CompletedNot Applicable

Aromatherapy and Anxiety Study

United States20 participantsStarted 2023-07-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Short-Version Spielberger State-Trait Anxiety Inventory (SSTAI) Score

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

Change in Pain Score

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

Change in Blood Pressure

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

Change in Heart Rate

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

Trial details

NCT IDNCT05832983

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-21

View on ClinicalTrials.gov More Anxiety Related to Pain Related to an Intraarticular Injection trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Short-Version Spielberger State-Trait Anxiety Inventory (SSTAI) Score

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

Change in Pain Score

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

Change in Blood Pressure

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

Change in Heart Rate

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