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Trial record 25 of 238 for:    essential oil

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

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ClinicalTrials.gov Identifier: NCT02445378
Recruitment Status : Completed
First Posted : May 15, 2015
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Lisa Blackburn, 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.

Condition or disease Intervention/treatment Phase
Acute Leukemia Anorexia Anxiety Depression Dyspnea Insomnia Nausea Pain Procedure: Aromatherapy and Essential Oils Other: Placebo Other: Questionnaire Administration Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: The Effect of Aromatherapy on Insomnia and Other Common Cancer Patient Symptoms
Actual Study Start Date : December 28, 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : November 5, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arm Intervention/treatment
Experimental: Group I (aromatherapy and essential oils week 1)
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.
Procedure: Aromatherapy and Essential Oils
Undergo aromatherapy and essential oils
Other Name: Aromatherapy

Other: Placebo
Undergo placebo intervention using rose water
Other Names:
  • placebo therapy
  • PLCB
  • sham therapy

Other: Questionnaire Administration
Ancillary studies

Experimental: Group II (aromatherapy and essential oils week 3)
Patients undergo placebo intervention using rose water during week 1 and aromatherapy and essential oils as in Group I during week 2.
Procedure: Aromatherapy and Essential Oils
Undergo aromatherapy and essential oils
Other Name: Aromatherapy

Other: Placebo
Undergo placebo intervention using rose water
Other Names:
  • placebo therapy
  • PLCB
  • sham therapy

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Improvement of Insomnia graded by Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 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 :
  1. 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 ]
  2. Rate of positive experience with aromatherapy [ Time Frame: Up to 2 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02445378


Locations
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United States, Ohio
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
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Principal Investigator: Lisa Blackburn, MS,RN,AOCNS Ohio State University Comprehensive Cancer Center

Additional Information:
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Responsible Party: Lisa Blackburn, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02445378     History of Changes
Other Study ID Numbers: OSU-14182
NCI-2015-00549 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: March 2019
Keywords provided by Lisa Blackburn, Ohio State University Comprehensive Cancer Center:
Aromatherapy
essential oils
Acute Leukemia
Additional relevant MeSH terms:
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Leukemia
Dyspnea
Sleep Initiation and Maintenance Disorders
Anorexia
Acute Disease
Neoplasms by Histologic Type
Neoplasms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Disease Attributes
Pathologic Processes