Aromatherapy for Pre-Procedure Anxiety

Overseen By Chane Price, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Must not be taking: Benzodiazepines

Disqualifiers: Impaired smell, Asthma, Migraines, others

Compensation: Varies

Number of Visits: 1

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how lavender essential oil might reduce anxiety before certain medical procedures involving muscles and joints. Researchers aim to determine if inhaling this scent can calm patients more effectively than water on their masks. Individuals undergoing ultrasound-guided procedures, such as joint injections, and who speak English may qualify for this study. However, it is not suitable for those with asthma, lavender allergies, or those currently taking anxiety medications. As an unphased study, this trial provides a unique opportunity to explore natural anxiety relief methods before medical procedures.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently on benzodiazepine anxiolytic therapy (a type of medication for anxiety).

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that using lavender essential oil in aromatherapy is generally safe. Studies have found that it can reduce anxiety without causing drowsiness or serious side effects. One study highlighted that lavender aromatherapy is a safe way to treat anxiety due to its ease of use and lack of major problems.

While some essential oils can be harmful, lavender is usually well-tolerated. Most research reports positive effects on anxiety with minimal risk. For those considering joining a clinical trial for lavender aromatherapy, current research suggests it is likely safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about aromatherapy for pre-procedure anxiety because it offers a natural and non-invasive alternative to traditional anxiety treatments like sedatives or anti-anxiety medications. Unlike these standard options, which can have side effects and require time to take effect, aromatherapy uses lavender essential oil applied to a mask, potentially calming patients quickly and without medication. This method leverages the soothing properties of lavender, which are believed to help reduce stress and anxiety, providing a simple and fast-acting approach to ease patients' nerves before procedures.

What evidence suggests that aromatherapy might be an effective treatment for pre-procedure anxiety?

Research has shown that aromatherapy, particularly with lavender essential oil, can reduce anxiety before medical procedures. In this trial, participants in the aromatherapy group will have lavender essential oil applied to their surgical mask for 5 minutes before their procedure. Past studies found that people using aromatherapy felt significantly less anxious than those without any treatment. One analysis found a noticeable difference, with patients feeling less anxious overall. Another study showed that aromatherapy reduced anxiety by nearly 4 points on a scale, which is quite significant. These findings suggest that lavender aromatherapy could effectively ease anxiety in patients before their procedures. ^{2 6 7 8 9}

Who Is on the Research Team?

Tricia Prince, DO

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for English-speaking adults scheduled for certain pain relief procedures like medial branch blocks or epidural injections. It's not open to those who can't consent, have a poor sense of smell, dislike or are allergic to lavender, suffer from migraines, asthma, have anxiety disorders on treatment, are pregnant women, prisoners or minors.

Inclusion Criteria

Proficient with English

I am having an ultrasound-guided procedure for a joint or soft tissue issue.

Exclusion Criteria

I have asthma.

Pregnant women

I am unable to give consent for medical procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Pre-procedure

Participants receive either lavender essential oil or placebo applied to their surgical mask for 5 minutes prior to the ultrasound guided musculoskeletal procedure

5 minutes

1 visit (in-person)

Procedure

Participants undergo the ultrasound guided musculoskeletal procedure

Up to 60 minutes

Follow-up

Participants are monitored for anxiety levels and procedure outcomes

Up to 60 minutes post-procedure

What Are the Treatments Tested in This Trial?

Interventions

• Aromatherapy
• Placebo

Trial Overview The study aims to see if smelling lavender oil before ultrasound-guided musculoskeletal procedures can help reduce anxiety compared to a placebo (a substance with no therapeutic effect).

How Is the Trial Designed?

Group I: Aromatherapy group Experimental Treatment 1 Intervention

Participants in this group will receive, lavender essential oil applied to their surgical mask for 5 minutes prior to scheduled standard of care ultrasound guided musculoskeletal procedure.

Group II: Placebo group Placebo Group 1 Intervention

Participants in this group will receive water applied to their surgical mask for 5 minutes prior to scheduled standard of care ultrasound guided musculoskeletal procedure.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Published Research Related to This Trial

Aromatherapy, particularly using lavender and orange fragrances, may help reduce dental anxiety compared to no treatment, as indicated by improvements in physiological and psychological measures.

However, the evidence supporting these findings is of low to very low certainty, highlighting the need for more rigorous studies to confirm the effectiveness of aromatherapy in managing dental anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of aromatherapy on dental anxiety: A systematic review of randomised and quasi-randomised controlled trials. Cai, H., Xi, P., Zhong, L., et al.[2022]

Aromatherapy significantly reduced preoperative anxiety in adult surgical patients, with a mean decrease of 17.42 points on the State Trait Anxiety Inventory, far exceeding the benchmark for clinical significance.

