Lavender Aromatherapy for Anxiety

(RELAX Trial)

Overseen By Megan Tarr, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Pregnancy, Lavender allergy, UTI, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether lavender aromatherapy (lavender essential oil) and other calming elements, such as music and dim lighting, can reduce anxiety and pain during bladder treatment for women with urinary urgency issues. The researchers aim to determine if these relaxing measures can make the procedure less stressful and more satisfying. Women who need bladder injections for overactive bladder and often experience anxiety might be suitable participants. The study also examines whether the calming environment benefits the medical staff's well-being while working.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance comfort and satisfaction during medical procedures.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that lavender aromatherapy is safe for anxiety reduction?

Research has shown that lavender aromatherapy is generally safe. The FDA considers lavender essential oil safe, reassuring those concerned about trying it. Studies have found that lavender effectively alleviates anxiety, with only mild and temporary side effects reported. People have safely inhaled lavender oil for up to 12 weeks. Thus, trying lavender aromatherapy, even as part of a trial, is unlikely to cause serious problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for anxiety because they explore the calming effects of lavender aromatherapy, which differs from traditional medications like benzodiazepines and SSRIs. Lavender aromatherapy is unique because it uses natural plant-derived scents, offering a non-invasive and soothing alternative to medication. This approach not only potentially reduces anxiety but also enhances the environment by pairing aromatherapy with calming music and dim lighting, creating a holistic relaxation experience. By potentially avoiding medication side effects, this method might appeal to those seeking natural and gentle anxiety relief options.

What evidence suggests that lavender aromatherapy could be effective for reducing anxiety during bladder chemodenervation?

Research has shown that lavender aromatherapy, one of the treatments under study in this trial, can help reduce anxiety. Studies have found that inhaling lavender essential oil can lower anxiety levels. Lavender affects the part of the brain that controls emotions, promoting calmness. It might even reduce the need for anxiety medications like benzodiazepines. Overall, lavender aromatherapy has consistently demonstrated a strong calming effect, which may help individuals feel more relaxed in stressful situations. Participants in this trial may experience lavender aromatherapy through various interventions, such as a lavender aromatherapy sticker or a relaxing environment with calming music and dim lighting. ^{6 7 8 9 10}

Who Is on the Research Team?

Megan Tarr, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for women with Urge urinary incontinence (UUI) who experience anxiety and pain during bladder chemodenervation procedures. Participants must be scheduled for the procedure at Atrium Health's clinic and willing to try a relaxing environment package or placebo before treatment.

Inclusion Criteria

I am not pregnant.

Baseline visual analog scale for anxiety ≥12mm

I am scheduled for a bladder procedure due to overactive bladder symptoms.

Exclusion Criteria

I do not have an active urinary tract infection.

Allergy to lavender oil

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Pre-procedure Assessment

Participants are randomized to either the relaxing environment package or the placebo group and complete baseline VAS for anxiety and pain.

1 day

1 visit (in-person)

Chemodenervation Procedure

Participants undergo intra-detrusor chemodenervation with either the relaxing environment package or typical office environment. Post-procedure VAS for anxiety, pain, and satisfaction are completed.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure.

up to 2 hours post-procedure

What Are the Treatments Tested in This Trial?

Interventions

• Lavender Aromatherapy

Trial Overview

The study tests if a 'Relaxing Environment Package'—lavender aromatherapy, calming music, dim lighting—lowers anxiety and pain compared to a standard office setting during bladder chemodenervation. It's a randomized control trial where participants are assigned by chance to either the relaxing setup or placebo group.

How Is the Trial Designed?

Group I: Procedure Team Intervention - relaxing environment Experimental Treatment 1 Intervention

lavender aromatherapy, calming music, and dim lighting - Members of the procedure team - participation in this research will involve a 3 question initial questionnaire survey to assess demographics and prior experience with aromatherapy and pre- and post-clinic survey on the days you participate in bladder Botox procedures.

