Lavender Oil Aromatherapy for The Treatment of Acute Anxiety During Bone Marrow Biopsy Procedures

NCT05102331 | Withdrawn

• 1 other identifier: CASE4Z21
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the effectiveness of lavender oil as compared to standard of care (SOC) to relieve anxiety in participants undergoing a bone marrow aspirate and biopsy procedure

Conditions

Hematologic Diseases

Outcome Measures

Primary Outcomes (3)

• Anxiety scores from post-procedure questionnaire

  Efficacy of LOA as compared to SOC to relieve acute anxiety in participants undergoing a BMAB procedure will be assessed by comparing anxiety scores from a post-procedure questionnaire that asks "What was the highest level of anxiety that you experienced during the procedure?" The primary analysis will compare difference scores from this anxiety score between the two groups using the Wilcoxon-Mann-Whitney test (Higher the score more is the anxiety).

  Within fifteen minutes post-BMAB

• State-Trait Anxiety Inventory (STAI) scores - Baseline

  The STAI measure one's conscious awareness at two extremes of anxiety affect, labeled state anxiety (A-state), and trait anxiety (A-trait), respectively. The STAI includes 20 questions about how the participant is feeling (e.g. I feel worried), each ranging from 1 to 4, with 1 indicating "not at all" and 4 indicating "very much so". Full scale ranges from 40 to 160, with higher STAI scores suggesting higher levels of anxiety. This study will use STAI at baseline and then the state anxiety inventory short form (SAI-SF) for the subsequent time points.

  Within fifteen minutes pre-BMAB

• SAI-SF scores

  The SAI-SF utilizes six questions from the STAI state questionnaire to assess state anxiety and has shown similar results to the full form. Scores range from 6 to 24, with higher scores indicating worse anxiety. Questions relate to feeling: calm, tense, upset, relaxed, content and worried

  Within fifteen minutes post-BMAB

Secondary Outcomes (11)

• Pain scores based on the Brief Pain Inventory Short Form (BPI-SF)

  Within fifteen minutes pre-BMAB

• Pain scores based on the BPI-SF

  Within fifteen minutes post-BMAB

• Pain scores based on Edmonton Symptom Assessment Score (ESAS)

  Within fifteen minutes pre-BMAB

• Pain scores based on ESAS

  Within fifteen minutes post-BMAB

• Anxiety scores based on ESAS

  Within fifteen minutes pre-BMAB

Study Arms (2)

Lavender Oil Aromatherapy Treatment Arm (LOA)

EXPERIMENTAL

Participants will complete baseline assessments including 20 minutes of questionnaires and vitals assessment, including EEG activity (baseline measured with Bispectral Index (BIS) device). Participants will be given a dental bib with three lavender oil drops and instructed to relax for 20 minutes. BP and a brief self-report measure will be obtained. BIS recordings will be collected continuously during study and biopsy. At procedure, participants will continue to wear bib with drops. BIS machine will stay attached and recording. Participants will be asked to verbally report pain and anxiety on visual analogue scale between the bone marrow aspirate and biopsy. EEG and heart rate (HR) will be collected continuously. An event marker and notation will indicate times when participant does something that may influence EEG activity (e.g. speak, move, etc.) or diagnostic images are taken. At procedure end, BIS device will be removed, final questionnaires administered, and vitals measured.

Other: Lavender Oil Aromatherapy; Procedure: BMAB procedure

Placebo Aromatherapy Control Arm (PA)

PLACEBO COMPARATOR

Participants assigned to PA Clinic staff will have the same procedures as listed in LOA arm except the oil used will be a refined jojoba oil which has no color or smell. The BMAB procedure will follow the SOC provided by the clinic. This includes warning participants of upcoming stimuli, encouraging patients to remain calm, and generally expressing empathy to participants. Participants in this group will receive the same collection of questionnaires before, during, and after the procedure as the LOA group. BP, HR, and EEG measurements will similarly be collected continuously before, during, and after the procedure.

Other: Placebo oil; Procedure: BMAB procedure

Interventions

Lavender Oil Aromatherapy OTHER

Participants will be given a dental bib to wear. Three drops of the lavender oil will be placed on the fabric of the bib and the participant will be instructed to relax for 20 minutes. The lavender oil is produced by doTERRA and has Gas Chromatography Mass Spectrometry analysis showing 35.66% linalool without any contaminants

Lavender Oil Aromatherapy Treatment Arm (LOA)

Placebo oil OTHER

Participants will be given a dental bib to wear. Three drops of the placebo oil will be placed on the fabric of the bib and the participant will be instructed to relax for 20 minutes. Refined jojoba oil which has no color or smell

Placebo Aromatherapy Control Arm (PA)

BMAB procedure PROCEDURE

SOC BMAB procedure. The procedure takes approximately 20 minutes to complete and is performed on the posterior superior iliac crest of the pelvic bone. Between 5 and 10 mL of 1% lidocaine will be injected into the site of the BMAB 5 minutes prior to the procedure beginning. No systemic premedications will be allowed including opioids or benzodiazepines. If during the procedure, participants continue to report severe anxiety or pain, the practitioner may consider providing 1mg of lorazepam or morphine as a rescue medication. The aspirate needle and core biopsy needle will be the standard needle provided by the BMAB kit

Lavender Oil Aromatherapy Treatment Arm (LOA); Placebo Aromatherapy Control Arm (PA)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have the ability to understand and sign a written informed consent document, and be willing to follow protocol requirements
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
• Willingness to comply with all study interventions of lavender oil aromatherapy
• Anxiety \>3 on a 0-10 visual analog scale regarding the bone marrow biopsy/aspirate procedure

You may not qualify if:

• Allergy to lavender oil
• 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.
• Currently pregnant
• Recent changes in the past 2 weeks to medications prescribed for pain or anxiety

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

MeSH Terms

Conditions

Hematologic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Officials

• Richard Lee, MD

  University Hospitals at Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 1, 2021
• Study Start: August 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: November 10, 2021

Record last verified: 2021-11