Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06581211
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Aromatherapy Oil Associated for Managing Anxiety and Pain During Bone Marrow Biopsy Procedures
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Aromatherapy Oil Associated Changes on Anxiety and Pain During Bone Marrow Biopsy Procedures
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
I 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
I 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 ie 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
I 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
I 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None