Group II: Lavender aromatherapy sticker Experimental Treatment 1 Intervention

Lavender aromatherapy sticker on patient Calming music from Sirius station 68 (Spa) playing via overhead speakers Overhead lights off, two lanterns lit to provide dim lighting Avoid stirrup use

Group III: Control - no Intervention Active Control 1 Intervention

Non-aromatic (placebo) sticker on patient No music playing Overhead lights on Stirrups used

Group IV: Procedure Team Control - no Intervention Active Control 1 Intervention

Members of the procedure team - participation in this research will involve a 3 question initial questionnaire survey to assess demographics and prior experience with aromatherapy and pre- and post-clinic survey on the days you participate in bladder Botox procedures.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

Lavender essential oils, particularly from species like L. angustifolia and L. latifolia, have been traditionally used for various therapeutic purposes, including antibacterial and sedative effects, but scientific evidence supporting these claims is still inconclusive.

Current research indicates some support for the traditional uses of lavender oils, yet issues with study methodologies and oil identification have made it difficult to fully understand their therapeutic significance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biological activities of lavender essential oil. Cavanagh, HM., Wilkinson, JM.[2022]

In a study involving 17 cancer hospice patients, aromatherapy with 3% lavender oil showed a small positive effect on vital signs, pain, anxiety, depression, and overall sense of well-being after a 60-minute session.

Both lavender aromatherapy and humidified water treatments resulted in similar slight improvements, suggesting that the observed benefits may not be solely due to the lavender oil itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of aromatherapy with hospice patients to decrease pain, anxiety, and depression and to promote an increased sense of well-being. Louis, M., Kowalski, SD.[2017]

Inhalation of lavender oil significantly reduced blood pressure post-operatively in patients undergoing wisdom tooth removal, indicating its potential effectiveness in managing anxiety during surgical procedures.

A high percentage of patients (89.68%) reported satisfaction with the lavender oil experience, and 97.62% expressed a desire to use the same protocol again, suggesting that lavender oil is well-received and could be a beneficial addition to anxiety management strategies in dental surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of lavender oil inhalation on vital signs and anxiety: A randomized clinical trial. Karan, NB.[2020]

Lavender essential oil (1-5%) significantly reduced anxiety-like behavior in male Swiss mice, as shown by decreased marble burying and increased exploration in the elevated plus maze, indicating its potential anxiolytic effects.

The study suggests that the anxiolytic effects of lavender are mediated through the serotonin 5-HT1A receptor, as blocking this receptor with WAY100635 eliminated the anxiety-reducing effects of lavender, while GABAA receptor antagonism did not affect its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anxiolytic-like effect of lavender essential oil inhalation in mice: participation of serotonergic but not GABAA/benzodiazepine neurotransmission. Chioca, LR., Ferro, MM., Baretta, IP., et al.[2016]

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]

In a study of 97 participants, orally administered lavender capsules showed a trend towards reduced anxiety and improved heart rate variability (HRV) during neutral film clips, particularly at a 200 microl dose.

Lavender appeared to have mild anxiolytic effects in females during anxiety-provoking situations, but these effects were not observed in males, indicating that lavender's efficacy may vary by gender and anxiety levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of orally administered lavender essential oil on responses to anxiety-provoking film clips. Bradley, BF., Brown, SL., Chu, S., et al.[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 study involving 100 ambulatory surgery patients found that inhaling lavender aromatherapy significantly reduced preoperative anxiety compared to standard nursing care, with a statistically significant difference (p = 0.001).

The reduction in anxiety was modest, suggesting that while lavender aromatherapy can be beneficial, further research is needed to confirm its clinical effectiveness in managing preoperative anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Lavender Aromatherapy in Reducing Preoperative Anxiety in Ambulatory Surgery Patients Undergoing Procedures in General Otolaryngology. Wotman, M., Levinger, J., Leung, L., et al.[2022]

This study is a multicenter, double-masked, randomized, placebo-controlled trial aimed at evaluating the effectiveness of lavender essential oil in reducing the use of benzodiazepines among patients aged 20-59 with generalized anxiety disorder and panic disorder.

If successful, using lavender aroma could provide a safe and cost-effective alternative to benzodiazepines for managing anxiety, potentially reducing the associated risks of these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of lavender aroma for anxiety disorder: a study protocol for a multicenter, double-masked, randomized, placebo-controlled clinical trial. Amitani, H., Nishi, R., Sagiyama, K., et al.[2023]

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]

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