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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lavender-Peppermint Aromatherapy Group | Experimental | 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. |
|
| Almond-oil Aromatherapy Group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elequil Lavender-peppermint Aromatabs | Other | 100% pure essential oils Lavender-peppermint aromatabs purchased through Beekley Medical |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
Trait anxiety was scored on the following scale:
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 |
| 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:
| 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"). | Measured pre-operatively, in the post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7 |
| 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:
| Measured pre-operatively and on post-operative day (POD) 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Uchenna Umeh, MD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34619742 | Result | Carey ET, Moore KJ, Young JC, Bhattacharya M, Schiff LD, Louie MY, Park J, Strassle PD. Association of Preoperative Depression and Anxiety With Long-term Opioid Use After Hysterectomy for Benign Indications. Obstet Gynecol. 2021 Nov 1;138(5):715-724. doi: 10.1097/AOG.0000000000004568. | |
| 31389832 | Result | Larach DB, Sahara MJ, As-Sanie S, Moser SE, Urquhart AG, Lin J, Hassett AL, Wakeford JA, Clauw DJ, Waljee JF, Brummett CM. Patient Factors Associated With Opioid Consumption in the Month Following Major Surgery. Ann Surg. 2021 Mar 1;273(3):507-515. doi: 10.1097/SLA.0000000000003509. |
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There is no plan to make IPD available to other researchers.
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 18, 2026 |
| ID | Term |
|---|---|
| D014839 | Vomiting |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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A pilot randomized controlled trial
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Research staff (i.e. research assistants, coordinators, etc.)
| Elequil Almond-Oil Aromatabs | Other | 100% pure essential oils Almond-oil aromatabs purchased through Beekley Medical |
|
| 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
| 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:
| 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 |
| 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). | 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). | 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:
Severity is assessed using a 4 point scale:
Bothersomeness is assessed using a 5 point scale:
| 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:
| 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. | 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. | 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. | Measured on postoperative day 7 |
| 27555173 | Result | Franco L, Blanck TJ, Dugan K, Kline R, Shanmugam G, Galotti A, von Bergen Granell A, Wajda M. Both lavender fleur oil and unscented oil aromatherapy reduce preoperative anxiety in breast surgery patients: a randomized trial. J Clin Anesth. 2016 Sep;33:243-9. doi: 10.1016/j.jclinane.2016.02.032. Epub 2016 May 5. |
| 34820153 | Result | Jones T, Purdy M, Stewart EA, Cutshall SM, Hathcock MA, Mahapatra S, Bauer BA, Ainsworth AJ. Lavender Aromatherapy to Reduce Anxiety During Intrauterine Insemination: A Randomized Controlled Trial. Glob Adv Health Med. 2021 Nov 17;10:21649561211059074. doi: 10.1177/21649561211059074. eCollection 2021. |
| 32308715 | Result | Hamzeh S, Safari-Faramani R, Khatony A. Effects of Aromatherapy with Lavender and Peppermint Essential Oils on the Sleep Quality of Cancer Patients: A Randomized Controlled Trial. Evid Based Complement Alternat Med. 2020 Mar 25;2020:7480204. doi: 10.1155/2020/7480204. eCollection 2020. |
| 32985338 | Result | Mohr C, Jensen C, Padden N, Besel JM, Brant JM. Peppermint Essential Oil for Nausea and Vomiting in Hospitalized Patients: Incorporating Holistic Patient Decision Making Into the Research Design. J Holist Nurs. 2021 Jun;39(2):126-134. doi: 10.1177/0898010120961579. Epub 2020 Sep 27. |
