Aromatherapy and Essential Oils in Improving Insomnia and Other Symptoms in Patients With Newly Diagnosed Acute Leukemia Undergoing Chemotherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Aromatherapy on Insomnia and Other Common Cancer Patient Symptoms

Conditions
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Acute Leukemia, Anorexia, Anxiety, Depression, Dyspnea, Insomnia, Nausea, Pain

Intervention / Treatment
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* Procedure: Aromatherapy and Essential Oils
* Other: Placebo
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are newly diagnosed with acute leukemia and hospitalized to receive their initial 4 weeks of intensive induction chemotherapy for this disease Exclusion Criteria: Asthma or other reactive airway disease 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (aromatherapy and essential oils week 1)<br>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. | Procedure: Aromatherapy and Essential Oils<br>* Undergo aromatherapy and essential oils<br>* Other names: Aromatherapy;Other: Placebo<br>* Undergo placebo intervention using rose water<br>* Other names: sham therapy;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Group II (aromatherapy and essential oils week 3)<br>Patients undergo placebo intervention using rose water during week 1 and aromatherapy and essential oils as in Group I during week 2. | Procedure: Aromatherapy and Essential Oils<br>* Undergo aromatherapy and essential oils<br>* Other names: Aromatherapy;Other: Placebo<br>* Undergo placebo intervention using rose water<br>* Other names: sham therapy;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | Up to 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aromatherapy, essential oils, Acute Leukemia