Aromatherapy in Total Knee Replacement

Study Overview
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Brief Summary
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The purpose of this pilot randomized controlled trial is to investigate the effects of aromatherapy on postoperative anxiety and pain in total knee replacement patients. The main questions to answer are: Does Lavender-Peppermint Aromatherapy reduce post operative anxiety in patients after primary total knee replacement when compared to placebo? Does Lavender-Peppermint Aromatherapy reduce post operative pain in patient after primary total knee replacement when compared to placebo? Does Lavender-Peppermint Aromatherapy reduce postoperative opioid consumption after primary total knee replacement when compared to placebo? Does Lavender-Peppermint Aromatherapy reduce postoperative nausea and vomiting after primary total knee replacement when compared to placebo? Participants will be assigned to one of the following groups at random: Intervention: Aromatherapy with the lavender-peppermint scent Control: Aromatherapy with the almond oil scent Participants will also be asked to complete pre- and post-operative questionnaires. Researchers will compare both groups (intervention vs control) to see if aromatherapy reduces post-operative anxiety, pain, opioid intake, and nausea/vomiting.

Detailed Description
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Preoperative depression, anxiety, and catastrophizing have all been linked to an increase in postoperative pain and opiate use. Although aromatherapy, specifically lavender, may lower anxiety, no placebo-controlled trial has been undertaken to establish Aromatherapy's therapeutic promise for anxiety after total knee replacement. Although peppermint has been demonstrated to reduce nausea and vomiting, it has not been tested in this population for post-operative nausea and vomiting (PONV). The purpose of this pilot randomized controlled study is to determine the effectiveness of Lavender-Peppermint in reducing post-operative anxiety and discomfort in patients following unilateral primary knee replacement surgery. The study will also monitor individuals throughout the perioperative period to see if aromatherapy intervention reduces PONV and opioid requirement after surgery. The main questions to answer are: Does Lavender-Peppermint Aromatherapy reduce post operative anxiety in patients after primary total knee replacement when compared to placebo? Does Lavender-Peppermint Aromatherapy reduce post operative pain in patient after primary total knee replacement when compared to placebo? Does Lavender-Peppermint Aromatherapy reduce postoperative opioid consumption after primary total knee replacement when compared to placebo? Does Lavender-Peppermint Aromatherapy reduce postoperative nausea and vomiting after primary total knee replacement when compared to placebo? Participants will be assigned to one of the following groups at random: Intervention: Aromatherapy in the lavender-peppermint scent Control: Aromatherapy in the almond oil scent Participants will also be asked to complete pre- and post-operative questionnaires via the following surveys/questionnaires: State-Trait Anxiety Inventory Short Form PROMIS Anxiety v1.0 (short form 8a) PROMIS Depression v1.0 (short form 8a) PROMIS Pain Interference v1.1 (short form 6b) Pain Catastrophizing Scale Pain Rating Scale in Numeric Form Opioid Consumption Opioid Related Symptoms Distress Scale Adverse Events Aromatherapy Satisfaction Questionnaire Bang Blinding Index Researchers will compare both groups (intervention vs control) to see if aromatherapy reduces post-operative anxiety, pain, opioid intake, and vomiting.

Official Title
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Aromatherapy for Post-operative Anxiety and Pain After Primary Unilateral Total Knee Replacement: A Pilot Randomized Controlled Trial

Conditions
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Total Knee Replacement, Post-operative Nausea and Vomiting, Opioid Use, Anxiety, Depression, Post Operative Pain

