Aromatherapy Oil Associated for Managing Anxiety and Pain During Bone Marrow Biopsy Procedures
NCT ID: NCT06581211
Last Updated: 2025-11-06
Study Results
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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SUSPENDED
NA
45 participants
INTERVENTIONAL
2024-08-23
2026-06-25
Brief Summary
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Detailed Description
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I. To determine the feasibility of utilizing aromatherapy oils during bone marrow biopsy procedures in clinical practice.
II. To assess satisfaction of patients receiving aromatherapy oils during bone marrow biopsy procedures in clinical practice.
SECONDARY OBJECTIVES:
I. To observe the relationship of aromatherapy oils (as compared to placebo aromatherapy) on anxiety in patients undergoing a bone marrow aspirate and biopsy procedure.
II. To observe the relationship of aromatherapy oils (as compared to placebo aromatherapy) on pain in patients undergoing a bone marrow aspirate and biopsy procedure.
III. To observe the relationship of aromatherapy oils (versus placebo aromatherapy) on other symptoms (i.e., physical, emotional symptoms, etc.).
IV. Additionally assess if there are any differences in practitioner procedure evaluation between the groups.
OUTLINE: Patients are randomized to 1 of 3 groups.
GROUP I: Patients inhale lavender oil aromatherapy (LAO) for 20 minutes prior to standard of care (SOC) BMAB and throughout the procedure.
GROUP II: Patients inhale linalool oil aromatherapy (LA) for 20 minutes prior to SOC BMAB and throughout the procedure.
GROUP III: Patients inhale jojoba oil aromatherapy for 20 minutes prior to SOC BMAB.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group I (LOA)
Patients inhale LOA for 20 minutes prior to SOC BMAB and throughout the procedure.
Electronic Health Record Review
Ancillary studies
Lavender Oil
Inhale LAO
Questionnaire Administration
Ancillary studies
Group II (LA)
GROUP II: Patients inhale LA for 20 minutes prior to SOC BMAB and throughout the procedure.
Aromatherapy and Essential Oils
Inhale LA
Electronic Health Record Review
Ancillary studies
Questionnaire Administration
Ancillary studies
Group III (jojoba)
Patients inhale jojoba oil for 20 minutes prior to SOC BMAB.
Electronic Health Record Review
Ancillary studies
Jojoba Oil
Inhale jojoba oil aromatherapy
Questionnaire Administration
Ancillary studies
Interventions
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Aromatherapy and Essential Oils
Inhale LA
Electronic Health Record Review
Ancillary studies
Jojoba Oil
Inhale jojoba oil aromatherapy
Lavender Oil
Inhale LAO
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability to read and understand English for patient reported outcomes
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
* Willingness to comply with all study interventions of essential oil aromatherapy
* Anxiety \> 3 on a 0-10 visual analog scale regarding the bone marrow biopsy/aspirate procedure
* The study is open to all participants regardless of gender, race, or ethnicity
Exclusion Criteria
* Previous enrollment in this study
* Uncontrolled respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD)
* Mental incapacitation (ex. stroke, brain metastasis etc.) that would cause inability to follow directions, in the opinion of the investigators
* Ongoing uncontrolled active psychiatric condition that would interfere in the conduct of the study (e.g., mood disorders, anxiety, psychosis disorders, or substance use), as determined by the patient's primary cancer team.
* If a patient has a history of a psychiatric disorder, we will contact their primary cancer team to determine if their condition is controlled or uncontrolled, and if it will interfere with the study
* Recent changes in the past 2 weeks to medications prescribed for pain or anxiety
* Abnormal smelling abilities due to sinus infections, long COVID, etc.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Richard T Lee
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
City of Hope at Lennar
Irvine, California, United States
Countries
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Other Identifiers
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NCI-2024-05514
Identifier Type: REGISTRY
Identifier Source: secondary_id
23234
Identifier Type: OTHER
Identifier Source: secondary_id
23234
Identifier Type: -
Identifier Source: org_study_id