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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Guided Meditation + Aromatherapy for Anxiety?

Research shows that aromatherapy massage can help reduce anxiety and depression in cancer patients, as seen in studies where patients reported lower anxiety scores after receiving aromatherapy sessions. This suggests that aromatherapy, a component of the treatment, may be effective in managing anxiety. ^{1 2 3 4 5}

Is guided meditation with aromatherapy safe for humans?

Aromatherapy and guided meditation are generally considered safe for humans when used properly. Essential oils, like lavender, have been shown to have calming effects and are usually safe at low concentrations, but caution is advised during pregnancy and for those with sensitivities. ^{6 7 8 9 10}

How does the Guided Meditation + Aromatherapy treatment for anxiety differ from other treatments?

This treatment combines guided meditation with aromatherapy, using essential oils like lavender, which is unique because it targets anxiety through both mental relaxation and the calming effects of scents. Unlike standard drug treatments, this approach is non-invasive and focuses on natural methods to reduce anxiety. ^{3 6 11 12 13}

Research Team

Jennifer Withall, PhD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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

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

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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 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 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]

References

1. United States 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Anxiolytic effect of aromatherapy massage in patients with breast cancer. [2020]

3. England pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Topical Aromatherapy: Increasing Staff Knowledge and Alleviating Anxiety in Patients With Cancer. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Development of an aromatherapy service at a Cancer Centre. [2017]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Aromatherapy with two essential oils from Satureja genre and mindfulness meditation to reduce anxiety in humans. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Essential oils and 'aromatherapy': their modern role in healing. [2019]

8. United States 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Essential oil of lavender in anxiety disorders: Ready for prime time? [2020]

10. England pubmed.ncbi.nlm.nih.gov

Possible health and safety problems in the use of novel plant essential oils and extracts in aromatherapy. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Essential oils and anxiolytic aromatherapy. [2009]

12. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of aromatherapy with inhaled lavender essential oil and breathing exercises on ECT-related anxiety in depressed patients. [2022]

13. Ireland pubmed.ncbi.nlm.nih.gov

Aromatherapy for health care: an overview of systematic reviews. [2022]