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

Not Applicable

Completed

• Conditions: Anxiety; Nausea; Dyspnea; Pain; Acute Leukemia; Anorexia; Depression; Insomnia
• Interventions: Procedure: Aromatherapy and Essential Oils; Other: Placebo; Other: Questionnaire Administration

• Registration Number: NCT02445378
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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.

Study Timeline

• Study Start: 2014-12-28
• Study First Submitted: 2015-05-12
• Study First Submitted QC: 2015-05-12
• Study First Posted: 2015-05-15
• Primary Completion: 2016-09
• Study Completion: 2016-11-05
• Status Verified: 2019-03
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group I (aromatherapy and essential oils week 1)	Aromatherapy and Essential Oils	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 I (aromatherapy and essential oils week 1)	Questionnaire Administration	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 (aromatherapy and essential oils week 3)	Placebo	Patients undergo placebo intervention using rose water during week 1 and aromatherapy and essential oils as in Group I during week 2.
Group I (aromatherapy and essential oils week 1)	Placebo	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 (aromatherapy and essential oils week 3)	Aromatherapy and Essential Oils	Patients undergo placebo intervention using rose water during week 1 and aromatherapy and essential oils as in Group I during week 2.
Group II (aromatherapy and essential oils week 3)	Questionnaire Administration	Patients undergo placebo intervention using rose water during week 1 and aromatherapy and essential oils as in Group I during week 2.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States