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

NCT03867864 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2019-03-26

No results posted yet for this study

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.

Conditions

  • Headache, Migraine
  • Quality of Life

Interventions

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.

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Hao-Yuan Chang, Asst. Prof. · School of Nursing, College of Medicine, National Taiwan University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-15
Primary Completion
2019-12-31
Completion
2019-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03867864 on ClinicalTrials.gov