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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02445378
• Other study ID #: OSU-14182
• Secondary ID: NCI-2015-00549
• Status: Completed
• Phase: N/A
• Start date: December 28, 2014
• Est. completion date: November 5, 2016

Study information

• Verified date: March 2019
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 5, 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Disease
• Acute Leukemia
• Anorexia
• Anxiety
• Depression
• Dyspnea
• Insomnia
• Leukemia
• Nausea
• Pain
• Sleep Initiation and Maintenance Disorders

Intervention

Procedure:
• Aromatherapy and Essential Oils
Undergo aromatherapy and essential oils

Other:
• Placebo
Undergo placebo intervention using rose water
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Rate of positive experience with aromatherapy		Up to 2 weeks

External Links

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