Back to resultsAromatherapy and Anxiety Study
Primary Purpose
Anxiety Related to Pain Related to an Intraarticular Injection, Pain Related to an Intraarticular Injection
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guided Meditation
Aromatherapy
Sponsored by
About this trial
This is an interventional health services research trial for Anxiety Related to Pain Related to an Intraarticular Injection
Eligibility Criteria
Inclusion Criteria: Patient has an in-office appointment at the NYU Langone Ambulatory Care-23rd Street location with either the Ortho A & B (primarily those patients who may be seeking knee or hip replacement surgery), Hand, or Primary Sport clinics. Patient has an order for an intra-articular injection (as determined by clinic MD) and has consented to receiving that treatment. Patient is English speaking. Exclusion Criteria: Patient has a cognitive or physical disability that would interfere with their ability to complete the study's pre and post assessments with RN. Patient is found on the pre-injection assessment form to have an intolerance or allergy to lavender, sandalwood, or strong scents in general.
Sites / Locations
- NYU Langone HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control
Experimental Group A
Experimental Group B
Arm Description
Participants in the control arm will receive the current standard of nursing care for treating anxiety prior to receiving the intra-articular injection (emotional support, distraction, and/or therapeutic touch as necessary).
Participants in Group A will receive a guided meditation prior to receiving the intra-articular injection.
Participants in Group B will receive an Elequil Aromatab and the same guided meditation delivered to Group A prior to receiving the intra-articular injection.
Outcomes
Primary Outcome Measures
Change in Short-Version Spielberger State-Trait Anxiety Inventory (SSTAI) Score
The Short-Version SSTAI is a 10-item self-assessment of anxiety, with 5 items assessing states of anxiety and 5 items assessing traits of anxiety. Each item is scored on a Likert scale ranging from 1 to 4, where (1 = not at all) and (4 = very much so). The total score is the sum of responses and ranges from 10-40; lower scores indicate lower levels of anxiety. A decrease in scores indicates anxiety decreased during the observational period.
Change in Pain Score
On a scale of 0 to 10 (0 = no pain, 10 = the worst pain imaginable), participants rank their pain prior to the injection and after the injection. The total score ranges from 0-10, with higher scores indicating greater pain. A decrease in score indicates pain decreased during the observational period.
Change in Blood Pressure
Participants will have their blood pressure (systolic/diastolic - mmHg) taken before and after the injection.
Change in Heart Rate
Participants will have their heart rate (beats per minute) measured before and after the injection.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05832983
Brief Title
Aromatherapy and Anxiety Study
Official Title
The Effect of Aromatherapy on Situational Anxiety in Adults Receiving Intra-Articular Injections in the Ambulatory Clinic Setting
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 4, 2023 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
While intra-articular injections can alleviate pain in orthopedic patients, this can be an anxiety-provoking experience. Adult patients scheduled to receive an injection at the study location will be randomly assigned to one of three groups. The control group (C) will receive the current standard of nursing care. The first experimental group (A) will receive a guided meditation prior to receiving the injection. The second experimental group (B) will receive an Elequil Aromatab and the same guided meditation prior to receiving the injection.
Detailed Description
The objective of the study is to measure the difference in anxiety levels of adult orthopedic patients in need of intra-articular injections who receive a guided meditation only prior to their injection, compared to those who receive a guided meditation and an aromatherapy Elequil Aromatab prior to injection, as well as compared with those who receive the usual standard of care
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Related to Pain Related to an Intraarticular Injection, Pain Related to an Intraarticular Injection
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in the control arm will receive the current standard of nursing care for treating anxiety prior to receiving the intra-articular injection (emotional support, distraction, and/or therapeutic touch as necessary).
Arm Title
Experimental Group A
Arm Type
Experimental
Arm Description
Participants in Group A will receive a guided meditation prior to receiving the intra-articular injection.
Arm Title
Experimental Group B
Arm Type
Experimental
Arm Description
Participants in Group B will receive an Elequil Aromatab and the same guided meditation delivered to Group A prior to receiving the intra-articular injection.
Intervention Type
Behavioral
Intervention Name(s)
Guided Meditation
Intervention Description
In private exam room, the study registered nurse (RN) will read a prepared two minute guided meditation to patient.
Intervention Type
Other
Intervention Name(s)
Aromatherapy
Other Intervention Name(s)
Elequil Aromatab
Intervention Description
In private exam room, study RN will first affix an Elequil Aromatab to patient's clothing on either their upper arm or chest (whichever the patient prefers and/or as clothing allows).
Primary Outcome Measure Information:
Title
Change in Short-Version Spielberger State-Trait Anxiety Inventory (SSTAI) Score
Description
The Short-Version SSTAI is a 10-item self-assessment of anxiety, with 5 items assessing states of anxiety and 5 items assessing traits of anxiety. Each item is scored on a Likert scale ranging from 1 to 4, where (1 = not at all) and (4 = very much so). The total score is the sum of responses and ranges from 10-40; lower scores indicate lower levels of anxiety. A decrease in scores indicates anxiety decreased during the observational period.
Time Frame
10-15 minutes prior to injection, 5 minutes post-injection (Day 1)
Title
Change in Pain Score
Description
On a scale of 0 to 10 (0 = no pain, 10 = the worst pain imaginable), participants rank their pain prior to the injection and after the injection. The total score ranges from 0-10, with higher scores indicating greater pain. A decrease in score indicates pain decreased during the observational period.
Time Frame
10-15 minutes prior to injection, 5 minutes post-injection (Day 1)
Title
Change in Blood Pressure
Description
Participants will have their blood pressure (systolic/diastolic - mmHg) taken before and after the injection.
Time Frame
10-15 minutes prior to injection, 5 minutes post-injection (Day 1)
Title
Change in Heart Rate
Description
Participants will have their heart rate (beats per minute) measured before and after the injection.
Time Frame
10-15 minutes prior to injection, 5 minutes post-injection (Day 1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patient has an in-office appointment at the NYU Langone Ambulatory Care-23rd Street location with either the Ortho A & B (primarily those patients who may be seeking knee or hip replacement surgery), Hand, or Primary Sport clinics.
Patient has an order for an intra-articular injection (as determined by clinic MD) and has consented to receiving that treatment.
Patient is English speaking.
Exclusion Criteria:
Patient has a cognitive or physical disability that would interfere with their ability to complete the study's pre and post assessments with RN.
Patient is found on the pre-injection assessment form to have an intolerance or allergy to lavender, sandalwood, or strong scents in general.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meredith D'Anna
Phone
646-754-1420
Email
Meredith.DAnna@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Kathleen Zavotsky
Phone
212-263-2055
Email
Kathleen.Zavotsky@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meredith D'Anna
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data to be used for only this study.
Learn more about this trial
Aromatherapy and Anxiety Study
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