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NCT03867864
Effects of Aromatherapy on the Headache and Service Quality Among Nurses Working in Critical Care Nurses Units.
NA trial testing Necklace with essential oil for the first 4 weeks in Headache, Migraine in 103 participants. Status unknown.
31 December 2019
Quick facts
| Lead sponsor | National Taiwan University Hospital |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | other |
| Enrollment | 103 |
| Start date | 15 March 2019 |
| Primary completion | 31 December 2019 |
| Estimated completion | 31 December 2019 |
Drugs / interventions tested
- Necklace with essential oil for the first 4 weeks
- Necklace without essential oil for the first 4 weeks
- Washout
- Necklace with essential oil for last 4 weeks
- Necklace without essential oil for last 4 weeks
Conditions studied
- Headache, Migraine — all drugs for Headache, Migraine →
- Quality of Life — all drugs for Quality of Life →
Sponsor
National Taiwan University Hospital
Who can join
Adults 20 to 65, any sex, with Headache, Migraine or Quality of Life. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03867864 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Taiwan University Hospital
- Last refreshed: 26 March 2019
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