Clinical trial NCT06581211: Aromatherapy Oil Associated for Managing Anxiety and Pain During Bone Marrow Biopsy Procedures
Official title: Aromatherapy Oil Associated Changes on Anxiety and Pain During Bone Marrow Biopsy Procedures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-09-03
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients participated in the aromatherapy oils (Feasibility)
timeFrame: Up to 1 month
measure: Proportion of patients completed the aromatherapy oils (Feasibility)
timeFrame: Up to 1 month
measure: Patient satisfaction
timeFrame: One time patient satisfaction assessment within 30 minutes after bone marrow aspiration and biopsy (BMAB).
Secondary outcomes:
measure: Association between aromatherapy and other symptoms
timeFrame: The 3 time points are: at baseline before oil administration; after oil administration before BMAB; after BMAB up to 24 hours
measure: Association between aromatherapy and anxiety
timeFrame: The 3 time points are: at baseline before oil administration; after oil administration before BMAB; after BMAB up to 24 hours
measure: Clinician's responses
timeFrame: At post-BMAB up to 24 hours
measure: Association between aromatherapy and pain
timeFrame: The 3 time points are: at baseline before oil administration; after oil administration before BMAB; after BMAB up to 24 hours
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Richard T Lee
role: PRINCIPAL_INVESTIGATOR
References: