NCT03867864

Effects of Aromatherapy on the Headache and Service Quality Among Nurses Working in Critical Care Nurses Units.

Hao-Yuan Chang, Assistant Professor, School of Nursing, National Taiwan University

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Headache, Migraine
• Quality of Life

Interventions

Type	Name	Description
DEVICE	Necklace with essential oil for the first 4 weeks	The necklaces contain essential oil.
DEVICE	Necklace without essential oil for the first 4 weeks	The necklaces do not contain essential oil.
OTHER	Washout	Washout (do not wear the necklace) for one week for two groups, then two groups cross-over.
DEVICE	Necklace with essential oil for last 4 weeks	The necklaces contain essential oil.
DEVICE	Necklace without essential oil for last 4 weeks	The necklaces do not contain essential oil.

Timeline

• Start date: 2019-03-15
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2019-03-08
• Last updated: 2019-03-26