Aromatherapy and Anxiety Study

July 12, 2023 updated by: NYU Langone Health

The Effect of Aromatherapy on Situational Anxiety in Adults Receiving Intra-Articular Injections in the Ambulatory Clinic Setting

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10010
        • Recruiting
        • NYU Langone Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
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).
Experimental: Experimental Group A
Participants in Group A will receive a guided meditation prior to receiving the intra-articular injection.
Behavioral: Guided Meditation
In private exam room, the study registered nurse (RN) will read a prepared two minute guided meditation to patient.
Experimental: Experimental Group B
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.
Behavioral: Guided Meditation
In private exam room, the study registered nurse (RN) will read a prepared two minute guided meditation to patient.
Other: Aromatherapy
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).
Other Names:
  • Elequil Aromatab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Short-Version Spielberger State-Trait Anxiety Inventory (SSTAI) Score
Time Frame: 10-15 minutes prior to injection, 5 minutes post-injection (Day 1)
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.
10-15 minutes prior to injection, 5 minutes post-injection (Day 1)
Change in Pain Score
Time Frame: 10-15 minutes prior to injection, 5 minutes post-injection (Day 1)
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.
10-15 minutes prior to injection, 5 minutes post-injection (Day 1)
Change in Blood Pressure
Time Frame: 10-15 minutes prior to injection, 5 minutes post-injection (Day 1)
Participants will have their blood pressure (systolic/diastolic - mmHg) taken before and after the injection.
10-15 minutes prior to injection, 5 minutes post-injection (Day 1)
Change in Heart Rate
Time Frame: 10-15 minutes prior to injection, 5 minutes post-injection (Day 1)
Participants will have their heart rate (beats per minute) measured before and after the injection.
10-15 minutes prior to injection, 5 minutes post-injection (Day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Meredith D'Anna, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

April 17, 2023

First Submitted That Met QC Criteria

April 17, 2023

First Posted (Actual)

April 27, 2023

Study Record Updates

Last Update Posted (Actual)

July 14, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-00170

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data to be used for only this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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