Effects of Lavender Essential Oil in Patients With Chronic Heart Failure

May 8, 2023 updated by: First Affiliated Hospital Xi'an Jiaotong University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Pittsburgh Sleep Quality Index
Time Frame: 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.
at base line,7th day, 14th day, 28th day
Change of State-trait anxiety inventory
Time Frame: 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.
at base line,7th day, 14th day, 28th day
Change of the Fatigue Assessment Scale
Time Frame: 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.
at base line,7th day, 14th day, 28th day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Principal Investigator: Jingwen Hu, Master, the First Afiliated Hospital of Xi'an Jiaotong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 10, 2023

Primary Completion (Anticipated)

July 30, 2023

Study Completion (Anticipated)

October 30, 2023

Study Registration Dates

First Submitted

October 24, 2022

First Submitted That Met QC Criteria

May 8, 2023

First Posted (Actual)

May 17, 2023

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF2022LSK-400

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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