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

NCT ID: NCT05102331

Last Updated: 2021-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-31

Study Completion Date

2022-08-31

Brief Summary

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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

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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.

Conditions

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Hematologic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Lavender Oil Aromatherapy Treatment Arm (LOA)

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.

Group Type EXPERIMENTAL

Lavender Oil Aromatherapy

Intervention Type 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

BMAB procedure

Intervention Type 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

Placebo Aromatherapy Control Arm (PA)

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.

Group Type PLACEBO_COMPARATOR

Placebo oil

Intervention Type 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

BMAB procedure

Intervention Type 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

Interventions

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Lavender Oil Aromatherapy

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

Intervention Type OTHER

Placebo oil

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

Intervention Type OTHER

BMAB 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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Case Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Lee, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals at Cleveland Medical Center

Other Identifiers

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CASE4Z21

Identifier Type: -

Identifier Source: org_study_id