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Trial Title:
Aromatherapy Oil Associated for Managing Anxiety and Pain During Bone Marrow Biopsy Procedures
NCT ID:
NCT06581211
Condition:
Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Aromatherapy and Essential Oils
Description:
Inhale LA
Arm group label:
Group II (LA)
Other name:
Aromatherapy
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Ancillary studies
Arm group label:
Group I (LOA)
Arm group label:
Group II (LA)
Arm group label:
Group III (jojoba)
Intervention type:
Other
Intervention name:
Jojoba Oil
Description:
Inhale jojoba oil aromatherapy
Arm group label:
Group III (jojoba)
Intervention type:
Other
Intervention name:
Lavender Oil
Description:
Inhale LAO
Arm group label:
Group I (LOA)
Other name:
Common Lavender Oil
Other name:
English Lavender Oil
Other name:
Lavandula officinalis Flowering Top Oil
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Group I (LOA)
Arm group label:
Group II (LA)
Arm group label:
Group III (jojoba)
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Richard T. Lee
Phone:
949-671-4091
Email:
RichLee@coh.org
Contact backup:
Last name:
Richard T. Lee
Start date:
August 23, 2024
Completion date:
December 25, 2028
Lead sponsor:
Agency:
City of Hope Medical Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
City of Hope Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06581211
