Acute Leukemia, Anorexia, Anxiety, Depression, Dyspnea, Insomnia, Nausea, Pain
Conditions
Keywords
Aromatherapy, essential oils, Acute Leukemia
Brief summary
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
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.
Interventions
PROCEDUREAromatherapy and Essential Oils
Undergo aromatherapy and essential oils
OTHERPlacebo
Undergo placebo intervention using rose water
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of Insomnia graded by Pittsburgh Sleep Quality Index (PSQI) | 1 month | 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. |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed