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

Not Applicable

Recruiting

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

• Registration Number: NCT06581211
• Lead Sponsor: City of Hope Medical Center

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-07-16
• Status Verified: 2024-08
• Study Start: 2024-08-23
• Study First Submitted QC: 2024-08-29
• Last Update Submitted: 2024-08-29
• Study First Posted: 2024-09-03
• Last Update Posted: 2024-09-03
• Primary Completion: 2028-12-25
• Study Completion: 2028-12-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group III (jojoba)	Questionnaire Administration	Patients inhale jojoba oil for 20 minutes prior to SOC BMAB.
Group I (LOA)	Electronic Health Record Review	Patients inhale LOA for 20 minutes prior to SOC BMAB and throughout the procedure.
Group I (LOA)	Lavender Oil	Patients inhale LOA for 20 minutes prior to SOC BMAB and throughout the procedure.
Group I (LOA)	Questionnaire Administration	Patients inhale LOA for 20 minutes prior to SOC BMAB and throughout the procedure.
Group II (LA)	Aromatherapy and Essential Oils	GROUP II: Patients inhale LA for 20 minutes prior to SOC BMAB and throughout the procedure.
Group II (LA)	Electronic Health Record Review	GROUP II: Patients inhale LA for 20 minutes prior to SOC BMAB and throughout the procedure.
Group II (LA)	Questionnaire Administration	GROUP II: Patients inhale LA for 20 minutes prior to SOC BMAB and throughout the procedure.
Group III (jojoba)	Electronic Health Record Review	Patients inhale jojoba oil for 20 minutes prior to SOC BMAB.
Group III (jojoba)	Jojoba Oil	Patients inhale jojoba oil for 20 minutes prior to SOC BMAB.

Primary Outcome Measures

Name	Time	Method
Proportion of patients participated in the aromatherapy oils (Feasibility)	Up to 1 month	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.
Proportion of patients completed the aromatherapy oils (Feasibility)	Up to 1 month	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.
Patient satisfaction	One time patient satisfaction assessment within 30 minutes after bone marrow aspiration and biopsy (BMAB).	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.

Secondary Outcome Measures

Name	Time	Method
Association between aromatherapy and other symptoms	The 3 time points are: at baseline before oil administration; after oil administration before BMAB; after BMAB up to 24 hours	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.
Association between aromatherapy and anxiety	The 3 time points are: at baseline before oil administration; after oil administration before BMAB; after BMAB up to 24 hours	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.
Clinician's responses	At post-BMAB up to 24 hours	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.
Association between aromatherapy and pain	The 3 time points are: at baseline before oil administration; after oil administration before BMAB; after BMAB up to 24 hours	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.

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States