CLINICAL TRIAL

Lavender peppermint elequil aromatab for Postoperative Anxiety

Recruiting · 18+ · All Sexes · Pittsburgh, PA

This study is evaluating whether a lavender scent may help reduce anxiety in patients undergoing surgery.

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About the trial for Postoperative Anxiety

Eligible Conditions
Postoperative Anxiety · Quality of Life (QOL)

Treatment Groups

This trial involves 2 different treatments. Lavender Peppermint Elequil Aromatab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Lavender peppermint elequil aromatab
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Sweet almond oil elequil aromatab
OTHER

Eligibility

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
was significantly reduced in patients who listened to positive self-talk audio recordings before surgery, when compared to those who did not show original
I am willing and able to complete any follow-up procedures necessary. show original
Age > 18 and ≤ 80
The person is scheduled to have surgery on one hip or one or both breasts. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Day of surgery through one month post-operative
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Day of surgery through one month post-operative.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Lavender peppermint elequil aromatab will improve 2 primary outcomes and 10 secondary outcomes in patients with Postoperative Anxiety. Measurement will happen over the course of Day of surgery through one month post-operative.

Opioid Consumption
DAY OF SURGERY THROUGH ONE MONTH POST-OPERATIVE
Investigate the efficacy of aromatherapy in reducing perioperative opioid consumption in opioid naive subjects undergoing unilateral total hip replacement surgery and those undergoing unilateral or bilateral mastectomy.
Change in post-operative anxiety in patients undergoing unilateral hip replacement surgery
DAY OF SURGERY VERSUS 7 DAYS POST-OPERATIVE
Demonstrate the effect of the elequil aromatab (Lavender-Peppermint) versus an active comparator (sweet almond oil) on participant's answers to the PROMIS Emotional Distress-Anxiety-Short Form 8a 7 days following surgery. There are 8 questions about how the participants may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome.
Hospital Readmissions
DAY OF SURGERY THROUGH ONE MONTH POST-OPERATIVE
Determine the number of patients readmitted to the hospital.
Post-operative pain rating using the Visual Analog Scale (VAS)
DAY OF SURGERY THROUGH ONE MONTH POST-OPERATIVE
Post-operative pain ratings will be measured by the assessment of the participant's answers to the Visual Analog Scale (VAS). This measurement is a visual scale from 0-10, with 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10.The participant will be asked to score pain at its best and worst over the period since they were last asked. Higher scores present a worse outcome.
Post-operative pain rating using the Pain Catastrophizing Scale
DAY OF SURGERY THROUGH ONE MONTH POST-OPERATIVE
Post-operative pain ratings will be measured by the assessment of the participant's answers to the Pain Catastrophizing Scale questionnaire. There are 13 statements related to pain that participants will record experiencing on a scale of 0 being experienced not at all to 4 being experienced all of the time. The lowest possible score is 0 and the highest possible score is 52. Higher scores present a worse outcome.
Change in post-operative anxiety
DAY OF SURGERY VERSUS 7 DAYS POST-OPERATIVE
Demonstrate the effect of the elequil aromatab (Lavender-Peppermint) versus an active comparator (sweet almond oil) on participant's answers to the PROMIS Emotional Distress-Anxiety-Short Form 8a 7 days following surgery. There are 8 questions about how the participants may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome.
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Who is running the study

Principal Investigator
J. E. C.
Prof. Jacques E. Chelly, Professor, Anesthesiology and Perioperative Medicine
University of Pittsburgh

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of postoperative anxiety?

Most commonly, patients experience anxiety prior to surgery and immediately following surgery. However, these symptoms are not severe enough to require urgent treatment. Thus, it is important to encourage patients to discuss their potential surgery and coping strategies before surgery with their surgeons. The most common signs/symptoms of anxiety are: fear of the unknown, anxiety related to fear of the unknown, fear of the dark, fear of heights, and fear of animals.

Anonymous Patient Answer

Can postoperative anxiety be cured?

This pilot study does not show conclusive evidence of the possible healing property of acupuncture (or other alternative treatments) on postoperative anxiety. The findings require further research with a larger sample size, larger control group and different follow-up time.

Anonymous Patient Answer

What causes postoperative anxiety?

The development of anxiety after abdominal surgery may be triggered by factors present during operation, but can also be caused by factors which occur after the operation and only a small proportion of patients will develop postoperative anxiety. The cause of postoperative anxiety has profound implications on patient satisfaction and quality of in-hospital care. Psychological interventions such as pre-operative education may help to diminish the development of postoperative anxiety.

Anonymous Patient Answer

How many people get postoperative anxiety a year in the United States?

The current study is the first to evaluate the prevalence and characterize symptoms of POD in the United States with quantitative, validated measures. POD prevalence and characteristics are similar to those reported internationally.

Anonymous Patient Answer

What is postoperative anxiety?

Results from a recent clinical trial demonstrate that postoperative anxiety symptoms were experienced by about 2% of surgical patients and ranged in severity from mild to moderate. The strongest predictor of postoperative anxiety was the number of painful procedures. This is the first study to evaluate the association between clinical variables of anesthesia and postoperative anxiety.

Anonymous Patient Answer

What are common treatments for postoperative anxiety?

This survey revealed some common treatments for patient postoperative anxiety. Most of them should be useful not only for clinical treatment but also in educational contexts.

Anonymous Patient Answer

What are the latest developments in lavender peppermint elequil aromatab for therapeutic use?

The findings of this study suggest that lavender peppermint (Peloria hortorum) may represent a useful treatment option in the treatment of postoperative nausea and vomiting and may prove efficacious and well tolerated with less side phenomena when compared with standard-formula drugs (e.g., ondansetron and metoclopramide) given as prophylaxis for PONV. Further work is required to verify these findings in other patient subpopulations, with further studies to examine the clinical efficacy, duration of action, and safety profile of PPNEE and other nonpharmacological treatments for PONV.

Anonymous Patient Answer

Who should consider clinical trials for postoperative anxiety?

The authors propose that clinical trials for postoperative anxiety should recruit those with a history of postoperative anxiety disorder and consider specific patient characteristics in assessing risk/benefit ratios of possible interventions such as cognitive behavioral therapy (CBT).

Anonymous Patient Answer

How serious can postoperative anxiety be?

Results from a recent clinical trial obtained in the present study indicated no difference in the serious postoperative complications with the use of the modified postoperative anxiety inventory questionnaire in comparison to the American Psychiatric Association (APA) scale. However, the reliability of the APA scale (P = 0.009) may be low for surgical patients.

Anonymous Patient Answer

What does lavender peppermint elequil aromatab usually treat?

Aromatized lavender peppermint, especially lavender peppermint elequil, is a novel method that offers more immediate and powerful effects for postoperative analgesia following ambulatory surgery, and may have potential utility in emergency or critical care settings.

Anonymous Patient Answer

Is lavender peppermint elequil aromatab safe for people?

Use of LEP aromatab by pregnant women, breastfeeding mothers or children caused no apparent harm. Clinical trials are warranted to establish a safe and effective dosage for use by people.

Anonymous Patient Answer

Does lavender peppermint elequil aromatab improve quality of life for those with postoperative anxiety?

Lavender peppermint elequil was safe and well tolerable for use in combination with conventional and alternative methods of care when given before surgery. When compared to Lavender peppermint only, the combination of alternatives and conventional analgesics was the most effective at relieving postoperative anxiety.

Anonymous Patient Answer
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