Headache, MigraineNCT03867864
Effects of Aromatherapy on the Headache and Service Quality Among Nurses Working in Critical Care Nurses Units.
A study testing Necklace with essential oil for the first 4 weeks, Necklace without essential oil for the first 4 weeks and Washout in people with Headache, Migraine and Quality of Life, run by National Taiwan University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache, Migraine, Quality of Life
- What is being tested?
- Necklace with essential oil for the first 4 weeks, Necklace without essential oil for the first 4 weeks and Washout
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Hao-Yuan Chang, Assistant Professor, School of Nursing, National Taiwan University
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.
Read more
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.
Read the 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
- Being 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
- Keywords
- Headache, Migraine, Disability, Quality of life, Nurse, Aromatherapy, Essential oils, Missed care
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Necklace with essential oil for the first 4 weeksDevice
The necklaces contain essential oil.
Necklace without essential oil for the first 4 weeksDevice
The necklaces do not contain essential oil.
WashoutOther
Washout (do not wear the necklace) for one week for two groups, then two groups cross-over.
Necklace with essential oil for last 4 weeksDevice
The necklaces contain essential oil.
Necklace without essential oil for last 4 weeksDevice
The necklaces do not contain essential oil.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 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). Receives: Device: Necklace with essential oil for the first 4 weeks; Other: Washout; Device: Necklace without essential oil for last 4 weeks |
| Group B | Other | 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). Receives: Device: Necklace without essential oil for the first 4 weeks; Other: Washout; Device: Necklace with essential oil for last 4 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Headache Diary
The Headache Diary measured the participants to record the condition of headache with 12 items. The investigators will analyzed the intensity, frequency, duration, location, quality, symptoms, time and medicine use, and the duration (hours) of wearing the necklace with essential oil. At the meanwhile, we also collect the perceived busy level of the work day to control the association between the workload and headache. Thus, the participants have to write the diary everyday for 9 weeks and we will remind them by the text. The diary also mixes in the short-form McGill pain questionnaire (SF-MPQ) that was developed by Melzack in 1975 and revised in 1987 and it developed from the different type of headache depending on the pain intensity and quality (Melzack, 1975). The investigators simplified the contents and transfer to code so that the participants can easily fill out the diary every day.
Measured: 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)
Changes of Headache Disability Inventory (HDI)
The Headache Disability Inventory (HDI) measured the burden caused by chronic headaches with 27 items (French et al., 2000). Each item scored from 1 to 3 (1= always happened; 3 = never happened). The higher score indicated the higher impacts of headache on emotional function and daily life.
Measured: The participants will be assessed among pre-test week 1 (T1), week 5 (T2) and week 10 (T3)
Changes of Migraine Specific Quality of Life Questionnaire version 2.1 (MSQv2.1)
The Migraine Specific Quality of Life Questionnaire version 2.1 (MSQv2.1) measured the quality of life of migraine and headache patients, including the function, limitation, burden and impacts of the migraine with 14 items (Bagley et al., 2011). Each item was scored from 1 to 6 (1= always happened; 6 = never happened). The higher score indicated the higher impact of headache on quality of life. Cronbach's alphas are 0.79-0.85 (Bagley et al., 2011).
Measured: The participants will be assessed among pre-test week 1 (T1), week 5 (T2) and week 10 (T3)
Changes of Copenhagen Burnout Inventory (CBI)
The Copenhagen Burnout Inventory (CBI) measured occupational burnout with 21 items (Yah et al, 2008). The questionnaire is including subscales-personal burnout, work-related burnout, client-related burnout, and over-commitment to work. Each item scored from 1 to 5 (1= never happened, 5 = always happened). The higher scores indicated the stronger work burnout. Cronbach's alphas are 0.89-0.95 (Yang et al, 2014).
Measured: The participants will be assessed among pre-test week 1 (T1), week 5 (T2) and week 10 (T3)
Changes of Service Quality Scale (SERVQUAL)
The Service Quality Scale (SERVQUAL) measured the care quality of nurses in the hospital, including the four domains: trustworthiness, responsiveness, promise and empathy with 28 Likert's scale items (Teng et al., 2007). Each item scored from 1 to 5 (1= strongly disagree; 5 = strongly agree). The higher score indicated the higher confidence on their care quality.
Measured: The participants will be assessed among pre-test week 1 (T1), week 5 (T2) and week 10 (T3)
Changes of Intention to Leave Inventory (ITL)
The Intention to Leave Inventory (ITL) measured the intention to leave the organization and their future career plan with 7 Likert's scale items (Teng, Shyu, \& Chang, 2007). Each item scored from 1 to 7 (1= strongly disagree; 7 = strongly agree). The higher score indicated the higher strongly intention to leave the organization.
