Aromatherapy and Anxiety Study

NCT05832983 | Completed

• 1 other identifier: 23-00170
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Related to Pain Related to an Intraarticular Injection; Pain Related to an Intraarticular Injection

Outcome Measures

Primary Outcomes (4)

• 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.

  10-15 minutes prior to injection, 5 minutes post-injection (Day 1)

• 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.

  10-15 minutes prior to injection, 5 minutes post-injection (Day 1)

• Change in Blood Pressure

  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

  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)

Study Arms (3)

Control

NO INTERVENTION

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 Group A

EXPERIMENTAL

Participants in Group A will receive a guided meditation prior to receiving the intra-articular injection.

Behavioral: Guided Meditation

Experimental Group B

EXPERIMENTAL

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; Other: Aromatherapy

Interventions

Guided Meditation BEHAVIORAL

In private exam room, the study registered nurse (RN) will read a prepared two minute guided meditation to patient.

Experimental Group A; Experimental Group B

Aromatherapy OTHER

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).

Also known as: Elequil Aromatab

Experimental Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10010, United States

Location

MeSH Terms

Interventions

Aromatherapy

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jennifer Withall, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: April 27, 2023
• Study Start: July 4, 2023
• Primary Completion: February 21, 2024
• Study Completion: February 21, 2024
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)