NCT02445378

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 28, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 15, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2016

Completed
Last Updated

April 5, 2019

Status Verified

March 1, 2019

Enrollment Period

1.7 years

First QC Date

May 12, 2015

Last Update Submit

April 3, 2019

Conditions

Acute LeukemiaAnorexiaAnxietyDepressionDyspneaInsomniaNauseaPain

Keywords

Aromatherapyessential oilsAcute Leukemia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

  • Rate of positive experience with aromatherapy

    Up to 2 weeks

Study Arms (2)

Group I (aromatherapy and essential oils week 1)

EXPERIMENTAL

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 OilsOther: PlaceboOther: Questionnaire Administration

Group II (aromatherapy and essential oils week 3)

EXPERIMENTAL

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 OilsOther: PlaceboOther: Questionnaire Administration

Interventions

Aromatherapy and Essential OilsPROCEDURE

Undergo aromatherapy and essential oils

Also known as: Aromatherapy
Group I (aromatherapy and essential oils week 1)Group II (aromatherapy and essential oils week 3)
PlaceboOTHER

Undergo placebo intervention using rose water

Also known as: placebo therapy, PLCB, sham therapy
Group I (aromatherapy and essential oils week 1)Group II (aromatherapy and essential oils week 3)
Questionnaire AdministrationOTHER

Ancillary studies

Group I (aromatherapy and essential oils week 1)Group II (aromatherapy and essential oils week 3)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are newly diagnosed with acute leukemia and hospitalized to receive their initial 4 weeks of intensive induction chemotherapy for this disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

MeSH Terms

Conditions

AnorexiaAnxiety DisordersDepressionDyspneaSleep Initiation and Maintenance DisordersNauseaPain

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehavioral SymptomsBehaviorRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesNeurologic Manifestations

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPhytotherapySensory Art TherapiesPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Lisa Blackburn, MS,RN,AOCNS

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 12, 2015

First Posted

May 15, 2015

Study Start

December 28, 2014

Primary Completion

September 1, 2016

Study Completion

November 5, 2016

Last Updated

April 5, 2019

Record last verified: 2019-03

Locations

US(1)