Guided Meditation + Aromatherapy for Anxiety

Overseen By Jennifer Withall, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Cognitive disability, Physical disability, Scent allergy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether guided meditation and aromatherapy (essential oil therapy) can reduce anxiety in patients about to receive joint injections. The study includes three groups: one receives standard care, another receives guided meditation, and the last receives both guided meditation and aromatherapy. It is designed for English-speaking patients at specific NYU Langone clinics who are scheduled for joint injections and are open to trying meditation and aromatherapy. As an unphased trial, this study provides a unique opportunity for patients to explore innovative anxiety-reduction techniques in a supportive environment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that guided meditation can help reduce stress and anxiety. However, some studies found that it might increase anxiety for certain individuals and, in rare cases, lead to more serious issues like psychosis, a mental disorder where someone loses touch with reality. Most people handle meditation well, but awareness of these rare possibilities is important.

For aromatherapy, results are mixed. Some research suggests that essential oils can help reduce anxiety, while other studies find little improvement. Generally, aromatherapy is considered safe, with few reports of side effects.

Both guided meditation and aromatherapy are usually well-tolerated, but considering these findings is important when choosing what feels right. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using guided meditation and aromatherapy for anxiety because these treatments offer a natural and non-invasive alternative to traditional care. Unlike typical anxiety treatments that often involve medication, guided meditation helps calm the mind by encouraging focus and relaxation. Aromatherapy, using the Elequil Aromatab, introduces soothing scents that can enhance mood and reduce stress. The combination of these techniques could provide a holistic approach to anxiety management, appealing to those seeking alternatives to pharmaceuticals.

What evidence suggests that this trial's treatments could be effective for anxiety?

Research has shown that guided meditation, which participants in Experimental Group A of this trial will receive, can help reduce anxiety. Studies indicate it can be somewhat effective, with a noticeable impact on improving anxiety and mood. One study found that meditating for just 10 to 20 minutes lowered anxiety levels.

In Experimental Group B, participants will receive both guided meditation and aromatherapy. The evidence for combining guided meditation with aromatherapy is still developing. Some research suggests this combination might reduce anxiety symptoms more effectively than meditation alone. Aromatherapy has shown promise in reducing stress and anxiety when used with other therapies like music. While more research is needed, early signs are encouraging for using these methods to ease anxiety in stressful situations. ^{6 7 8 9 10}

Who Is on the Research Team?

Jennifer Withall, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have an appointment at NYU Langone's Ortho, Hand, or Primary Sport clinics.

I am approved and have agreed to get a joint injection.

Patient is English speaking

Exclusion Criteria

I have a condition that makes it hard for me to complete study tasks.

Patient is found on the pre-injection assessment form to have an intolerance or allergy to lavender, sandalwood, or strong scents in general

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive either standard care, guided meditation, or guided meditation with aromatherapy prior to intra-articular injection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in anxiety, pain, blood pressure, and heart rate after treatment

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Aromatherapy
• Guided Meditation

Trial Overview 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.

How Is the Trial Designed?

Group I: Experimental Group B Experimental Treatment 2 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 A Experimental Treatment 1 Intervention

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

Group III: Control Active Control 1 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).

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

A study involving 108 participants found that combining aromatherapy with essential oils and mindfulness meditation significantly reduced anxiety levels, with reductions ranging from 20% to 47%.

The results indicated a large effect size for anxiety reduction, particularly in groups using both aromatherapy and mindfulness together, suggesting that these methods can be effective alternative treatments for anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aromatherapy with two essential oils from Satureja genre and mindfulness meditation to reduce anxiety in humans. Soto-Vásquez, MR., Alvarado-García, PA.[2020]

In a randomized clinical trial with 110 female university employees, lavender aromatherapy massage significantly reduced work-related stress and personal burnout compared to a control group, which only showed a decrease in type A personality traits after receiving a regular massage.

Both lavender aromatherapy massage and regular massage improved heart rate variability (HRV) parameters, indicating potential benefits for stress management, but the lavender group showed more pronounced effects in certain HRV measures, suggesting it may be a more effective intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Immediate Effects of Lavender Aromatherapy Massage versus Massage in Work Stress, Burnout, and HRV Parameters: A Randomized Controlled Trial. Wu, CY., Lee, HF., Chang, CW., et al.[2022]

Lavender essential oil has shown clinical efficacy in reducing anxiety symptoms, making it a promising complementary therapy for anxiety disorders, which often have limited treatment options.

The anxiolytic effects of lavender oil are attributed to its key components, linalool and linalyl acetate, which may work by inhibiting calcium channels and modulating serotonin receptor activity, contributing to its safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Essential oil of lavender in anxiety disorders: Ready for prime time? Malcolm, BJ., Tallian, K.[2020]

Aromatherapy, while popular, lacks strong scientific support and is often combined with massage and counseling, which may enhance its perceived benefits.