| 27333231 | Result | Briggs P, Hawrylack H, Mooney R. Inhaled peppermint oil for postop nausea in patients undergoing cardiac surgery. Nursing. 2016 Jul;46(7):61-7. doi: 10.1097/01.NURSE.0000482882.38607.5c. |
| 28070420 | Result | Lakhan SE, Sheafer H, Tepper D. The Effectiveness of Aromatherapy in Reducing Pain: A Systematic Review and Meta-Analysis. Pain Res Treat. 2016;2016:8158693. doi: 10.1155/2016/8158693. Epub 2016 Dec 14. |
| 23573142 | Result | Koulivand PH, Khaleghi Ghadiri M, Gorji A. Lavender and the nervous system. Evid Based Complement Alternat Med. 2013;2013:681304. doi: 10.1155/2013/681304. Epub 2013 Mar 14. |
| 17894152 | Result | Kim JT, Ren CJ, Fielding GA, Pitti A, Kasumi T, Wajda M, Lebovits A, Bekker A. Treatment with lavender aromatherapy in the post-anesthesia care unit reduces opioid requirements of morbidly obese patients undergoing laparoscopic adjustable gastric banding. Obes Surg. 2007 Jul;17(7):920-5. doi: 10.1007/s11695-007-9170-7. |
| 17129308 | Result | Kim JT, Wajda M, Cuff G, Serota D, Schlame M, Axelrod DM, Guth AA, Bekker AY. Evaluation of aromatherapy in treating postoperative pain: pilot study. Pain Pract. 2006 Dec;6(4):273-7. doi: 10.1111/j.1533-2500.2006.00095.x. |
| 23932834 | Result | Soltani R, Soheilipour S, Hajhashemi V, Asghari G, Bagheri M, Molavi M. Evaluation of the effect of aromatherapy with lavender essential oil on post-tonsillectomy pain in pediatric patients: a randomized controlled trial. Int J Pediatr Otorhinolaryngol. 2013 Sep;77(9):1579-81. doi: 10.1016/j.ijporl.2013.07.014. Epub 2013 Aug 8. |
| 26261829 | Result | Heidari Gorji MA, Ashrastaghi OG, Habibi V, Charati JY, Ebrahimzadeh MA, Ayasi M. The effectiveness of lavender essence on strernotomy related pain intensity after coronary artery bypass grafting. Adv Biomed Res. 2015 Jun 4;4:127. doi: 10.4103/2277-9175.158050. eCollection 2015. |
| 27863613 | Result | Nasiri A, Mahmodi MA, Nobakht Z. Effect of aromatherapy massage with lavender essential oil on pain in patients with osteoarthritis of the knee: A randomized controlled clinical trial. Complement Ther Clin Pract. 2016 Nov;25:75-80. doi: 10.1016/j.ctcp.2016.08.002. Epub 2016 Aug 3. |
| 22049287 | Result | Moeini M, Khadibi M, Bekhradi R, Mahmoudian SA, Nazari F. Effect of aromatherapy on the quality of sleep in ischemic heart disease patients hospitalized in intensive care units of heart hospitals of the Isfahan University of Medical Sciences. Iran J Nurs Midwifery Res. 2010 Fall;15(4):234-9. |
| 22588767 | Result | Julian LJ. Measures of anxiety: State-Trait Anxiety Inventory (STAI), Beck Anxiety Inventory (BAI), and Hospital Anxiety and Depression Scale-Anxiety (HADS-A). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S467-72. doi: 10.1002/acr.20561. No abstract available. |
| 34196978 | Result | Recklitis CJ, Blackmon JE, Chevalier LL, Chang G. Validating the Patient-Reported Outcomes Measurement Information System Short Form v1.0-Anxiety 8a in a sample of young adult cancer survivors: Comparison with a structured clinical diagnostic interview. Cancer. 2021 Oct 1;127(19):3691-3697. doi: 10.1002/cncr.33683. Epub 2021 Jul 1. |
| 21697139 | Result | Pilkonis PA, Choi SW, Reise SP, Stover AM, Riley WT, Cella D; PROMIS Cooperative Group. Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS(R)): depression, anxiety, and anger. Assessment. 2011 Sep;18(3):263-83. doi: 10.1177/1073191111411667. Epub 2011 Jun 21. |
| 35857151 | Result | Clover K, Lambert SD, Oldmeadow C, Britton B, Mitchell AJ, Carter G, King MT. Convergent and criterion validity of PROMIS anxiety measures relative to six legacy measures and a structured diagnostic interview for anxiety in cancer patients. J Patient Rep Outcomes. 2022 Jul 20;6(1):80. doi: 10.1186/s41687-022-00477-4. |
| 40828687 | Derived | Tailor M, Illescas A, Zhong H, Long WJ, Lin Y, Umeh UO. Aromatherapy for Anxiety and Pain After Total Knee Replacement: A Pilot Randomized Controlled Trial. Anesth Analg. 2026 Mar 1;142(3):602-605. doi: 10.1213/ANE.0000000000007711. Epub 2025 Aug 19. No abstract available. |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |