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

22 Participants Needed

Trial Summary

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.

What data supports the effectiveness of lavender aromatherapy for reducing anxiety and pain?

Research shows that lavender aromatherapy can help reduce anxiety in patients before surgery and improve satisfaction with pain control after surgery. In hospice patients, it also showed small improvements in pain, anxiety, and overall well-being. ^{1 2 3 4 5}

Is lavender aromatherapy safe for humans?

Lavender aromatherapy is generally considered safe for humans, with studies showing it can be used without significant side effects for anxiety, pain, and sleep quality. ^{1 2 4 6 7}

How does lavender aromatherapy differ from other treatments for procedural anxiety and pain?

Lavender aromatherapy is unique because it uses the natural scent of lavender oil to help reduce anxiety and pain, offering a simple, low-risk, and cost-effective alternative to traditional medications like sedatives or painkillers, which can have more side effects. ^{2 8 9 10 11}

What is the purpose of this trial?

Office hysteroscopy is an invaluable practice to treat a myriad of gynecological processes. However, a limiting factor is the perceived pain and anxiety. In a randomized pilot study, treatment with lavender aromatherapy will significantly decrease the stress/anxiety levels associated with office hysteroscopy, as measured on a visual analogue scale and the Hospital Anxiety and Depression Scale (HADS) questionnaire when compared to control subjects receiving distilled water placebo.

Research Team

Tiffani-Amber Miller, MD

Principal Investigator

University of Florida

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

References

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

Evaluation of aromatherapy in treating postoperative pain: pilot study. [2021]

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. 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]

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

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

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

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

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

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

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

The Effect of Lavender on Sleep Quality in Individuals Without Insomnia: A Systematic Review. [2023]

8. Iran pubmed.ncbi.nlm.nih.gov

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

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

A Feasibility Study of Lavender Aromatherapy in an Awake Craniotomy Environment. [2022]

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

Impact of Lavender on Pain and Anxiety Levels Associated With Spine Procedures. [2022]

11. United States 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. [2022]