Clinical trial NCT02445378: Aromatherapy and Essential Oils in Improving Insomnia and Other Symptoms in Patients With Newly Diagnosed Acute Leukemia Undergoing Chemotherapy
Official title: The Effect of Aromatherapy on Insomnia and Other Common Cancer Patient Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Leukemia
Anorexia
Anxiety
Depression
Dyspnea
Insomnia
Nausea
Pain
Keywords: Aromatherapy
essential oils
Acute Leukemia
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2015-05-15
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement of Insomnia graded by Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 1 month
Secondary outcomes:
measure: 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)
timeFrame: Baseline to 2 weeks
measure: Rate of positive experience with aromatherapy
timeFrame: Up to 2 weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Lisa Blackburn, MS,RN,AOCNS
role: PRINCIPAL_INVESTIGATOR
References: