Total Knee ReplacementNCT06045078
Aromatherapy in Total Knee Replacement
A study testing Elequil Lavender-peppermint Aromatabs and Elequil Almond-Oil Aromatabs in people with Total Knee Replacement and Post-operative Nausea and Vomiting, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Total Knee Replacement, Post-operative Nausea and Vomiting, Opioid Use
- What is being tested?
- Elequil Lavender-peppermint Aromatabs and Elequil Almond-Oil Aromatabs
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2023to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Aromatherapy for Post-operative Anxiety and Pain After Primary Unilateral Total Knee Replacement: A Pilot Randomized Controlled Trial
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?
Read more
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:
- 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 and/or pain.
Read the detailed description
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:
- 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 and/or pain.
- Conditions
- Total Knee Replacement, Post-operative Nausea and Vomiting, Opioid Use, Anxiety, Depression, Post Operative Pain
- Being tested
- Elequil Lavender-peppermint Aromatabs, Elequil Almond-Oil Aromatabs
- Medical subject headings
- Vomiting, Anxiety Disorders, Depression, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elequil Lavender-peppermint AromatabsOther
100% pure essential oils Lavender-peppermint aromatabs purchased through Beekley Medical
Elequil Almond-Oil AromatabsOther
100% pure essential oils Almond-oil aromatabs purchased through Beekley Medical
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Elequil Lavender-peppermint Aromatabs |
| 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. Receives: Other: Elequil Almond-Oil Aromatabs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- = not at all
- = somewhat
- = moderately so
- = very much so
Trait anxiety was scored on the following scale:
- almost never
- sometimes
- often
- almost always with 1 being the lowest score and 4 being the highest score.
Measured: 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:
- = never
- = rarely
- = sometimes
- = often
- = always with 1 being the lowest score and 5 being the highest scores.
Measured: 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: Measured pre-operatively, in the post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7
Secondary outcomes (12)
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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: Measured on postoperative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start3 Oct 2023
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pilot randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uchenna Umeh, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045078
- Sponsor's protocol ID
- 2023-1715
- Status last verified
- Jan 2025
- First submitted
- 13 Sep 2023
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available to other researchers.
Publications
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.
PubMed 34619742Larach 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.
PubMed 31389832Franco 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.
PubMed 27555173Jones 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.
PubMed 34820153Hamzeh 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.
PubMed 32308715Mohr 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.
PubMed 32985338Briggs 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.
PubMed 27333231Lakhan 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.
PubMed 28070420Koulivand 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.
PubMed 23573142Kim 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.
PubMed 17894152Kim 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.
PubMed 17129308Soltani 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.
PubMed 23932834Heidari 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.
PubMed 26261829Nasiri 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.
PubMed 27863613Moeini 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.
PubMed 22049287
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aromatherapy for Post-operative Anxiety and Pain After Primary Unilateral Total Knee Replacement: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06045078
- Acronym / sponsor ID
- 2023-1715
- Conditions
- Total Knee Replacement, Post-operative Nausea and Vomiting, Opioid Use, Anxiety, Depression, Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 and/or pain.
Detailed description
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:
- 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 and/or pain.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A pilot randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Lavender-Peppermint Aromatherapy Group | Experimental | Other: Elequil Lavender-peppermint AromatabsThis 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 | Other: Elequil Almond-Oil AromatabsThis 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elequil Lavender-peppermint Aromatabs100% pure essential oils Lavender-peppermint aromatabs purchased through Beekley Medical | Other | Lavender-Peppermint Aromatherapy Group |
| Elequil Almond-Oil Aromatabs100% pure essential oils Almond-oil aromatabs purchased through Beekley Medical | Other | Almond-oil Aromatherapy Group |
Primary outcome
Changes in Anxiety level before and each individual day after surgery.
Time frame: Measured pre-operatively, in the post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7
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.
Difference in anxiety level before and after surgery
Time frame: Measured pre-operatively and on post-operative day (POD) 7
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.
The average pain score after surgery
Time frame: Measured pre-operatively, in the post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7
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").
12 secondary outcomes
Difference in depression level before and after surgery
Time frame: Measured pre-operatively and on post-operative day (POD) 7
Average score on pain catastrophizing
Time frame: Measured pre-operatively, post-operative day (POD) 1, POD 2, POD 3, POD 7
Average score on pain interference
Time frame: Measured pre-operatively and on post-operative day (POD) 7
Average post-operative 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
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
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
Time frame: Measured at post-anesthesia care unit (PACU) up to post operative day 7
To assess the severity of opioid-related symptom distress
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
Time frame: Measured at post operative day 7
Aromatab Adherence
Time frame: Measured on post operative day (POD) 1, POD2, POD3.
Hospital Length of Stay
Time frame: Measured at discharge as number of hours elapsed between post anesthesia care unit entry and discharge time
Bang Blinding Index
Time frame: Measured on postoperative day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Results publication: PubMed 34619742Carey 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.
- Results publication: PubMed 31389832Larach 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.
- Results publication: PubMed 27555173Franco 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.
- Results publication: PubMed 34820153Jones 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.
- Results publication: PubMed 32308715Hamzeh 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.
- Results publication: PubMed 32985338Mohr 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.
- Results publication: PubMed 27333231Briggs 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.
- Results publication: PubMed 28070420Lakhan 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.
- Results publication: PubMed 23573142Koulivand 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.
- Results publication: PubMed 17894152Kim 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.
- Results publication: PubMed 17129308Kim 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.
- Results publication: PubMed 23932834Soltani 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.
- Individual participant dataSharing planned: No. There is no plan to make IPD available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uchenna Umeh, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elequil Lavender-peppermint Aromatabs and Elequil Almond-Oil Aromatabs in people with Total Knee Replacement and Post-operative Nausea and Vomiting, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Anxiety level before and each individual day after surgery. (time frame: Measured pre-operatively, in the post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06045078, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025; AzTrials last refreshed its copy on 28 Oct 2026.