Measured: The participants will be assessed among pre-test week 1 (T1), week 5 (T2) and week 10 (T3)
Changes of Depression, Anxiety and Stress Scale (DASS-21)
The Depression, Anxiety and Stress Scale (DASS-21) measured the level of depression, anxiety and stress during the past week recently by 21 items (Moussa, 2001). Each item scored from 1 to 4 (1= strongly disagree; 4 = strongly agree). The higher score indicated more frequency of feeling depression, anxiety and stress (Lovibond \& Lovibond, 2004). Cronbach's alphas were 0.87-0.94 (Black et al., 2015).
Measured: The participants will be assessed among pre-test week 1 (T1), week 5 (T2) and week 10 (T3)
Demographic and Headache Information Questionnaire
The Demographic Questionnaire included the birth date, sex, marital status, amenorrhea, education, unit, working years and rank. Although the necklace's colors are distributed randomly, considering the color may also affect the participants 'mood or the condition of headache, therefore, The investigators also survey the subject's preference of color to control the potential effect. The Headache Information Questionnaire was modified from the International Classification of Headache Disorders (ICHD, 3rd edition) to identify the headache type as "migraine" or "tension-type headache. Items included pain intensity, frequency, onset of the times, symptoms, locations, etc.
Measured: The participants will be assessed at pre-test week 1 (T1)
Tasks Undone-13
The tasks undone-13 measured the missed care with 13 items (Aiken et al; Ball et al., 2013; Schubert, 2007). Each item scored from 0 to 1 (0 = left done, 1 = done and NA= not applicable) The higher score indicated the volume of care left done. Cronbach's alpha = 0.73 (Lucero et al., 2009) and content validity index is 0.70-0.91 (Squires et al., 2013)。
Measured: The participants will be assessed among pre-test week 1 (T1), week 5 (T2) and week 10 (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start15 Mar 2019 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Headache, MigraineStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hao-Yuan Chang, Asst. Prof., Study chair, School of Nursing, College of Medicine, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867864
- Sponsor's protocol ID
- 201710020RINA
- Status last verified
- Feb 2019
- First submitted
- 6 Mar 2019
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21929662French 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.
PubMed 10971661Lovibond, 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.
PubMed 1235985Moussa, 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.
PubMed 17292133Aiken 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.
PubMed 11585181Ball 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.
PubMed 23898215Lucero 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.
PubMed 19737326Schubert 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.
PubMed 18004188Squires 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.
PubMed 22445444
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hao-Yuan Chang, Assistant Professor, School of Nursing, National Taiwan University
- ClinicalTrials.gov ID
- NCT03867864
- Acronym / sponsor ID
- 201710020RINA
- Conditions
- Headache, Migraine, Quality of Life
- Keywords
- Headache, Migraine, Disability, Quality of life, Nurse, Aromatherapy, Essential oils, Missed care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 Mar 2019 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 8 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Necklace with essential oil for the first 4 weeks, Other: Washout, Device: Necklace without essential oil for last 4 weeksGroup 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). |
| Group B | Other | Device: Necklace without essential oil for the first 4 weeks, Other: Washout, Device: Necklace with essential oil for last 4 weeksThe 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). |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Necklace with essential oil for the first 4 weeksThe necklaces contain essential oil. | Device | Group A |
| Necklace without essential oil for the first 4 weeksThe necklaces do not contain essential oil. | Device | Group B |
| WashoutWashout (do not wear the necklace) for one week for two groups, then two groups cross-over. | Other | Group A, Group B |
| Necklace with essential oil for last 4 weeksThe necklaces contain essential oil. | Device | Group B |
| Necklace without essential oil for last 4 weeksThe necklaces do not contain essential oil. | Device | Group A |
Primary outcome
Changes of Headache Diary
Time frame: 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)
The Headache Diary measured the participants to record the condition of headache with 12 items. The investigators will analyzed the intensity, frequency, duration, location, quality, symptoms, time and medicine use, and the duration (hours) of wearing the necklace with essential oil. At the meanwhile, we also collect the perceived busy level of the work day to control the association between the workload and headache. Thus, the participants have to write the diary everyday for 9 weeks and we will remind them by the text. The diary also mixes in the short-form McGill pain questionnaire (SF-MPQ) that was developed by Melzack in 1975 and revised in 1987 and it developed from the different type of headache depending on the pain intensity and quality (Melzack, 1975). The investigators simplified the contents and transfer to code so that the participants can easily fill out the diary every day.
Changes of Headache Disability Inventory (HDI)
Time frame: The participants will be assessed among pre-test week 1 (T1), week 5 (T2) and week 10 (T3)
The Headache Disability Inventory (HDI) measured the burden caused by chronic headaches with 27 items (French et al., 2000). Each item scored from 1 to 3 (1= always happened; 3 = never happened). The higher score indicated the higher impacts of headache on emotional function and daily life.
