Hematologic DiseasesNCT05102331
Lavender Oil Aromatherapy for The Treatment of Acute Anxiety During Bone Marrow Biopsy Procedures
A study testing Lavender Oil Aromatherapy and BMAB procedure in people with Hematologic Diseases, run by Case Comprehensive Cancer Center.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hematologic Diseases
- What is being tested?
- Lavender Oil Aromatherapy and BMAB procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2021to Aug 2022
- 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 19 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
- 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
Who cannot join
- 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
About this study
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
Read the 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.
- Conditions
- Hematologic Diseases
- Being tested
- Lavender Oil Aromatherapy, Placebo oil, BMAB procedure
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavender Oil AromatherapyOther
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
Placebo oilOther
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 procedureProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo oil; Procedure: BMAB procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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
Measured: Within fifteen minutes post-BMAB
Secondary outcomes (11)
Pain scores based on the Brief Pain Inventory Short Form (BPI-SF)
Efficacy of LOA to relieve acute pain as measured by BPI-SF scores.
Item 1: Yes/No question assessing if participants are currently experiencing pain other than minor headache, sprain, or toothache.
Item 2: Aks participants to indicate on a whole body diagram the exact location of pain.
Items 3-6: Measure severity of pain on a 0-10 numeric scale, with 0 indicating no pain and 10 indicating pain as bad as you can imagine Item 7: Asks "what treatment or medications are you receiving for your pain?" Item 8: Assesses relief from pain treatments or medications within the last 24 hours, scored by "percent of relief received" from 0% to 100%, at 10% increments, with 0% indicating no relief, and 100% indicating complete relief Item 9 includes 7 sub-ratings regarding the impact that pain within the previous 24 hours on quality of life. Each sub-rating is scored from 0 to 10 with 0 indicating that pain does not interfere, and 10 indicating pain completely interferes.
Measured: Within fifteen minutes pre-BMAB
Pain scores based on the BPI-SF
Efficacy of LOA to relieve acute pain as measured by BPI-SF scores.
Item 1: Yes/No question assessing if participants are currently experiencing pain other than minor headache, sprain, or toothache.
Item 2: Aks participants to indicate on a whole body diagram the exact location of pain.
Items 3-6: Measure severity of pain on a 0-10 numeric scale, with 0 indicating no pain and 10 indicating pain as bad as you can imagine Item 7: Asks "what treatment or medications are you receiving for your pain?" Item 8: Assesses relief from pain treatments or medications within the last 24 hours, scored by "percent of relief received" from 0% to 100%, at 10% increments, with 0% indicating no relief, and 100% indicating complete relief Item 9 includes 7 sub-ratings regarding the impact that pain within the previous 24 hours on quality of life. Each sub-rating is scored from 0 to 10 with 0 indicating that pain does not interfere, and 10 indicating pain completely interferes.
Measured: Within fifteen minutes post-BMAB
Pain scores based on Edmonton Symptom Assessment Score (ESAS)
Average pain symptom scores as measured by ESAS
The ESAS measures responses to 10 common symptoms (pain, fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, appetite, feelings of well-being, and other symptom). Participants rate the intensity of symptoms during the last 24 hours on 0 to 10 numerical scales from 0 no symptom to 10 worst possible symptoms.
Measured: Within fifteen minutes pre-BMAB
Pain scores based on ESAS
Average pain symptom scores as measured by ESAS
The ESAS measures responses to 10 common symptoms (pain, fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, appetite, feelings of well-being, and other symptom). Participants rate the intensity of symptoms during the last 24 hours on 0 to 10 numerical scales from 0 no symptom to 10 worst possible symptoms.
Measured: Within fifteen minutes post-BMAB
Anxiety scores based on ESAS
Average anxiety symptom scores as measured by ESAS
The ESAS measures responses to 10 common symptoms (pain, fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, appetite, feelings of well-being, and other symptom). Participants rate the intensity of symptoms during the last 24 hours on 0 to 10 numerical scales from 0 no symptom to 10 worst possible symptoms.
A mixed effect regression model with the anxiety scores from the ESAS will be fit to assess association between groups and outcomes. The study team will also test for time effects and for a group by time interaction effect.
Measured: Within fifteen minutes pre-BMAB
Anxiety scores based on ESAS
Average anxiety symptom scores as measured by ESAS
The ESAS measures responses to 10 common symptoms (pain, fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, appetite, feelings of well-being, and other symptom). Participants rate the intensity of symptoms during the last 24 hours on 0 to 10 numerical scales from 0 no symptom to 10 worst possible symptoms.
A mixed effect regression model with the anxiety scores from the ESAS will be fit to assess association between groups and outcomes. The study team will also test for time effects and for a group by time interaction effect.
Measured: Within fifteen minutes post-BMAB
Pre-BMAB Questionnaire
A survey will be offered to those who decline to enroll in order to further understand why they chose not to participate in the study. Survey consists of 6 likert-style questions scored from 0 to 4, with higher scores indicating more agreement with statements. Scores range from 0 to 24, with higher scores indicating more agreement with the statement.
