Aromatherapy Oil Associated Changes on Anxiety and Pain During Bone Marrow Biopsy Procedures
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hematopoietic and Lymphatic System Neoplasm
- Sponsor
- City of Hope Medical Center
- Enrollment
- 45
- Locations
- 2
- Primary Endpoint
- Proportion of patients participated in the aromatherapy oils (Feasibility)
- Status
- Suspended
- Last Updated
- 5 months ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Proportion of patients participated in the aromatherapy oils (Feasibility)
Time Frame: 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)
Time Frame: 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
Time Frame: 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 Outcomes
- 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)
- 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)
- Clinician's responses(At post-BMAB up to 24 hours)
- 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)