Hematopoietic and Lymphatic System NeoplasmNCT06581211
Aromatherapy Oil Associated for Managing Anxiety and Pain During Bone Marrow Biopsy Procedures
A study testing Aromatherapy and Essential Oils, Electronic Health Record Review and Jojoba Oil in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by City of Hope Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Aromatherapy and Essential Oils, Electronic Health Record Review and Jojoba Oil
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Aug 2024to 22 Apr 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
City of Hope Medical Center
Duarte, California, 91010
City of Hope at Lennar
Irvine, California, 92618
About this study
Official title: Aromatherapy Oil Associated Changes on Anxiety and Pain During Bone Marrow Biopsy Procedures
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Being tested
- Aromatherapy and Essential Oils, Electronic Health Record Review, Jojoba Oil, Lavender Oil, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aromatherapy and Essential OilsProcedure or surgery
Also called Aromatherapy
Inhale LA
Electronic Health Record ReviewOther
Ancillary studies
Jojoba OilOther
Inhale jojoba oil aromatherapy
Lavender OilOther
Also called Common Lavender Oil, English Lavender Oil, Lavandula officinalis Flowering Top Oil
Inhale LAO
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (LOA) | Experimental | Patients inhale LOA for 20 minutes prior to SOC BMAB and throughout the procedure. Receives: Other: Electronic Health Record Review; Other: Lavender Oil; Other: Questionnaire Administration |
| Group II (LA) | Experimental | GROUP II: Patients inhale LA for 20 minutes prior to SOC BMAB and throughout the procedure. Receives: Procedure: Aromatherapy and Essential Oils; Other: Electronic Health Record Review; Other: Questionnaire Administration |
| Group III (jojoba) | Placebo comparator | Patients inhale jojoba oil for 20 minutes prior to SOC BMAB. Receives: Other: Electronic Health Record Review; Other: Jojoba Oil; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: One time patient satisfaction assessment within 30 minutes after bone marrow aspiration and biopsy (BMAB).
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The 3 time points are: at baseline before oil administration; after oil administration before BMAB; after BMAB up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start28 Aug 2024
- Primary completion22 Apr 2027 (estimated)
- Study completion22 Apr 2027 (estimated)
Why it stopped: Accrual goal met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Richard T Lee, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581211
- Sponsor's protocol ID
- 23234
- Other IDs
- P30CA033572, NCI-2024-05514, 23234
- Status last verified
- Oct 2026
- First submitted
- 16 Jul 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aromatherapy Oil Associated Changes on Anxiety and Pain During Bone Marrow Biopsy Procedures
- ClinicalTrials.gov ID
- NCT06581211
- Acronym / sponsor ID
- 23234
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Accrual goal met
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 28 Aug 2024 (actual)
- Primary completion
- 22 Apr 2027 (estimated)
- Study completion
- 22 Apr 2027 (estimated)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (LOA) | Experimental | Other: Electronic Health Record Review, Other: Lavender Oil, Other: Questionnaire AdministrationPatients inhale LOA for 20 minutes prior to SOC BMAB and throughout the procedure. |
| Group II (LA) | Experimental | Procedure: Aromatherapy and Essential Oils, Other: Electronic Health Record Review, Other: Questionnaire AdministrationGROUP II: Patients inhale LA for 20 minutes prior to SOC BMAB and throughout the procedure. |
| Group III (jojoba) | Placebo comparator | Other: Electronic Health Record Review, Other: Jojoba Oil, Other: Questionnaire AdministrationPatients inhale jojoba oil for 20 minutes prior to SOC BMAB. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aromatherapy and Essential OilsAlso: AromatherapyInhale LA | Procedure or surgery | Group II (LA) |
| Electronic Health Record ReviewAncillary studies | Other | Group I (LOA), Group II (LA), Group III (jojoba) |
| Jojoba OilInhale jojoba oil aromatherapy | Other | Group III (jojoba) |
| Lavender OilAlso: Common Lavender Oil, English Lavender Oil, Lavandula officinalis Flowering Top OilInhale LAO | Other | Group I (LOA) |
| Questionnaire AdministrationAncillary studies | Other | Group I (LOA), Group II (LA), Group III (jojoba) |
Primary outcome
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.
4 secondary outcomes
Association between aromatherapy and other symptoms
Time frame: 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
Time frame: The 3 time points are: at baseline before oil administration; after oil administration before BMAB; after BMAB up to 24 hours
Clinician's responses
Time frame: At post-BMAB up to 24 hours
Association between aromatherapy and pain
Time frame: The 3 time points are: at baseline before oil administration; after oil administration before BMAB; after BMAB up to 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard T Lee principal investigator
City of Hope Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy and Essential Oils, Electronic Health Record Review and Jojoba Oil in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by City of Hope Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients participated in the aromatherapy oils (Feasibility) (time frame: Up to 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.