Also includes an opportunity to list "other reasons" for not participating
Measured: Within fifteen minutes pre-BMAB
Post-BMAB Questionnaire
A survey will be offered to those who enroll on the study to fully understand their experience with LOA treatments, assess patients' satisfaction with the lavender oil treatment, if they would be interested in lavender oil for future BMA, and their experience in the clinical trial as a whole. These questions will be based on the Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General (FACIT-TS-G) questionnaire and tailored to lavender oil aromatherapy.
Survey consists of 2 sections of 4 likert-style questions (agreement and satisfaction, respectively), with each question scored from 0 to 4 (total section score ranges from 0 to 32, with higher scores indicating more agreement or satisfaction.
3 additional yes/no/maybe questions relating to whether participant experience and satisfaction follow.
One additional open-ended question leaves room fore participants to enter other comments.
Measured: Within fifteen minutes post-BMAB
Percent of patients that decline the study
Feasibility, as measure by percent of patients that decline the study
If >50% of patients agree to participate and if >50% are able to complete the lavender oil treatment, the study will be determined feasible
Measured: Within fifteen minutes pre-BMAB
Percent of participants completing the study
Completion rate, as measured by percent of participants completing the study with 95% confidence intervals, with "completion" defined as receiving lavender oil treatments as described. Each participant will be assigned one of the following categories:
- completed treatment course
- incomplete treatment course
- unknown (not assessable, insufficient data)
If >50% of patients agree to participate and if >50% are able to complete the lavender oil treatment, the study will be determined feasible
Measured: Within fifteen minutes post-BMAB
length of time of the BMAB procedure
length of time of the BMAB procedure will be compared between LOA versus SOC
Measured: Within fifteen minutes post-BMAB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study startAug 2021 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (estimated)
Why it stopped: PI leaving institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic DiseasesStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Lee, MD, Principal investigator, University Hospitals at Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102331
- Sponsor's protocol ID
- CASE4Z21
- Status last verified
- Nov 2021
- First submitted
- 20 Oct 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lavender Oil Aromatherapy for The Treatment of Acute Anxiety During Bone Marrow Biopsy Procedures
- ClinicalTrials.gov ID
- NCT05102331
- Acronym / sponsor ID
- CASE4Z21
- Conditions
- Hematologic Diseases
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI leaving institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Aug 2021 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 1 Nov 2021 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lavender Oil Aromatherapy Treatment Arm (LOA) | Experimental | Other: Lavender Oil Aromatherapy, Procedure: BMAB procedureParticipants 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. |
| Placebo Aromatherapy Control Arm (PA) | Placebo comparator | Other: Placebo oil, Procedure: BMAB procedureParticipants 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Lavender Oil AromatherapyParticipants 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 | Other | Lavender Oil Aromatherapy Treatment Arm (LOA) |
| Placebo oilParticipants 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 | Other | Placebo Aromatherapy Control Arm (PA) |
| BMAB procedureSOC 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 | Procedure or surgery | Lavender Oil Aromatherapy Treatment Arm (LOA), Placebo Aromatherapy Control Arm (PA) |
Primary outcome
Anxiety scores from post-procedure questionnaire
Time frame: Within fifteen minutes post-BMAB
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).
State-Trait Anxiety Inventory (STAI) scores - Baseline
Time frame: Within fifteen minutes pre-BMAB
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.
SAI-SF scores
Time frame: Within fifteen minutes post-BMAB
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
11 secondary outcomes
Pain scores based on the Brief Pain Inventory Short Form (BPI-SF)
Time frame: Within fifteen minutes pre-BMAB
Pain scores based on the BPI-SF
Time frame: Within fifteen minutes post-BMAB
Pain scores based on Edmonton Symptom Assessment Score (ESAS)
Time frame: Within fifteen minutes pre-BMAB
Pain scores based on ESAS
Time frame: Within fifteen minutes post-BMAB
Anxiety scores based on ESAS
Time frame: Within fifteen minutes pre-BMAB
Anxiety scores based on ESAS
Time frame: Within fifteen minutes post-BMAB
Pre-BMAB Questionnaire
Time frame: Within fifteen minutes pre-BMAB
Post-BMAB Questionnaire
Time frame: Within fifteen minutes post-BMAB
Percent of patients that decline the study
Time frame: Within fifteen minutes pre-BMAB
Percent of participants completing the study
Time frame: Within fifteen minutes post-BMAB
length of time of the BMAB procedure
Time frame: Within fifteen minutes post-BMAB
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
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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 Lee, MD principal investigator
University Hospitals at Cleveland Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Lavender Oil Aromatherapy and BMAB procedure in people with Hematologic Diseases, run by Case Comprehensive Cancer Center.
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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Anxiety scores from post-procedure questionnaire (time frame: Within fifteen minutes post-BMAB). 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 10 Nov 2021.