An interventional study of Elequil Lavender-peppermint Aromatabs and Elequil Almond-Oil Aromatabs in Total Knee Replacement, Post-operative Nausea and Vomiting and Opioid Use, sponsored by Hospital for Special Surgery, New York. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-01-27.
Sponsored by Hospital for Special Surgery, New York · Not applicable, Interventional, and Other
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 primary research questions 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?
Participants will be assigned to one of the following groups at random:
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 and/or pain.
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 primary research questions 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?
Participants will be assigned to one of the following groups at random:
Participants will also be asked to complete pre- and post-operative questionnaires via the following surveys/questionnaires:
Researchers will compare both groups (intervention vs control) to see if aromatherapy reduces post-operative anxiety and/or pain.
1,123 studies on the registry are indexed under Vomiting; 137 are open to participants now.
This study's enrollment of 30 is below the median of 105 across 954 interventional studies indexed under Vomiting.
Browse Vomiting studies →Hospital for Special Surgery, New York is the lead sponsor of 226 studies on the registry; 40 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 22 (73%) have results posted.
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Exclusion Criteria:
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
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
100% pure essential oils Lavender-peppermint aromatabs purchased through Beekley Medical
100% pure essential oils Almond-oil aromatabs purchased through Beekley Medical
Changes in Anxiety level before and each individual day after surgery.
To assess the change in participants' anxiety level before and each individual day after surgery. Measured using the State Anxiety Inventory. State anxiety was scored on the following scale: 1. = not at all 2. = somewhat 3. = moderately so 4. = very much so Trait anxiety was scored on the following scale: 1. almost never 2. sometimes 3. often 4. almost always with 1 being the lowest score and 4 being the highest score.
Time frame: Measured pre-operatively, in the post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7
Difference in anxiety level before and after surgery
To assess participants' preoperative (cumulative 7 days before surgery) and postoperative (cumulative 7 days after surgery) anxiety. Measured using the PROMIS anxiety short form 8a Version 1.0. Scored on the following scale: 1. = never 2. = rarely 3. = sometimes 4. = often 5. = always with 1 being the lowest score and 5 being the highest scores.
Time frame: Measured pre-operatively and on post-operative day (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").
Time frame: Measured pre-operatively, in the post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7
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: 1. = never 2. = rarely 3. = sometimes 4. = often 5. = always with 1 being the lowest score and 5 being the highest scores.
Time frame: 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 1. = To a slight degree 2. = To a moderate degree 3. = To a great degree 4. = All the time with 0 being the lowest and 4 being the highest score.
Time frame: 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: 1. = Not at all 2. = A little bit 3. = Somewhat 4. = Quite a bit 5. = Very much With 1 being the lowest and 5 being the highest
Time frame: 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
Time frame: Measured in the post-operative care unit (PACU), post-operative day (POD) 1, POD2, POD3, POD7
Presence of post-operative nausea
To assess if participants experience post-operative nausea. Measured using the Opioid Related Symptom Distress Scale question: In the past 24 hours, I had nausea (yes/no).
Time frame: Measured at post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7
Presence of post-operative vomiting
To assess if participants experience post-operative vomiting. Measured using the Opioid Related Symptom Distress Scale question: In the past 24 hours, I had vomiting (yes/no).
Time frame: 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.
Time frame: 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: 1. rarely 2. occasionally 3. frequently 4. almost constantly with 1 being the lowest and 4 being the highest. Severity is assessed using a 4 point scale: 1. slight 2. moderate 3. severe 4. very severe with 1 being the lowest and 4 being the highest. Bothersomeness is assessed using a 5 point scale: 1. not at all 2. a little bit 3. somewhat 4. quite a bit 5. very much with 1 being the lowest and 5 being the highest.
Time frame: 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: 1. = Not satisfied 2. = A little bit 3. = Moderately 4. = Quite a bit 5. = Extremely satisfied with 1 being the lowest and 5 being the highest.
Time frame: Measured at post operative day 7
Aromatab Adherence
Feasibility was assessed as adherence to aromatab protocol was assessed as yes/no for whether the patient wore each of the 6 aromatabs.
Time frame: Measured on post operative day (POD) 1, POD2, POD3.
Hospital Length of Stay
Hospital length of stay was measured as hours elapsed from post anesthesia care unit entry to discharge.
Time frame: Measured at discharge as number of hours elapsed between post anesthesia care unit entry and discharge time
Bang Blinding Index
The Bang Blinding Index ranges from -1 to 1, where index of 1 indicates all responses are correct and complete unblinding is inferred. Patients and Research Assistants were asked to guess whether the patient was given the intervention (Lavender-Peppermint) or Control (Almond Oil) Aromatherapy.
Time frame: Measured on postoperative day 7
Plan to share: No — There is no plan to make IPD available to other researchers.
Ran from Oct 2023 to primary completion in Apr 2024, 5 months.
Of 230 non-industry interventional studies with no phase under Vomiting, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 26. This study's 5 months is below that.
Counting every sponsor, half of 234 studies reached it within 12 months; a quarter within 6 and three quarters within 27.
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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