
Change of State-trait anxiety inventory [at base line,7th day, 14th day, 28th day]
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.
Change of the Fatigue Assessment Scale [at base line,7th day, 14th day, 28th day]
The Fatigue Assessment Scale assesses fatigue levels on a scale of 10 to 50, with higher scores meaning more fatigue.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Met the diagnostic criteria of heart failure:cardiac function grade ⅱ-ⅲ, 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.