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

The Ohio State University

Status: Completed

Conditions: Nausea; Acute Leukemia; Dyspnea; Anorexia; Insomnia; Depression; Anxiety; Pain

Treatments: Other: Questionnaire Administration; Other: Placebo; Procedure: Aromatherapy and Essential Oils

Study type: Interventional

Funder types: Other

Identifiers

NCT02445378

NCI-2015-00549 (Registry Identifier)

OSU-14182

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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48 participants in 2 patient groups

Group I (aromatherapy and essential oils week 1)

Experimental group

Description:

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.

Treatment:

Procedure: Aromatherapy and Essential Oils

Other: Questionnaire Administration

Other: Placebo

Group II (aromatherapy and essential oils week 3)

Experimental group

Description:

Patients undergo placebo intervention using rose water during week 1 and aromatherapy and essential oils as in Group I during week 2.

Treatment:

Procedure: Aromatherapy and Essential Oils

Other: Questionnaire Administration

Other: Placebo