Most commonly used essential oils in aromatherapy are generally safe at low concentrations, but their safety during pregnancy and for infants is not well established, and there is a growing concern about sensitization and the introduction of potentially toxic novel plant products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Possible health and safety problems in the use of novel plant essential oils and extracts in aromatherapy. Lis-Balchin, M.[2019]

A systematic review of 10 studies on aromatherapy found that while it is used for various conditions like hypertension, depression, and anxiety, the overall evidence supporting its effectiveness is not convincing.

Most systematic reviews evaluated were of poor methodological quality, indicating that more rigorous research is needed to determine if aromatherapy can be considered an effective therapeutic intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aromatherapy for health care: an overview of systematic reviews. Lee, MS., Choi, J., Posadzki, P., et al.[2022]

Aromatherapy massage significantly reduced anxiety levels in breast cancer patients, as evidenced by improvements in the State-Trait Anxiety Inventory and Hospital Anxiety and Depression Scale tests during and after treatment.

The study also indicated that aromatherapy massage may enhance the immunologic state of patients, suggesting potential benefits beyond psychological effects, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anxiolytic effect of aromatherapy massage in patients with breast cancer. Imanishi, J., Kuriyama, H., Shigemori, I., et al.[2020]

In a study involving 288 cancer patients, aromatherapy massage showed a significant short-term benefit in reducing anxiety and depression at 6 weeks post-treatment, but not at 10 weeks, indicating its effects may diminish over time.

While patients reported greater self-improvement in anxiety after receiving aromatherapy massage, the long-term efficacy compared to usual supportive care was not significant, suggesting that while it may help temporarily, it may not be a lasting solution for managing anxiety and depression in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of aromatherapy massage in the management of anxiety and depression in patients with cancer: a multicenter randomized controlled trial. Wilkinson, SM., Love, SB., Westcombe, AM., et al.[2022]

The quality improvement project aimed to enhance staff understanding of topical aromatherapy as a method to alleviate anxiety in cancer patients.

By implementing this project, the researchers sought to assess how effective topical aromatherapy could be in reducing anxiety levels among individuals undergoing cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical Aromatherapy: Increasing Staff Knowledge and Alleviating Anxiety in Patients With Cancer. Kruger, MB., Wittren, SP.[2023]

Aromatherapy with inhaled lavender essential oil and breathing exercises significantly reduced anxiety in 90 depressed patients undergoing electroconvulsive therapy (ECT), as shown by a randomized controlled trial.

Both interventions were effective in lowering anxiety scores compared to routine care, suggesting they are simple and practical options for managing ECT-related anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of aromatherapy with inhaled lavender essential oil and breathing exercises on ECT-related anxiety in depressed patients. Moghadam, ZE., Delmoradi, F., Aemmi, SZ., et al.[2022]

A pilot study involving 28 postpartum women showed that aromatherapy significantly improved anxiety and depression scores compared to a control group, indicating its potential as a complementary therapy.

The study reported no adverse effects from the aromatherapy sessions, suggesting it is a safe option for postpartum women experiencing anxiety and depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of clinical aromatherapy for anxiety and depression in the high risk postpartum woman - a pilot study. Conrad, P., Adams, C.[2022]

Aromatherapy, which combines massage and pleasant scents, is increasingly recognized for its ability to help relieve stress-related disorders, making it a valuable tool in healthcare settings like hospitals and hospices.

While the exact mechanisms of how essential oils work in the body are not fully understood, they have shown potential antimicrobial and antioxidant properties, and can influence brain activity and behavior, suggesting that their effects may be mediated through the olfactory system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Essential oils and 'aromatherapy': their modern role in healing. Lis-Balchin, M.[2019]

Essential oils like lavender, rose, and bergamot are commonly used in aromatherapy to help relieve anxiety, stress, and depression, showcasing their potential as natural anxiolytic agents.

The review highlights the chemical components and central nervous system effects of these oils, suggesting that they may have therapeutic benefits in managing anxiety-related conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Essential oils and anxiolytic aromatherapy. Setzer, WN.[2009]

Aromatherapy massage significantly reduced anxiety and depression in cancer patients, with HADS scores improving from 8.9 to 6.2 for anxiety and from 6.1 to 4.0 for depression after six sessions, based on a study of 58 patients.

Over 50% of patients reported significant improvements in common symptoms, indicating that aromatherapy can play a beneficial role in managing psychological distress during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an aromatherapy service at a Cancer Centre. Kite, SM., Maher, EJ., Anderson, K., et al.[2017]

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