The majority of participants (96%) expressed a willingness to use aromatherapy again before surgery, and 91% reported increased satisfaction with their perioperative care, suggesting that aromatherapy not only alleviates anxiety but also enhances the overall patient experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of Aromatherapy, a Nonpharmacological Intervention, to Reduce Anxiety During the Preoperative Period. Honig, AJ., Galassi, MG., Ogungbe, OO., et al.[2023]

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 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]

In a study of 150 adult surgical patients, the use of essential oil lavandin significantly reduced preoperative anxiety compared to standard care, indicating its potential as an effective, low-risk intervention.

The lavandin group experienced lower anxiety levels during transfer to the operating room, suggesting that incorporating essential oils could enhance patient satisfaction and improve preoperative outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of the essential oil lavandin to reduce preoperative anxiety in surgical patients. Braden, R., Reichow, S., Halm, MA.[2016]

Lavender aromatherapy significantly reduced the need for midazolam, an anxiolytic medication, in patients undergoing cesarean sections under spinal anesthesia, indicating its potential as a safe alternative for managing preoperative anxiety.

The study involved 96 patients and demonstrated that lavender aromatherapy not only helped lower anxiety levels but also contributed to patient satisfaction without increasing intraoperative complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of lavender aromatherapy on the level of intraoperative anxiety in caesarean case under spinal anesthesia: A randomized controlled trial. Çalışır, F., Urfalıoğlu, A., Bilal, B., et al.[2023]

Inhalation aromatherapy using lavender oil significantly reduced anxiety levels in preoperative patients, with scores dropping from an average of 51.00 to 38.61 after the intervention, compared to a minimal change in the control group.

This study involved 72 patients undergoing heart and abdominal surgery, demonstrating that aromatherapy can be an effective complementary treatment to help manage anxiety before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of inhalation aromatherapy on anxiety level of the patients in preoperative period. Fayazi, S., Babashahi, M., Rezaei, M.[2022]

This systematic review aims to evaluate the effectiveness of aromatherapy in treating various medical conditions, using randomized trials to compare aromatherapy against inactive controls, massage alone, and standard treatments.

The review will analyze outcomes related to pain, emotional functioning, and sleep disruption across different populations, providing a comprehensive synthesis of current evidence on aromatherapy's therapeutic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of aromatherapy for prevention or treatment of disease, medical or preclinical conditions, and injury: protocol for a systematic review and meta-analysis. Brennan, SE., McDonald, S., Murano, M., et al.[2022]

Aromatherapy significantly reduces preoperative anxiety in adult patients, with a meta-analysis of 10 randomized controlled trials involving 750 patients showing a mean difference of -3.95 compared to control groups.

Despite the positive findings, the study highlights methodological limitations in the included trials, indicating a need for more rigorously designed research to confirm the efficacy of aromatherapy as a treatment for preoperative anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of aromatherapy on preoperative anxiety in adult patients: A meta-analysis of randomized controlled trials. Huang, H., Wang, Q., Guan, X., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32861206/

The effectiveness of aromatherapy on preoperative anxiety ... The meta-analysis indicated that aromatherapy could significantly ameliorate preoperative anxiety (standard mean difference=-0.57, 95% confidence interval [- ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1744388121000013

Effect of aromatherapy on preoperative anxiety in adult ... Aromatherapy was found to decrease preoperative anxiety significantly compared to the control group (MD = −3.95, 95%CI [-6.36, −1.53], P = 0.001).

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12180096/

The Effect of Aromatherapy on Pain and Anxiety Levels Before ... Some research has suggested that aromatherapy may be beneficial in reducing procedural anxiety and pain in similar interventional settings, such ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S016503271933160X

Effects of aromatherapy on anxiety: A meta-analysis ... The meta-analysis suggested that aromatherapy with different essential oils could alleviate anxiety significantly no matter the reason of anxiety.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06133868

The Efficacy of Lavender and Chamomile Essential Oils ... Chamomile also functions by stimulating the release of cortisol, has been found to alleviate anxiety. Previous studies have investigated the effects of this ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7520654/

Clinical Aromatherapy - PMC - PubMed Central - NIH It is beneficial for preoperative anxiety, oncology, palliative care, hospice, and end of life. Essential oils can be dangerous and toxic, with ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10267315/

Essential oils for treating anxiety: a systematic review of ... A randomized controlled trial examining the effect of aromatherapy using the damask rose essential oil on pre-operative anxiety levels.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1744388123000312

Benefit of inhalation aromatherapy as a complementary ... Over 70% of the studies reported a positive effect on anxiety levels in the aromatherapy intervention groups compared with the control. However, in many cases ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT01837966

NCT01837966 | Randomized, Placebo-Controlled Study: ... Lavender aromatherapy is an alternative treatment for anxiety which is safe, inexpensive, easy to administer, and not overly sedating. In addition to its ...