Effects of Lavender Essential Oil in Patients With Chronic Heart Failure

NCT05862350 | Unknown

• 1 other identifier: XJTU1AF2022LSK-400
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

1. 1.effects of lavender essential oil on sleep quality
2. 2.effects of lavender essential oil on anxiety
3. 3.effects of lavender essential oil on fatigue

Conditions

Chronic Heart Failure

Keywords

Chronic Heart Failure; lavender essential oil; sleep quality; Anxiety Disorders; Fatigue

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Aromatherapy inhalation with lavender essential oil

EXPERIMENTAL

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

Aromatherapy inhalation with coconut essential oil

PLACEBO COMPARATOR

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.

Interventions

aromatherapy inhalation with lavender essential oil OTHER

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 lavender essential oil

aromatherapy inhalation with coconut essential oil. OTHER

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

Aromatherapy inhalation with coconut essential oil

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Related Publications (11)

• 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.

  PMID: 8712779 BACKGROUND

• 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.

  PMID: 25930162 BACKGROUND

• 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.

  PMID: 25715645 BACKGROUND

• 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.

  PMID: 28595441 BACKGROUND

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

  PMID: 12112282 BACKGROUND

• 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.

  PMID: 31003666 BACKGROUND

• 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.

  PMID: 33905827 BACKGROUND

• 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.

  PMID: 34954406 BACKGROUND

• 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.

  PMID: 33548936 BACKGROUND

• 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.

  PMID: 32572778 BACKGROUND

• Hu J, Chong MS, Jia Y, Wu Y, Li J, Wang W. Effects of lavender essential oil inhalation on sleep quality and fatigue in patients with chronic heart failure: a randomised controlled trial. Eur J Cardiovasc Nurs. 2026 Jan 7:zvag006. doi: 10.1093/eurjcn/zvag006. Online ahead of print.

  PMID: 41499426 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Anxiety Disorders; Fatigue

Interventions

lavender oil

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jingwen Hu, Master

  the First Afiliated Hospital of Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingwen Hu, Master

CONTACT

008602985383801; jingwenhu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: May 17, 2023
• Study Start: May 10, 2023
• Primary Completion: July 30, 2023
• Study Completion: October 30, 2023
• Last Updated: May 17, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share