Effects of Aromatherapy on the Headache and Service Quality Among Nurses Working in Critical Care Nurses Units.
NCT ID: NCT03867864
Last Updated: 2019-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
103 participants
INTERVENTIONAL
2019-03-15
2019-12-31
Brief Summary
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Purpose: Thus, in this intervention study, we will examine whether the necklace with essential oil can (1) improve the pain intensity and frequency of headache; (2) reduce the score of headache disability inventory (HDI) and (3) improve the nurses' quality of life and care quality.
Method: Cluster randomized control trial from 16 critical care units at a medical center in Taiwan. The International Classification of Headache Disorders (ICHD, 3rd edition) was used to identify the headache type as "migraine" or "tension-type headache." We will recruit the nurses from 16 critical care units who has migraine or tension-type headache and cluster random assign (according to the ward unit) to group A and B. The intervention of necklace with essential oil will use to compare with the other group. According to power analysis and possible attrition rate, 103 nurses will be recruited. All participants will be asked to complete self-administrated questionnaires, including headache information questions, headache disability inventory (HDI), Migraine Specific Quality of Life Questionnaire version 2.1 (MSQv2.1), Copenhagen burnout inventory (CBI), Service Quality Scale (SERVQUAL), Intention to leave inventory (ITL), Depression, Anxiety and Stress Scale (DASS-21), Tasks Undone-13 (TU-13). The quantitative data will analyze by percentage, mean, standard deviation, chi-square test, and generalized estimating equation (GEE).
Expected outcomes and future implications: The aromatherapy (necklace with essential oil) can reduce the pain intensity, frequency, disability of headaches, as well as enhance nurses' quality of life and care quality.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
SINGLE
Study Groups
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Group A
Group A participants will wear the necklace with essential oil for the first 4 weeks except take a shower or get to sleep. The participants will stop wearing the necklace for one week (the fifth week) for washout period, and then wear the necklace without essential oil for last 4 weeks (the sixth to ninth weeks).
Necklace with essential oil for the first 4 weeks
The necklaces contain essential oil.
Washout
Washout (do not wear the necklace) for one week for two groups, then two groups cross-over.
Necklace without essential oil for last 4 weeks
The necklaces do not contain essential oil.
Group B
The group B will wear the necklace without essential oil for the first 4 weeks except take a shower or get to sleep. The participants will stop wearing the necklace for one week (the fifth week) for washout period, and then wear the necklace with essential oil for last 4 weeks (the sixth to ninth weeks).
Necklace without essential oil for the first 4 weeks
The necklaces do not contain essential oil.
Washout
Washout (do not wear the necklace) for one week for two groups, then two groups cross-over.
Necklace with essential oil for last 4 weeks
The necklaces contain essential oil.
Interventions
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Necklace with essential oil for the first 4 weeks
The necklaces contain essential oil.
Necklace without essential oil for the first 4 weeks
The necklaces do not contain essential oil.
Washout
Washout (do not wear the necklace) for one week for two groups, then two groups cross-over.
Necklace with essential oil for last 4 weeks
The necklaces contain essential oil.
Necklace without essential oil for last 4 weeks
The necklaces do not contain essential oil.
Eligibility Criteria
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Inclusion Criteria
* The frequency of headaches more than three times per month.
* The type of headache is migraine or frequent episodic tension-type headache, which is defined by the Headache Classification Committee of the International Headache Society. If the symptoms of a headache cannot be defined, the investigator will refer the potential participant to a neurologist for further diagnosis.
Exclusion Criteria
* Having sensitive responses to the essential oil.
* Pregnancy or preparing for pregnancy.
* Breastfeeding.
* The type of headache was neither migraine nor frequent episodic tension-type headache after diagnosed by the neurologist.
* With hepatic or renal diseases.
* taking medicine for long-term (such as Aspirin, anti-coagulant, medication for mental disorders, contraceptives, etc.).
20 Years
65 Years
ALL
Yes
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Hao-Yuan Chang, Asst. Prof.