Changes of Migraine Specific Quality of Life Questionnaire version 2.1 (MSQv2.1)
Time frame: The participants will be assessed among pre-test week 1 (T1), week 5 (T2) and week 10 (T3)
The Migraine Specific Quality of Life Questionnaire version 2.1 (MSQv2.1) measured the quality of life of migraine and headache patients, including the function, limitation, burden and impacts of the migraine with 14 items (Bagley et al., 2011). Each item was scored from 1 to 6 (1= always happened; 6 = never happened). The higher score indicated the higher impact of headache on quality of life. Cronbach's alphas are 0.79-0.85 (Bagley et al., 2011).
Changes of Copenhagen Burnout Inventory (CBI)
Time frame: The participants will be assessed among pre-test week 1 (T1), week 5 (T2) and week 10 (T3)
The Copenhagen Burnout Inventory (CBI) measured occupational burnout with 21 items (Yah et al, 2008). The questionnaire is including subscales-personal burnout, work-related burnout, client-related burnout, and over-commitment to work. Each item scored from 1 to 5 (1= never happened, 5 = always happened). The higher scores indicated the stronger work burnout. Cronbach's alphas are 0.89-0.95 (Yang et al, 2014).
Changes of Service Quality Scale (SERVQUAL)
Time frame: The participants will be assessed among pre-test week 1 (T1), week 5 (T2) and week 10 (T3)
The Service Quality Scale (SERVQUAL) measured the care quality of nurses in the hospital, including the four domains: trustworthiness, responsiveness, promise and empathy with 28 Likert's scale items (Teng et al., 2007). Each item scored from 1 to 5 (1= strongly disagree; 5 = strongly agree). The higher score indicated the higher confidence on their care quality.
Changes of Intention to Leave Inventory (ITL)
Time frame: The participants will be assessed among pre-test week 1 (T1), week 5 (T2) and week 10 (T3)
The Intention to Leave Inventory (ITL) measured the intention to leave the organization and their future career plan with 7 Likert's scale items (Teng, Shyu, \& Chang, 2007). Each item scored from 1 to 7 (1= strongly disagree; 7 = strongly agree). The higher score indicated the higher strongly intention to leave the organization.
Changes of Depression, Anxiety and Stress Scale (DASS-21)
Time frame: The participants will be assessed among pre-test week 1 (T1), week 5 (T2) and week 10 (T3)
The Depression, Anxiety and Stress Scale (DASS-21) measured the level of depression, anxiety and stress during the past week recently by 21 items (Moussa, 2001). Each item scored from 1 to 4 (1= strongly disagree; 4 = strongly agree). The higher score indicated more frequency of feeling depression, anxiety and stress (Lovibond \& Lovibond, 2004). Cronbach's alphas were 0.87-0.94 (Black et al., 2015).
Demographic and Headache Information Questionnaire
Time frame: The participants will be assessed at pre-test week 1 (T1)
The Demographic Questionnaire included the birth date, sex, marital status, amenorrhea, education, unit, working years and rank. Although the necklace's colors are distributed randomly, considering the color may also affect the participants 'mood or the condition of headache, therefore, The investigators also survey the subject's preference of color to control the potential effect. The Headache Information Questionnaire was modified from the International Classification of Headache Disorders (ICHD, 3rd edition) to identify the headache type as "migraine" or "tension-type headache. Items included pain intensity, frequency, onset of the times, symptoms, locations, etc.
Tasks Undone-13
Time frame: The participants will be assessed among pre-test week 1 (T1), week 5 (T2) and week 10 (T3)
The tasks undone-13 measured the missed care with 13 items (Aiken et al; Ball et al., 2013; Schubert, 2007). Each item scored from 0 to 1 (0 = left done, 1 = done and NA= not applicable) The higher score indicated the volume of care left done. Cronbach's alpha = 0.73 (Lucero et al., 2009) and content validity index is 0.70-0.91 (Squires et al., 2013)。
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- BackgroundYeh, 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.
- BackgroundYang, 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.
- Background: PubMed 21929662Bagley 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.
- Background: PubMed 10971661French 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.
- BackgroundLovibond, S. H., & Lovibond, P. F.(2004). Manual for the depression anxiety stress scale. (2nd Ed.). Sydney, Australia: Psychology Foundation Monograph.
- BackgroundMason, M. (1996). Aromatherapy and midwifery. Aromatherapy. Quarterly spring issue, 32-34.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hao-Yuan Chang, Asst. Prof. study chair
School of Nursing, College of Medicine, National Taiwan University
Questions about this trial
What is this clinical trial studying?
A study testing Necklace with essential oil for the first 4 weeks, Necklace without essential oil for the first 4 weeks and Washout in people with Headache, Migraine and Quality of Life, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao-Yuan Chang, Asst. Prof. (+886-2-23123456 ext. 88893, hauiuan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Headache Diary (time frame: 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)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03867864, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.