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

NCT ID: NCT02445378

Last Updated: 2019-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-28

Study Completion Date

2016-11-05

Brief Summary

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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

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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.

Conditions

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Acute Leukemia Anorexia Anxiety Depression Dyspnea Insomnia Nausea Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Aromatherapy and Essential Oils

Intervention Type PROCEDURE

Undergo aromatherapy and essential oils

Placebo

Intervention Type OTHER

Undergo placebo intervention using rose water

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type EXPERIMENTAL

Aromatherapy and Essential Oils

Intervention Type PROCEDURE

Undergo aromatherapy and essential oils

Placebo

Intervention Type OTHER

Undergo placebo intervention using rose water

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Aromatherapy and Essential Oils

Undergo aromatherapy and essential oils

Intervention Type PROCEDURE

Placebo

Undergo placebo intervention using rose water

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Aromatherapy placebo therapy PLCB sham therapy

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Lisa Blackburn

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lisa Blackburn, MS,RN,AOCNS

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

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Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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NCI-2015-00549

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-14182

Identifier Type: -

Identifier Source: org_study_id

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