Role: STUDY_CHAIR
School of Nursing, College of Medicine, National Taiwan University
Central Contacts
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References
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Yeh, W. Y., Cheng, Y. W., Chen, M. J., Chiu, H. W. (2008). Development and validation of an occupational burnout inventory. Taiwan Journal of Public Health, 27(5)，349-464.
Yang, W. C., Hu, C. H., Wu, I, T. (2014). This study the relationship of working hours, stress studies and workplace fatigue in nursing staff. Journal of Sport and Recreation Management, 11 (1), 114-131.
Bagley CL, Rendas-Baum R, Maglinte GA, Yang M, Varon SF, Lee J, Kosinski M. Validating Migraine-Specific Quality of Life Questionnaire v2.1 in episodic and chronic migraine. Headache. 2012 Mar;52(3):409-21. doi: 10.1111/j.1526-4610.2011.01997.x. Epub 2011 Sep 19.
French DJ, Holroyd KA, Pinell C, Malinoski PT, O'Donnell F, Hill KR. Perceived self-efficacy and headache-related disability. Headache. 2000 Sep;40(8):647-56. doi: 10.1046/j.1526-4610.2000.040008647.x.
Lovibond, S. H., & Lovibond, P. F.(2004). Manual for the depression anxiety stress scale. (2nd Ed.). Sydney, Australia: Psychology Foundation Monograph.
Mason, M. (1996). Aromatherapy and midwifery. Aromatherapy. Quarterly spring issue, 32-34.
Melzack R. The McGill Pain Questionnaire: major properties and scoring methods. Pain. 1975 Sep;1(3):277-299. doi: 10.1016/0304-3959(75)90044-5.
Moussa, M.T., Lovibond, P.F. & Laube, R. (2001). Psychometric properties of a Chinese version of the short Depression Anxiety Stress Scales (DASS21). Report for New South Wales Transcultural Mental Health Centre, Cumberland Hospital, Sydney.
Teng CI, Lotus Shyu YI, Chang HY. Moderating effects of professional commitment on hospital nurses in Taiwan. J Prof Nurs. 2007 Jan-Feb;23(1):47-54. doi: 10.1016/j.profnurs.2006.10.002.
Aiken LH, Clarke SP, Sloane DM, Sochalski JA, Busse R, Clarke H, Giovannetti P, Hunt J, Rafferty AM, Shamian J. Nurses' reports on hospital care in five countries. Health Aff (Millwood). 2001 May-Jun;20(3):43-53. doi: 10.1377/hlthaff.20.3.43.
Ball JE, Murrells T, Rafferty AM, Morrow E, Griffiths P. 'Care left undone' during nursing shifts: associations with workload and perceived quality of care. BMJ Qual Saf. 2014 Feb;23(2):116-25. doi: 10.1136/bmjqs-2012-001767. Epub 2013 Jul 29.
Lucero RJ, Lake ET, Aiken LH. Variations in nursing care quality across hospitals. J Adv Nurs. 2009 Nov;65(11):2299-310. doi: 10.1111/j.1365-2648.2009.05090.x. Epub 2009 Sep 8.
Schubert M, Glass TR, Clarke SP, Schaffert-Witvliet B, De Geest S. Validation of the Basel Extent of Rationing of Nursing Care instrument. Nurs Res. 2007 Nov-Dec;56(6):416-24. doi: 10.1097/01.NNR.0000299853.52429.62.
Squires A, Aiken LH, van den Heede K, Sermeus W, Bruyneel L, Lindqvist R, Schoonhoven L, Stromseng I, Busse R, Brzostek T, Ensio A, Moreno-Casbas M, Rafferty AM, Schubert M, Zikos D, Matthews A. A systematic survey instrument translation process for multi-country, comparative health workforce studies. Int J Nurs Stud. 2013 Feb;50(2):264-73. doi: 10.1016/j.ijnurstu.2012.02.015. Epub 2012 Mar 23.
Other Identifiers
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201710020RINA
Identifier Type: -
Identifier Source: org_study_id
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