Aromatherapy and Essential Oils in Improving Insomnia and Other Symptoms in Patients With Newly Diagnosed Acute Leukemia Undergoing Chemotherapy
NCT ID: NCT02445378
Last Updated: 2019-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2014-12-28
2016-11-05
Brief Summary
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Detailed Description
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I. Does the addition of aromatherapy by diffusion of essential oils improve insomnia in newly diagnosed, hospitalized leukemia patients?
SECONDARY OBJECTIVES:
I. Does the addition of aromatherapy by diffusion of essential oils improve other common symptoms in newly diagnosed, hospitalized leukemia patients, including pain, nausea, lack of appetite, shortness of breath, depression, anxiety and wellbeing? II. Do newly diagnosed, hospitalized leukemia patients find the use of aromatherapy for symptom management a positive experience?
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients select between 3 scented essential oils: peppermint, lavender, or chamomile which is diffused in the hospital room from approximately 9 PM in the evening until morning during week 1 and placebo intervention using rose water during week 2.
GROUP II: Patients undergo placebo intervention using rose water during week 1 and aromatherapy and essential oils as in Group I during week 2.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Group I (aromatherapy and essential oils week 1)
Patients select between 3 scented essential oils: peppermint, lavender, or chamomile which is diffused in the hospital room from approximately 9 PM in the evening until morning during week 1 and placebo intervention using rose water during week 2.
Aromatherapy and Essential Oils
Undergo aromatherapy and essential oils
Placebo
Undergo placebo intervention using rose water
Questionnaire Administration
Ancillary studies
Group II (aromatherapy and essential oils week 3)
Patients undergo placebo intervention using rose water during week 1 and aromatherapy and essential oils as in Group I during week 2.
Aromatherapy and Essential Oils
Undergo aromatherapy and essential oils
Placebo
Undergo placebo intervention using rose water
Questionnaire Administration
Ancillary studies
Interventions
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Aromatherapy and Essential Oils
Undergo aromatherapy and essential oils
Placebo
Undergo placebo intervention using rose water
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Sleep apnea
* Planned less than two week hospitalization
* Change in pain medications/sleeping medications/anxiety medications/antiemetics during the trial
* Patients who have not completed their initial steroids
* Patients who are confused and unable to give informed consent
ALL
No
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Lisa Blackburn
Principal Investigator
Principal Investigators
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Lisa Blackburn, MS,RN,AOCNS
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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Related Links
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The Jamesline
Other Identifiers
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NCI-2015-00549
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-14182
Identifier Type: -
Identifier Source: org_study_id
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