What is the mechanism of action of this treatment?

Guided meditation works by promoting relaxation and reducing stress through focused attention and mindfulness, which can decrease sympathetic nervous system activity and lower cortisol levels. Elequil Aromatab, an aromatherapy intervention, uses olfactory stimulation to influence the limbic system, which is involved in emotion regulation and stress response. These mechanisms are crucial for anxiety patients as they provide non-pharmacological options to manage anxiety symptoms, potentially reducing the need for medication and its associated side effects. By leveraging the body's natural relaxation responses, these treatments can offer immediate and accessible relief from anxiety.

What side effects are associated with this type of intervention?

Relaxation techniques like guided meditation generally have minimal side effects but can occasionally cause relaxation-induced panic in some individuals. Olfactory stimulation, such as aromatherapy, is typically well-tolerated, though some people may experience mild allergic reactions or headaches. Both methods are considered safe and non-invasive, making them suitable for many patients.

What prior FDA approvals exist?

FDA-approved treatments for anxiety primarily include pharmacologic options such as selective serotonin reuptake inhibitors (SSRIs) like sertraline and fluoxetine, serotonin-norepinephrine reuptake inhibitors (SNRIs) like venlafaxine, and benzodiazepines like alprazolam and lorazepam. Non-pharmacologic treatments such as guided meditation and aromatherapy, including the use of Elequil Aromatab, are not typically FDA-approved as primary treatments but are often used as complementary therapies to help manage anxiety symptoms.

What other types of research exist?

Promising novel alternatives for anxiety treatment include Transcutaneous Electrical Acupoint Stimulation (TEAS), which has been shown to reduce stress responses and improve the quality of anesthesia recovery, and acupuncture, which has demonstrated anxiolytic effects by modulating dopaminergic systems. Both methods offer non-pharmacologic options that can be considered for anxiety management.

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Guided Meditation + Aromatherapy for Anxiety

N/A

Recruiting

Led By Jennifer Withall, PhD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10-15 minutes prior to injection, 5 minutes post-injection (day 1)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether guided meditation and aromatherapy can reduce anxiety in adult orthopedic patients who need joint injections. Participants will either listen to a calming voice, use a device that releases soothing smells, or receive standard care. The goal is to see which method helps patients feel less anxious.

Who is the study for?

This trial is for adult English-speaking patients at NYU Langone's specific clinics, who are scheduled to receive an intra-articular injection and have consented to that treatment. It aims to help those experiencing anxiety or pain associated with these injections.

What is being tested?

The study examines if guided meditation alone (Group A) or combined with aromatherapy using an Elequil Aromatab (Group B) before the injection can reduce anxiety compared to standard nursing care (Control Group C). Participants are randomly placed into one of these three groups.

What are the potential side effects?

Since this trial involves non-invasive interventions like guided meditation and aromatherapy, side effects may be minimal but could include potential allergic reactions to the aromatherapy product.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10-15 minutes prior to injection, 5 minutes post-injection (day 1)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10-15 minutes prior to injection, 5 minutes post-injection (day 1)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10-15 minutes prior to injection, 5 minutes post-injection (day 1) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Blood Pressure

Change in Heart Rate

Change in Pain Score

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Experimental Group BExperimental Treatment2 Interventions

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.

Group II: Experimental Group AExperimental Treatment1 Intervention

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

Group III: ControlActive Control1 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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Guided Meditation

2021

N/A

~400

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Guided meditation works by promoting relaxation and reducing stress through focused attention and mindfulness, which can decrease sympathetic nervous system activity and lower cortisol levels. Elequil Aromatab, an aromatherapy intervention, uses olfactory stimulation to influence the limbic system, which is involved in emotion regulation and stress response. These mechanisms are crucial for anxiety patients as they provide non-pharmacological options to manage anxiety symptoms, potentially reducing the need for medication and its associated side effects. By leveraging the body's natural relaxation responses, these treatments can offer immediate and accessible relief from anxiety.

The effects of inhalation aromatherapy on anxiety in patients with myocardial infarction: a randomized clinical trial.