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

Trial Summary

What is the purpose of this trial?

The goal of this study is to evaluate the effect of lavender essential oil on pre-procedure anxiety for patients undergoing ultrasound guided musculoskeletal 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).

What data supports the effectiveness of the treatment Aromatherapy for reducing pre-procedure anxiety?

Research shows that using lavender aromatherapy can help reduce anxiety before surgery. Studies found that patients who used lavender essential oil felt less anxious compared to those who received standard care, making it a simple and low-risk way to improve patient comfort. ^{1 2 3 4 5}

Is aromatherapy safe for reducing pre-procedure anxiety?

Aromatherapy, which uses essential oils from plants, is generally considered a low-risk and safe method for managing anxiety before medical procedures. ^{1 2 3 6 7}

How does aromatherapy differ from other treatments for pre-procedure anxiety?

Aromatherapy, particularly using lavender essential oil, is unique because it is a natural, non-invasive treatment that involves inhaling the scent of essential oils to help reduce anxiety. Unlike medications, it does not involve ingesting or injecting substances, making it a low-risk and cost-effective option for managing anxiety before medical procedures. ^{1 2 3 8 9}

Research Team

Tricia Prince, DO

Principal Investigator

University of Miami

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

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

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

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. India pubmed.ncbi.nlm.nih.gov

The effect of inhalation aromatherapy on anxiety level of the patients in preoperative period. [2022]

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

Implementation of Aromatherapy, a Nonpharmacological Intervention, to Reduce Anxiety During the Preoperative Period. [2023]

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

The use of the essential oil lavandin to reduce preoperative anxiety in surgical patients. [2016]

6. England 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. [2022]

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

Effect of aromatherapy on preoperative anxiety in adult patients: A meta-analysis of randomized controlled trials. [2021]

8. United States 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. [2023]

9. Denmark pubmed.ncbi.nlm.nih.gov

Efficacy of aromatherapy on dental anxiety: A systematic review of randomised and quasi-randomised controlled trials. [2022]