Aromatherapy and Essential Oils in Improving Insomnia and Other Symptoms in Patients With Newly Diagnosed Acute Leukemia Undergoing Chemotherapy
Primary Purpose
Acute Leukemia, Anorexia, Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aromatherapy and Essential Oils
Placebo
Questionnaire Administration
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Leukemia focused on measuring Aromatherapy, essential oils, Acute Leukemia
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
Sites / Locations
- Ohio State University Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group I (aromatherapy and essential oils week 1)
Group II (aromatherapy and essential oils week 3)
Arm 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.
Patients undergo placebo intervention using rose water during week 1 and aromatherapy and essential oils as in Group I during week 2.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
Rate of positive experience with aromatherapy
Full Information
NCT ID
NCT02445378
First Posted
May 12, 2015
Last Updated
April 3, 2019
Sponsor
Ohio State University Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT02445378
Brief Title
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
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
December 28, 2014 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
November 5, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Leukemia, Anorexia, Anxiety, Depression, Dyspnea, Insomnia, Nausea, Pain
Keywords
Aromatherapy, essential oils, Acute Leukemia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I (aromatherapy and essential oils week 1)
Arm Type
Experimental
Arm 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.
Arm Title
Group II (aromatherapy and essential oils week 3)
Arm Type
Experimental
Arm Description
Patients undergo placebo intervention using rose water during week 1 and aromatherapy and essential oils as in Group I during week 2.
Intervention Type
Procedure
Intervention Name(s)
Aromatherapy and Essential Oils
Other Intervention Name(s)
Aromatherapy
Intervention Description
Undergo aromatherapy and essential oils
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
placebo therapy, PLCB, sham therapy
Intervention Description
Undergo placebo intervention using rose water
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Improvement of Insomnia graded by Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
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)
Time Frame
Baseline to 2 weeks
Title
Rate of positive experience with aromatherapy
Time Frame
Up to 2 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Blackburn, MS,RN,AOCNS
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Links:
URL
http://cancer.osu.edu
Description
The Jamesline
Learn more about this trial
Aromatherapy and Essential Oils in Improving Insomnia and Other Symptoms in Patients With Newly Diagnosed Acute Leukemia Undergoing Chemotherapy
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