Intervention / Treatment
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* Other: Elequil Lavender-peppermint Aromatabs
* Other: Elequil Almond-Oil Aromatabs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 and ≤ 80 Scheduled to undergo primary, unilateral knee replacement surgery Willing and able to provide informed consent Willing and able to complete follow-up procedures Intact olfactory function Score 19 or greater on the PROMIS Anxiety Shortform 8A Exclusion Criteria: Score <19 on the PROMIS Emotional Distress - Anxiety - Short Form 8a Current major anxiety or depression Currently taking medications to treat anxiety Impaired sense of smell History of chronic pain with opioid use for greater than 3 months History of Drug or Alcohol abuse History of fibromyalgia History of G6PD deficiency Plant or tree nut allergy Severe allergy to Opioids, NSAIDS or local anesthetics (such as anaphylaxis) Severe liver disease, renal insufficiency (with inability to take acetaminophen or NSAIDS) Non-English Speaking Surgery requiring a hospitalization of greater than 3 days Patient refusal Current cardiac fibrillation Chronic opioid user (>3 months) BMI ≥ 45 Contraindication to neuraxial anesthesia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: A pilot randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lavender-Peppermint Aromatherapy Group<br>This is the interventional group. Participants in this group will receive aromatherapy tabs in the scent of lavender-peppermint. Tabs will be worn on a badge for a total of 72 hours, and participants will replace the aroma tabs every 12 hours. | Other: Elequil Lavender-peppermint Aromatabs<br>* 100% pure essential oils Lavender-peppermint aromatabs purchased through Beekley Medical<br>|
| Placebo Comparator: Almond-oil Aromatherapy Group<br>This is the placebo group. Participants in this group will receive aromatherapy tabs in the scent of almond oil. Tabs will worn on a badge for a total of 72 hours, and participants will replace the aroma tabs every 12 hours. | Other: Elequil Almond-Oil Aromatabs<br>* 100% pure essential oils Almond-oil aromatabs purchased through Beekley Medical<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Anxiety level after surgery | To assess the cumulative change in participants' state anxiety level after surgery. Measured using the State Anxiety Inventory. Scored on the following scale: = not at all = somewhat = moderately so = very much so with 1 being the lowest score and 4 being the highest score. | Measured pre-operatively, in the post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7 | 
| The average pain score after surgery | To assess the average pain score of participants after surgery. Measured using the numerical rating scale (NRS). Measured on a 11-point numeric scale from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable). | Measured pre-operatively, in the post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in depression level before and after surgery | To assess participants' post-operative emotional distress. Measured using the PROMIS depression short form 8a. Scored on the following scale: = never = rarely = sometimes = often = always with 1 being the lowest score and 5 being the highest scores. | Measured pre-operatively and on post-operative day (POD) 7 | 
| Average score on pain catastrophizing | The Pain Catastrophizing Scale is made up of 13 phrases that describe various thoughts and sensations that people may have while they are in pain. The items are assessed on a 5-point scale and are grouped into three categories: rumination, magnification, and helplessness. Scored on the following scale: 0 = Not at all = To a slight degree = To a moderate degree = To a great degree = All the time with 0 being the lowest and 4 being the highest score. | Measured pre-operatively, post-operative day (POD) 1, POD 2, POD 3, POD 7 | 
| Average score on pain interference | The PROMIS Pain Interference instruments (adult) measure the self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Pain Interference also incorporates items probing sleep and enjoyment in life, though the item bank only contains one sleep item. The Pain Interference items utilize a 7-day recall period (items include the phrase the past 7 days). Scored on the following scale: = Not at all = A little bit = Somewhat = Quite a bit = Very much With 1 being the lowest and 5 being the highest | Measured pre-operatively and on post-operative day (POD) 7 | 
| Average post-operative opioid consumption | Self-reported measure of medication, dosage, and time of opioid consumption | Measured in the post-operative care unit (PACU), post-operative day (POD) 1, POD2, POD3, POD7 | 
| Severity of post-operative nausea | To assess, if participants experience post-operative nausea, the severity of the nausea. Measured using the Opioid Related Symptom Distress Scale. If patients experienced nausea, the frequency, severity, and bothersomeness will be assessed. Frequency will be assessed using a 4 point scale: rarely occasionally frequently almost constantly with 1 being the lowest and 4 being the highest. Severity is assessed using a 4 point scale: slight moderate severe very severe with 1 being the lowest and 4 being the highest. Bothersomeness is assessed using a 5 point scale: not at all a little bit somewhat quite a bit very much with 1 being the lowest and 5 being the highest. | Measured at post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7 | 
| Severity of post-operative vomiting | To assess, if participants experience post-operative vomiting, the severity of the vomiting. Measured using the Opioid Related Symptom Distress Scale. If patients experienced vomiting, the number of episodes, severity, and bothersomeness will be assessed. Severity is assessed using a 4 point scale: slight moderate severe very severe with 1 being the lowest and 4 being the highest. Bothersomeness is assessed using a 5 point scale: not at all a little bit somewhat quite a bit very much with 1 being the lowest and 5 being the highest. | Measured at post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7 | 
| Incidences of post-operative complications | To assess the incidences of post-operative complications such as need for ICU admission, DVT/PE, MI, stroke. To be measured in the number of patients who reported adverse events. | Measured at post-anesthesia care unit (PACU) up to post operative day 7 | 
| To assess the severity of opioid-related symptom distress | The Opioid-Related Symptom Distress Scale (ORSDS) is a scale that assesses three dimensions of symptom distress (frequency, severity, and bothersomeness) for 12 symptoms. The symptom-specific ORSDS is calculated by taking the average of the three symptom distress dimensions. Frequency will be assessed using a 4 point scale: rarely occasionally frequently almost constantly with 1 being the lowest and 4 being the highest. Severity is assessed using a 4 point scale: slight moderate severe very severe with 1 being the lowest and 4 being the highest. Bothersomeness is assessed using a 5 point scale: not at all a little bit somewhat quite a bit very much with 1 being the lowest and 5 being the highest. | Measured at post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7 | 
| To assess participants' satisfaction with the aromatherapy | Self-reported responses on a survey of 7-items to assess participants' level of satisfaction with the aromatherapy they received. Measured on the following scale: = Not satisfied = A little bit = Moderately = Quite a bit = Extremely satisfied with 1 being the lowest and 5 being the highest. | Measured at post operative day 7 |