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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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