Clinical trial NCT05102331: Lavender Oil Aromatherapy for The Treatment of Acute Anxiety During Bone Marrow Biopsy Procedures
Official title: Lavender Oil Aromatherapy for The Treatment of Acute Anxiety During Bone Marrow Biopsy Procedures
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hematologic Diseases
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: Bone marrow aspiration and biopsy (BMAB) is a primarily outpatient procedure that is used to aid the diagnosis of hematological diseases. During the BMAB, local anesthesia is used however, many recipients still commonly report pain. Poorly-controlled pain has been shown to have adverse, long-lasting psychological effects and those receiving BMAB are generally significantly anxious and concerned about pain when undergoing this procedure. Previous clinical studies suggest that lavender oil aromatherapy is effective in lowering anxiety experienced by participants. It will be hypothesized that lavender oil aromatherapy will demonstrate benefit to participants suffering from anxiety during the BMAB procedure.

Participants who are undergoing BMAB and meet the inclusion criteria will be randomized to either receive aromatherapy via lavender oil before and during the duration of the BMAB, or to a SOC arm.

The primary objective of this study is to assess the efficacy of lavender oil aromatherapy as compared to placebo aromatherapy to relieve acute anxiety in participants undergoing a BMAB procedure

Secondary objectives of this study are:

To assess the efficacy of lavender oil aromatherapy as compared to placebo aromatherapy to relieve acute anxiety in participants undergoing a BMAB procedure

To determine the feasibility of utilizing lavender oil aromatherapy during BMAB in clinical practice.

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
* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Anxiety scores from post-procedure questionnaire
timeFrame: Within fifteen minutes post-BMAB
measure: State-Trait Anxiety Inventory (STAI) scores - Baseline
timeFrame: Within fifteen minutes pre-BMAB
measure: SAI-SF scores
timeFrame: Within fifteen minutes post-BMAB
Secondary outcomes:
measure: Pain scores based on the Brief Pain Inventory Short Form (BPI-SF)
timeFrame: Within fifteen minutes pre-BMAB
measure: Pain scores based on the BPI-SF
timeFrame: Within fifteen minutes post-BMAB
measure: Pain scores based on Edmonton Symptom Assessment Score (ESAS)
timeFrame: Within fifteen minutes pre-BMAB
measure: Pain scores based on ESAS
timeFrame: Within fifteen minutes post-BMAB
measure: Anxiety scores based on ESAS
timeFrame: Within fifteen minutes pre-BMAB
measure: Anxiety scores based on ESAS
timeFrame: Within fifteen minutes post-BMAB
measure: Pre-BMAB Questionnaire
timeFrame: Within fifteen minutes pre-BMAB
measure: Post-BMAB Questionnaire
timeFrame: Within fifteen minutes post-BMAB
measure: Percent of patients that decline the study
timeFrame: Within fifteen minutes pre-BMAB
measure: Percent of participants completing the study
timeFrame: Within fifteen minutes post-BMAB
measure: length of time of the BMAB procedure
timeFrame: Within fifteen minutes post-BMAB
Other outcomes:
Locations:
Study officials:
affiliation: University Hospitals at Cleveland Medical Center
name: Richard Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: