- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06914167
The Effectiveness of Lavender Aromatherapy Combined With Slow Breathing Exercises in Improving Occupational Burnout and Sleep Disorders Among Nursing Staff
Study Overview
Status
Conditions
Detailed Description
This study will adopt a randomized controlled trial (RCT) design targeting rotating shift nurses with at least six months of clinical experience at a regional teaching hospital in northern Taiwan. Eligible participants who consent to join the study will be randomly assigned into five groups using block randomization. The randomization process will be conducted via sealed envelopes to allocate participants into the following groups: Experimental Group 1, Experimental Group 2, Experimental Group 3, Breathing-Only Group, and Control Group.
Experimental Group 1: Participants will receive slow breathing training (6 breaths per minute) once daily before bedtime, combined with the inhalation of 3 drops of natural lavender essential oil on a towel, for 3 minutes, over a 4-week period.
Experimental Group 2: Same breathing protocol as above, with 3 drops of linalyl acetate-containing essential oil.
Experimental Group 3: Same breathing protocol, with 3 drops of linalool-containing essential oil.
Breathing-Only Group: Participants will perform slow breathing training (6 breaths per minute) for 3 minutes daily before bedtime, without any essential oil inhalation, for 4 weeks.
Control Group: Participants will maintain their usual lifestyle without any intervention.
The outcomes will be evaluated using a nurse burnout scale and a sleep quality scale. Measurements will be taken at three time points: baseline (pre-test), 4 weeks after the intervention (post-test 1), and 8 weeks after the intervention (follow-up/post-test 2).
The study is co-led by Yao-Hsiang Chen, Assistant Head Nurse at Tri-Service General Hospital Songshan Branch, and Professor Chia-Hui Lin, School of Nursing, National Defense Medical Center.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Taipei
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Taipei City, Taipei, Taiwan, 105
- Tri-Service General Hospital, Songshan Branch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Aged between 20 and 65 years Registered nurses with at least 6 months of clinical experience and currently working rotating shifts Scores ≥1 in each of the three dimensions (emotional exhaustion, reduced personal accomplishment, depersonalization) on the Nursing Burnout Scale (NBS) Willing to participate in the study and accept random assignment
Exclusion Criteria:
Nurses with less than 6 months of clinical experience Individuals with anosmia or reduced sense of smell Diagnosed with psychiatric disorders Allergic to lavender essential oil Not currently working rotating shifts
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
Participants will maintain their usual lifestyle without any intervention.
|
|
|
Placebo Comparator: Breathing-Only Group
Participants will perform slow breathing training (6 breaths per minute) for 3 minutes daily before bedtime, without any essential oil inhalation, for 4 weeks.
|
Participants will perform slow breathing (6 breaths/min) for 3 minutes daily before bedtime
|
|
Experimental: Experimental Group 1
Participants will receive slow breathing training (6 breaths per minute) once daily before bedtime, combined with the inhalation of 3 drops of natural lavender essential oil on a towel, for 3 minutes, over a 4-week period.
|
Participants will perform slow breathing (6 breaths/min) for 3 minutes daily before bedtime
inhalation of 3 drops of lavender essential oil on a towel,
|
|
Experimental: Experimental Group 2
Same breathing protocol as above, with 3 drops of linalyl acetate-containing essential oil on a towel, for 3 minutes, over a 4-week period.
|
Participants will perform slow breathing (6 breaths/min) for 3 minutes daily before bedtime
inhalation of 3 drops of linalyl acetate essential oil on a towel.
|
|
Experimental: Experimental Group 3
Same breathing protocol, with 3 drops of linalool-containing essential oil on a towel, for 3 minutes, over a 4-week period.
|
Participants will perform slow breathing (6 breaths/min) for 3 minutes daily before bedtime
inhalation of 3 drops of linalool essential oil on a towel.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nursing Burnout Scale, NBS
Time Frame: At baseline, and at 4 and 8 weeks following the start of intervention
|
The Nurse Burnout Inventory is specifically developed based on nurses' clinical practice experiences.
It includes items that reflect three key dimensions: emotional exhaustion resulting from the high-tension clinical work environment, reduced personal accomplishment associated with feelings of ineffectiveness in medical care, and depersonalization, characterized by indifference toward others due to prolonged burnout.
|
At baseline, and at 4 and 8 weeks following the start of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Chinese version of the Pittsburgh Sleep Quality Index, CPSQI
Time Frame: At baseline, and at 4 and 8 weeks following the start of intervention
|
The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-reported questionnaire designed to assess sleep quality over the past month.
