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Effects of Lavender Essential Oil in Patients With Chronic Heart Failure

Primary Purpose

Chronic Heart Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
aromatherapy inhalation with lavender essential oil
aromatherapy inhalation with coconut essential oil.
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring Chronic Heart Failure, lavender essential oil, sleep quality, Anxiety Disorders, Fatigue

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Aromatherapy inhalation with lavender essential oil

    Aromatherapy inhalation with coconut essential oil

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 24, 2022
    Last Updated
    May 8, 2023
    Sponsor
    First Affiliated Hospital Xi'an Jiaotong University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05862350
    Brief Title
    Effects of Lavender Essential Oil in Patients With Chronic Heart Failure
    Official Title
    Effects of Lavender Essential Oil on Sleep Quality, Anxiety, and Fatigue in Patients With Chronic Heart Failure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 10, 2023 (Anticipated)
    Primary Completion Date
    July 30, 2023 (Anticipated)
    Study Completion Date
    October 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    First Affiliated Hospital Xi'an Jiaotong University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Heart Failure
    Keywords
    Chronic Heart Failure, lavender essential oil, sleep quality, Anxiety Disorders, Fatigue

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Aromatherapy inhalation with lavender essential oil
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Aromatherapy inhalation with coconut essential oil
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    aromatherapy inhalation with lavender essential oil
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    aromatherapy inhalation with coconut essential oil.
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Change of Pittsburgh Sleep Quality Index
    Description
    The Pittsburgh Sleep Quality Index assesses sleep quality, with scores ranging from 0 to 21. Higher scores mean poorer sleep quality.
    Time Frame
    at base line,7th day, 14th day, 28th day
    Title
    Change of State-trait anxiety inventory
    Description
    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.
    Time Frame
    at base line,7th day, 14th day, 28th day
    Title
    Change of the Fatigue Assessment Scale
    Description
    The Fatigue Assessment Scale assesses fatigue levels on a scale of 10 to 50, with higher scores meaning more fatigue.
    Time Frame
    at base line,7th day, 14th day, 28th day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jingwen Hu, Master
    Phone
    008602985383801
    Email
    jingwenhu@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jingwen Hu, Master
    Organizational Affiliation
    the First Afiliated Hospital of Xi'an Jiaotong University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    8712779
    Citation
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    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.
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    PubMed Identifier
    25715645
    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.
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    Citation
    Cavanagh HM, Wilkinson JM. Biological activities of lavender essential oil. Phytother Res. 2002 Jun;16(4):301-8. doi: 10.1002/ptr.1103.
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    PubMed Identifier
    31003666
    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.
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    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.
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    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.
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    Effects of Lavender Essential Oil in Patients With Chronic Heart Failure

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