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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00549 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This randomized clinical trial studies aromatherapy and essential oils in improving insomnia and other symptoms in patients with newly diagnosed acute leukemia. Aromatherapy and essential oils may help improve insomnia and other complications caused by chemotherapy.
PRIMARY OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (aromatherapy and essential oils week 1) | Experimental | 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. |
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| Group II (aromatherapy and essential oils week 3) | Experimental | Patients undergo placebo intervention using rose water during week 1 and aromatherapy and essential oils as in Group I during week 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aromatherapy and Essential Oils | Procedure | Undergo aromatherapy and essential oils |
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| Measure | Description | Time Frame |
|---|---|---|
| Improvement of Insomnia graded by Pittsburgh Sleep Quality Index (PSQI) | Statistical analysis will be performed using a mixed effects linear regression model. This model is designed to test the effects of interest (i.e., the effect of aromatherapy relative to baseline and to placebo) while accounting for the within-subject correlation arising from the repeated measures design. A 20% positive change in PSQI score will be seen as significant. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of common symptoms including pain, nausea, lack of appetite, shortness of breath, depression, anxiety, and wellbeing graded by Edmonton Symptom Assessment Scale - revised (ESASr) | Baseline to 2 weeks | |
| Rate of positive experience with aromatherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Blackburn, MS,RN,AOCNS | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| Placebo | Other | Undergo placebo intervention using rose water |
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| Questionnaire Administration | Other | Ancillary studies |
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| Up to 2 weeks |
| ID | Term |
|---|---|
| D000855 | Anorexia |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D004417 | Dyspnea |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D009325 | Nausea |
| D010146 | Pain |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D019341 | Aromatherapy |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D008517 | Phytotherapy |
| D026421 | Sensory Art Therapies |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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