Aromatherapy Oil Associated for Managing Anxiety and Pain During Bone Marrow Biopsy Procedures

Aromatherapy Oil Associated Changes on Anxiety and Pain During Bone Marrow Biopsy Procedures

This clinical trial evaluates whether using aromatherapy can reduce pain and anxiety for cancer patients during routine biopsy procedures. Because of the discomfort associated with a bone marrow aspirate and biopsy (BMAB), many patients have significant anxiety in addition to their pain. With the current background of the opioid crisis, researchers have been looking for different ways to treat pain and anxiety in cancer patients without using medications that have a risk for abuse. Recent research suggests that using lavender aromatherapy may be an effective and more affordable treatment for anxiety and pain in patients. Information gathered from this study may help researchers determine whether using aromatherapy may help to manage pain and anxiety during biopsy procedures for cancer patients.

Study Overview

• Status: Suspended
• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Other: Electronic Health Record Review; Other: Lavender Oil; Procedure: Aromatherapy and Essential Oils; Other: Jojoba Oil

Detailed Description

PRIMARY OBJECTIVES:

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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope Medical Center
    • Irvine, California, United States, 92618
      • City of Hope at Lennar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients must have the ability to understand and sign a written informed consent document, and be willing to follow protocol requirements
• 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:

• Allergy to lavender oil, linalool oil, jojoba oil
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I (LOA); Patients inhale LOA for 20 minutes prior to SOC BMAB and throughout the procedure.	Other: Questionnaire Administration; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; Other: Lavender Oil; Inhale LAO; Other Names: Common Lavender Oil; English Lavender Oil; Lavandula officinalis Flowering Top Oil
Experimental: Group II (LA); GROUP II: Patients inhale LA for 20 minutes prior to SOC BMAB and throughout the procedure.	Other: Questionnaire Administration; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; Procedure: Aromatherapy and Essential Oils; Inhale LA; Other Names: Aromatherapy
Placebo Comparator: Group III (jojoba); Patients inhale jojoba oil for 20 minutes prior to SOC BMAB.	Other: Questionnaire Administration; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; Other: Jojoba Oil; Inhale jojoba oil aromatherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients participated in the aromatherapy oils (Feasibility)	Will consider the study feasible if > 70% of patients are able to complete the oil treatment (lavender, linalool or placebo). Will be estimated within 95% confidence interval.	Up to 1 month
Proportion of patients completed the aromatherapy oils (Feasibility)	Completion will be defined as receiving oil treatments as described. Each patient will be assigned one of the following categories: 1) complete treatment course, 2) incomplete treatment course, or 3) unknown (not assessable, insufficient data). Will be estimated within 95% confidence interval.	Up to 1 month
Patient satisfaction	Will be evaluated using a survey, in order to fully understand their experience with the treatment. Will also evaluate whether the patients are interested in aromatherapy oils for future bone marrow aspiration and biopsy (BMAB), and their experience in the clinical trial. Descriptive analyses (exploratory) will be provided for all individual assessment items.	One time patient satisfaction assessment within 30 minutes after bone marrow aspiration and biopsy (BMAB).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between aromatherapy and other symptoms	Will be compared (to placebo aromatherapy) using the ESAS scores for the remaining symptoms via the mixed effect modeling approach. For individual scores, research indicates a change of 1.0-1.5 correlates with a minimal clinically important difference.	The 3 time points are: at baseline before oil administration; after oil administration before BMAB; after BMAB up to 24 hours
Association between aromatherapy and anxiety	We will compare differences in anxiety scores between each intervention aromatherapy group (Lavender, Linalool) and Placebo (Jojoba) using independent sample t-test (or Mann-Whitney test). We will assess anxiety scores from the ESAS form, within and between groups, at three specific assessment points (pre-BMAB, post-relaxation, and post-BMAB) via mixed effect regression models (which will account for the correlation between observations on the same patient). We will test for time, and group by time interaction effects.	The 3 time points are: at baseline before oil administration; after oil administration before BMAB; after BMAB up to 24 hours
Clinician's responses	Will be assessed using the post-procedure questionnaire. Descriptive analyses will be produced (by group). Furthermore, independent samples t-tests will be applied to determine if there are any differences in practitioner procedure evaluation questions between the two groups.	At post-BMAB up to 24 hours
Association between aromatherapy and pain	Will be compared (to placebo aromatherapy) using scores from the pain question of the ESAS. Will also use the Brief Pain Inventory Short Form total score. A statistical analysis similar to the comparison in anxiety scores will be performed.	The 3 time points are: at baseline before oil administration; after oil administration before BMAB; after BMAB up to 24 hours

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Richard T Lee, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2024
• Primary Completion (Estimated): June 25, 2026
• Study Completion (Estimated): June 25, 2026

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Estimated): November 6, 2025
• Last Update Submitted That Met QC Criteria: November 4, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Therapeutics; Mind-Body Therapies; Complementary Therapies; Psychotherapy; Behavioral Disciplines and Activities; Sensory Art Therapies; Phytotherapy; Aromatherapy; jojoba wax; lavender oil
• Other Study ID Numbers: 23234 (Other Identifier: City of Hope Medical Center); P30CA033572 (U.S. NIH Grant/Contract); NCI-2024-05514 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No