Lavender Aromatherapy for Procedural Anxiety and Pain

Overseen By Amira Quevedo, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Florida

Disqualifiers: Pelvic infection, Cancer, Hypertension, others

Prior Safety Data This treatment has passed at least one previous human trial

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 lavender aromatherapy can reduce anxiety and pain for women undergoing an office hysteroscopy, a procedure to examine the inside of the uterus. Researchers aim to determine if inhaling lavender oil helps patients feel calmer and less stressed compared to a placebo (a non-active substance). Women scheduled for a hysteroscopy who experience some anxiety might be suitable candidates for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

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.

Is there any evidence suggesting that lavender aromatherapy is likely to be safe for humans?

Research has shown that lavender aromatherapy is generally safe for reducing anxiety. One study found that inhaling lavender essential oil safely lowered anxiety levels. Another study demonstrated that lavender aromatherapy significantly reduced anxiety compared to a group that did not use it. These findings suggest that lavender aromatherapy is well-tolerated, with no major safety concerns reported.

While these studies focus on anxiety, they indicate that lavender aromatherapy might be a safe option for this trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about lavender aromatherapy for procedural anxiety and pain because it offers a natural alternative to traditional treatments like anti-anxiety medications and analgesics, which often come with side effects. Unlike these medications, lavender aromatherapy uses the calming properties of lavender essential oil, known for reducing stress and promoting relaxation without pharmacological intervention. This method is simple and non-invasive, involving just a few drops of lavender oil on a paper towel, making it an appealing option for those seeking a gentle approach to managing anxiety and pain during medical procedures.

What evidence suggests that lavender aromatherapy might be an effective treatment for procedural anxiety and pain?

Research has shown that lavender aromatherapy, which participants in this trial may receive, can help reduce anxiety and pain. For example, studies have found that inhaling lavender essential oil effectively lowers anxiety and pain levels after surgeries like C-sections and breast biopsies. Another study found that lavender oil eased anxiety and pain when used before certain medical procedures. Overall, the evidence suggests lavender aromatherapy may calm nerves and lessen discomfort during stressful medical procedures. ^{1 4 6 7 8}

Who Is on the Research Team?

Tiffani-Amber Miller, MD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for women over 18 who are scheduled for an office hysteroscopy, can consent, read and write in English, and have some anxiety about the procedure. It's not for those allergic to lavender or with conditions that make hysteroscopy risky like severe infections or certain cancers.

Inclusion Criteria

Anxiety score > 0 on a numerical scale at baseline

Able to give informed consent

Able to read and write in English

Exclusion Criteria

I do not have conditions like severe infections or high blood pressure that make certain pelvic exams unsafe.

Allergy to lavender oil, or any of its components

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo office hysteroscopy with either lavender aromatherapy or placebo to assess anxiety and pain levels

1 day

1 visit (in-person)

Follow-up

Participants are monitored for satisfaction, pain, and anxiety levels immediately after the procedure

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Lavender Aromatherapy

Trial Overview

The study tests if lavender aromatherapy (using Lavandula angustifolia oil by Aura Cacia) can reduce stress and pain during a hysteroscopy compared to a placebo (distilled water). Participants' anxiety levels will be measured using questionnaires.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 1 Intervention

Prior to starting the procedure, the clinic nurse will prepare the aromatherapy Lavender essential oil on a paper towel by applying two drops of each solution on a paper towel. The patients will hold the paper towel over their nose and then they will be asked to take two deep breaths. Before the physician comes in, the nurse will ask the participant to take a deep breath while holding the towel 3 inches from her face and will instruct the participant to continue to take normal breaths subsequently

Group II: Placebo Placebo Group 1 Intervention

Prior to starting the procedure, the clinic nurse will prepare the distilled water on a paper towel by applying two drops of each solution on a paper towel. The patients will hold the paper towel over their nose and then they will be asked to take two deep breaths. Before the physician comes in, the nurse will ask the participant to take a deep breath while holding the towel 3 inches from her face and will instruct the participant to continue to take normal breaths subsequently

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

In a randomized controlled study involving 90 adult patients undergoing endoscopic retrograde cholangiopancreatography (ERCP), lavender oil intervention significantly reduced patients' pulse rate, blood pressure, pain, and anxiety levels.

The use of lavender oil also led to an increase in oxygen saturation levels, indicating its potential as a safe and effective complementary treatment to improve patient comfort before medical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of lavender oil intervention before endoscopic retrograde cholangiopancreatography on patients' vital signs, pain and anxiety: A randomized controlled study. Citlik Saritas, S., Buyukbayram, Z., Kaplan Serin, E., 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]

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 using lavender or sweet orange essential oils significantly reduced dental anxiety in children aged 8-12 during local anesthetic procedures, as shown by lower anxiety scores compared to a control group.

Sweet orange essential oil specifically helped to decrease self-reported pain levels during the procedure, indicating its potential as an effective complementary approach in pediatric dentistry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Aromatherapy on Dental Anxiety and Pain in Children Undergoing Local Anesthetic Administrations: A Randomized Clinical Trial. Nirmala, K., Kamatham, R.[2021]

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 feasibility study involving 36 patients undergoing awake craniotomies, 77.5% completed the study, indicating that lavender aromatherapy can be integrated into the operating room setting.

While lavender inhalation did not show statistically significant reductions in anxiety or pain, there was a trend towards lower pain scores, and most patients reported satisfaction with their pain management, suggesting potential benefits worth exploring in further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Feasibility Study of Lavender Aromatherapy in an Awake Craniotomy Environment. Cathey, K., Gunyon, N., Chung, N., et al.[2022]

A review of 20 randomized controlled trials found that lavender essential oil significantly improves sleep quality in adults, with 14 studies showing positive effects.

The improvement in sleep quality was measured using both subjective and objective indicators, suggesting that lavender oil can be beneficial even before the onset of insomnia or other sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Lavender on Sleep Quality in Individuals Without Insomnia: A Systematic Review. Chen, TY., Hiyama, A., Muramatsu, M., et al.[2023]

In a study of 54 subjects undergoing lumbar epidural steroid injections, those exposed to lavender showed the highest reduction in anxiety scores compared to control groups using almond oil and water, suggesting lavender may help alleviate anxiety during procedures.

The lavender group also reported lower pain levels during the procedure, indicating potential benefits for pain management, although these findings did not reach statistical significance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Lavender on Pain and Anxiety Levels Associated With Spine Procedures. Grabnar, M., Roach, MJ., Abd-Elsayed, A., et al.[2022]

In a study of 50 patients undergoing breast biopsy surgery, lavender oil aromatherapy did not significantly reduce pain scores compared to a control group, indicating limited analgesic efficacy.

However, patients who received lavender oil reported higher satisfaction with their pain control, suggesting that while it may not reduce pain intensity, it could enhance the overall experience of pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of aromatherapy in treating postoperative pain: pilot study. Kim, JT., Wajda, M., Cuff, G., et al.[2021]

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]

In a study involving 44 surgical patients, lavender aromatherapy was associated with a significant decrease in preoperative anxiety, particularly among female participants, with 48% reporting reduced anxiety after the intervention.

While the results suggest that lavender aromatherapy can be a beneficial complementary treatment for preoperative anxiety, the study lacked a control group and randomization, making it difficult to establish a direct cause-and-effect relationship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lavender Aromatherapy as a Nurse-Driven Intervention for Preoperative Anxiety. Koehler, T.[2022]

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