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Completed

NCT Number: NCT02445378

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aromatherapy and Essential Oils

Procedure

Undergo aromatherapy and essential oils

Other names: Aromatherapy

Placebo

Other

Undergo placebo intervention using rose water

Other names: placebo therapy, PLCB, sham therapy

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 15, 2015
Registry last updated
Apr 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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