Clinical trial NCT03867864: Effects of Aromatherapy on the Headache and Service Quality Among Nurses Working in Critical Care Nurses Units.
Official title: Hao-Yuan Chang, Assistant Professor, School of Nursing, National Taiwan University
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Headache, Migraine
Quality of Life
Keywords: Headache
Migraine
Disability
Quality of life
Nurse
Aromatherapy
Essential oils
Missed care
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-03-08
Enrollment: 103
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Background: Our pilot study showed that the prevalence of headaches is 43.5% among nurses working in critical care units in a medical center in Taiwan. In the pilot study, 70% nurses with headache are willing to participate in this intervention study with essential oil. The effect of aromatherapy (essential oils through smelling) is convenient for nurses but still lacks strong evidences regarding relieving headaches.

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.

Detailed description: This study adopts an experimental design with cluster randomization based on the ward unit. Eligible subjects are diagnosed migraine or tension-type headache nurses who are working in the critical care units and also have nurse license. Before conducting this study, the study has been approved by the institutional review board (IRB). The researcher (co-PI) and research assistances will approach potential participants during the ward meeting and invite them to participate in the study. Potential participants would be informed of the study purposes and interventions process, and be assessed and confirmed their type of headache. After completing the written-informed consent, the interventions will be arranged. In order to control the quality of data collection, PI and co-PI have trained the research assistants. Research training included standardized research process and ethical concerns about collection of research data, methods of approaching eligible subjects, interviewing techniques of data collection.

Eligibility criteria: Inclusion Criteria:

* Registered nurses, working in intensive care units (ICU) or department of emergency (ED).
* 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:

* Current user of other kinds of essential oils (e.g., the external application on skin, sniffing), and do not willing to temporarily suspend for nine weeks.
* 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.).

Primary outcomes:
measure: Changes of Headache Diary
timeFrame: The participants will be assessed among pre-test week 1 (T1) and persistent to fill out the headache diary every day for 9 weeks (totally 63 days)
measure: Changes of Headache Disability Inventory (HDI)
timeFrame: The participants will be assessed among pre-test week 1 (T1), week 5 (T2) and week 10 (T3)
measure: Changes of Migraine Specific Quality of Life Questionnaire version 2.1 (MSQv2.1)
timeFrame: The participants will be assessed among pre-test week 1 (T1), week 5 (T2) and week 10 (T3)
measure: Changes of Copenhagen Burnout Inventory (CBI)
timeFrame: The participants will be assessed among pre-test week 1 (T1), week 5 (T2) and week 10 (T3)
measure: Changes of Service Quality Scale (SERVQUAL)
timeFrame: The participants will be assessed among pre-test week 1 (T1), week 5 (T2) and week 10 (T3)
measure: Changes of Intention to Leave Inventory (ITL)
timeFrame: The participants will be assessed among pre-test week 1 (T1), week 5 (T2) and week 10 (T3)
measure: Changes of Depression, Anxiety and Stress Scale (DASS-21)
timeFrame: The participants will be assessed among pre-test week 1 (T1), week 5 (T2) and week 10 (T3)
measure: Demographic and Headache Information Questionnaire
timeFrame: The participants will be assessed at pre-test week 1 (T1)
measure: Tasks Undone-13
timeFrame: The participants will be assessed among pre-test week 1 (T1), week 5 (T2) and week 10 (T3)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: School of Nursing, College of Medicine, National Taiwan University
name: Hao-Yuan Chang, Asst. Prof.
role: STUDY_CHAIR
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