Aromatherapy Oil Associated for Managing Anxiety and Pain During Bone Marrow Biopsy Procedures
NCT Number: NCT06581211
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hematopoietic and Lymphatic System Neoplasm|Malignant Solid Neoplasm
Sponsor: City of Hope Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-23
Completion Date: 2028-12-25

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.

Primary Outcome Measures: 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: 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