It evaluates multiple aspects of sleep, including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction.
A higher score indicates poorer sleep quality.
|
At baseline, and at 4 and 8 weeks following the start of intervention
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Bavarsad NH, Bagheri S, Kourosh-Arami M, Komaki A. Aromatherapy for the brain: Lavender's healing effect on epilepsy, depression, anxiety, migraine, and Alzheimer's disease: A review article. Heliyon. 2023 Jul 20;9(8):e18492. doi: 10.1016/j.heliyon.2023.e18492. eCollection 2023 Aug.
- Sugawara Y, Shigetho A, Yoneda M, Tuchiya T, Matumura T, Hirano M. Relationship between mood change, odour and its physiological effects in humans while inhaling the fragrances of essential oils as well as linalool and its enantiomers. Molecules. 2013 Mar 13;18(3):3312-38. doi: 10.3390/molecules18033312.
- Zangaro GA, Dulko D, Sullivan D, Weatherspoon D, White KM, Hall VP, Squellati R, Donnelli A, James J, Wilson DR. Systematic Review of Burnout in US Nurses. Nurs Clin North Am. 2022 Mar;57(1):1-20. doi: 10.1016/j.cnur.2021.11.001.
- Zaccaro A, Piarulli A, Melosini L, Menicucci D, Gemignani A. Neural Correlates of Non-ordinary States of Consciousness in Pranayama Practitioners: The Role of Slow Nasal Breathing. Front Syst Neurosci. 2022 Mar 21;16:803904. doi: 10.3389/fnsys.2022.803904. eCollection 2022.
- Yang CP, Yang CC, Tsai IJ, Lin TH, Chiou YL, Wang HF, Chang CM, Yih KH. The immediate effects of lavender-based essential oil inhalation on subsequent polysomnography in people with poor sleep quality. J Chin Med Assoc. 2023 Jul 1;86(7):665-671. doi: 10.1097/JCMA.0000000000000932. Epub 2023 Apr 25.
- Sullivan V, Hughes V, Wilson DR. Nursing Burnout and Its Impact on Health. Nurs Clin North Am. 2022 Mar;57(1):153-169. doi: 10.1016/j.cnur.2021.11.011. Epub 2022 Feb 9.
- Moghadam ZE, Delmoradi F, Aemmi SZ, Vaghee S, Vashani HB. Effectiveness of aromatherapy with inhaled lavender essential oil and breathing exercises on ECT-related anxiety in depressed patients. Explore (NY). 2022 Nov-Dec;18(6):683-687. doi: 10.1016/j.explore.2021.12.006. Epub 2021 Dec 30.
- Laborde S, Allen MS, Borges U, Dosseville F, Hosang TJ, Iskra M, Mosley E, Salvotti C, Spolverato L, Zammit N, Javelle F. Effects of voluntary slow breathing on heart rate and heart rate variability: A systematic review and a meta-analysis. Neurosci Biobehav Rev. 2022 Jul;138:104711. doi: 10.1016/j.neubiorev.2022.104711. Epub 2022 May 24.
- Hedigan F, Sheridan H, Sasse A. Benefit of inhalation aromatherapy as a complementary treatment for stress and anxiety in a clinical setting - A systematic review. Complement Ther Clin Pract. 2023 Aug;52:101750. doi: 10.1016/j.ctcp.2023.101750. Epub 2023 Apr 5.
- Balban MY, Neri E, Kogon MM, Weed L, Nouriani B, Jo B, Holl G, Zeitzer JM, Spiegel D, Huberman AD. Brief structured respiration practices enhance mood and reduce physiological arousal. Cell Rep Med. 2023 Jan 17;4(1):100895. doi: 10.1016/j.xcrm.2022.100895. Epub 2023 Jan 10.
- Antczak-Komoterska A, Haor B, Malinowska M, Grzelak L, Biercewicz M, Kochman D, Krajewska K, Filipska-Blejder K, Wisniewski A, Slusarz R. Analysis of the Level of Stress and Methods of Coping with Stress among the Nursing Staff. Nurs Rep. 2023 Sep 14;13(3):1318-1330. doi: 10.3390/nursrep13030111.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TSGH-SS_E_114015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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