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

113 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Lavender Aromatherapy for anxiety?

Research shows that lavender aromatherapy can help reduce anxiety in various situations, such as before surgery and during treatments like electroconvulsive therapy (ECT) for depression. It is considered a simple and low-risk method to manage anxiety. ^{1 2 3 4 5}

Is lavender aromatherapy safe for humans?

Lavender essential oil has been used for centuries and is generally considered safe for humans, with studies supporting its use for anxiety and other conditions. However, the scientific data is still inconclusive, and more research is needed to fully understand its safety profile. ^{5 6 7 8 9}

How does lavender aromatherapy differ from other anxiety treatments?

Lavender aromatherapy is unique because it uses the inhalation of essential oils, specifically lavender, which contains compounds like linalool and linalyl acetate that may help reduce anxiety by affecting certain brain receptors and increasing relaxation. Unlike many traditional anxiety medications, it is a non-drug, natural approach with a low risk of dependence or withdrawal. ^{2 5 6 9 10}

What is the purpose of this trial?

Chemodenervation of the bladder with onabotulinum toxin A is an effective treatment option for patients with refractory urgency urinary incontinence (UUI). It is often performed as an office-based procedure under local anesthesia. Alternatively, it can be performed in the operating room under general anesthesia. The ability to receive intra-detrusor chemodenervation in the office allows patients to avoid the risks associated with general anesthesia and is significantly more cost effective. The procedure, however, is painful and can be anxiety provoking for patients; especially given that patients typically return every six to nine months for repeat injections. Relaxation and distraction techniques are one way to ease patients' anxiety before an office-based procedure. While we do not know exactly how anxiety provoking office bladder chemodenervation is for patients, we do know that anxiety disorders are highly prevalent in women with overactive bladder as a population. The purpose of this study is to investigate whether women with Urge urinary incontinence (UUI) who receive office intra-detrusor chemodenervation injections performed in a relaxing environment of lavender aromatherapy, calming music, dim lighting, and modest positioning (Relaxing Environment Package) will have decreased anxiety and pain as well as increased post-procedure satisfaction compared to patients who receive chemodenervation in a typical office environment. Also investigate whether exposure to the relaxing environment impacts the well-being of staff involved in these procedures. This study design is a randomized control trial. Women scheduled for office intra-detrusor chemodenervation at Atrium Health women's Care Urogynecology \& Pelvic Surgery - Mercy clinic will be invited to participate. Participants will be randomized to the relaxing environment package or the placebo group after informed consent is obtained and immediately before undergoing intra-detrusor chemodenervation. The participants will complete the pre-procedure visual analog scale (VAS) for anxiety and a VAS for pain at baseline.

Research Team

Megan Tarr, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2017]

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

The Efficacy of Lavender Aromatherapy in Reducing Preoperative Anxiety in Ambulatory Surgery Patients Undergoing Procedures in General Otolaryngology. [2022]

3. England 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. [2023]

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

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

5. 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]

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

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

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

Biological activities of lavender essential oil. [2022]

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

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

9. England pubmed.ncbi.nlm.nih.gov

Effects of orally administered lavender essential oil on responses to anxiety-provoking film clips. [2009]

10. Ireland pubmed.ncbi.nlm.nih.gov

Anxiolytic-like effect of lavender essential oil inhalation in mice: participation of serotonergic but not GABAA/benzodiazepine neurotransmission. [2016]