Aromatherapy and Anxiety Study

Not Applicable

Completed

• Conditions: Anxiety Related to Pain Related to an Intraarticular Injection; Pain Related to an Intraarticular Injection
• Interventions: Behavioral: Guided Meditation; Other: Aromatherapy

• Registration Number: NCT05832983
• Lead Sponsor: NYU Langone Health

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

Study Timeline

• Study First Submitted: 2023-04-17
• Study First Submitted QC: 2023-04-17
• Study First Posted: 2023-04-27
• Study Start: 2023-07-04
• Primary Completion: 2024-02-21
• Study Completion: 2024-02-21
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group B	Aromatherapy	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.
Experimental Group A	Guided Meditation	Participants in Group A will receive a guided meditation prior to receiving the intra-articular injection.
Experimental Group B	Guided Meditation	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.

Primary Outcome Measures

Name	Time	Method
Change in Pain Score	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.
Change in Short-Version Spielberger State-Trait Anxiety Inventory (SSTAI) Score	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.
Change in Blood Pressure	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.
Change in Heart Rate	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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States