- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT06045078
Aromaterapia täydellisessä polven korvaamisessa
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?
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
New York
-
New York, New York, Yhdysvallat, 10021
- Hospital for Special Surgery
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-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Muut
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Lavender-Peppermint Aromatherapy Group
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. |
100% pure essential oils Lavender-peppermint aromatabs purchased through Beekley Medical |
|
Placebo Comparator: Almond-oil Aromatherapy Group
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. |
100% pure essential oils Almond-oil aromatabs purchased through Beekley Medical |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
State Trait Anxiety Inventory
Aikaikkuna: 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-Trait Anxiety Inventory (STAI). STATE anxiety, with higher scores being worse: For calm, at ease, relaxed, steady: 4 = not at all 3 = somewhat 2 = moderately so 1 = very much so For tense, worrying over misfortunes, frightened, nervous, jittery, worried:
TRAIT anxiety, with higher scores being worse: For self satisfaction, feeling secure, being steady: 4=almost never 3=sometimes 2=often 1=almost always For nervous/restless, wishing to be happier, feeling like a failure, worrying too much, lacking self confidence, feeling inadequate, feeling tension:
STAI is scored as a sum of the scores for state and trait, with 20 being the lowest score (better outcome) and 80 being the highest score (worse outcome). |
Measured pre-operatively, in the post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form 8a Version 1.0
Aikaikkuna: 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:
PROMIS anxiety short form 8a Version 1.0 is scored by calculating the sum of the scores for each question, and using the PROMIS conversion matrix to report the T-score (The T-score is a standardized metric where the United States general population mean is set to 50 with a standard deviation (SD) of 10. Higher T-scores indicate greater levels of anxiety.) |
Measured pre-operatively and on post-operative day (POD) 7
|
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Numeric Rating Scale Pain Scores
Aikaikkuna: 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"). |
Measured pre-operatively, in the post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form 8a
Aikaikkuna: Measured pre-operatively and on post-operative day (POD) 7
|
To assess participants' post-operative emotional distress. Measured using the PROMIS depression short form 8a. Scored on the following scale:
Scored by calculating the sum of the scores for each question, and using the PROMIS conversion matrix to report the T-score. (The T-score is a standardized metric where the United States general population mean is set to 50 with a standard deviation (SD) of 10. Higher T-scores indicate greater levels of anxiety.) |
Measured pre-operatively and on post-operative day (POD) 7
|
|
Pain Catastrophizing Scale
Aikaikkuna: Measured pre-operatively, post-operative day (POD) 1, POD 2, POD 3, POD 7
|
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 (4 questions), magnification (3 questions), and helplessness (6 questions). Scored on the following scale: 0 = Not at all
Scored as the sum of all questions, and the sum of the scores for each question within each subscale. The range for Total Sum: 0 to 52, Rumination: 0 to 16, Magnification: 0 to 12, Helplessness: 0 to 24 |
Measured pre-operatively, post-operative day (POD) 1, POD 2, POD 3, POD 7
|
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Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v1.1 Pain Interference
Aikaikkuna: Measured pre-operatively and on post-operative day (POD) 7
|
The PROMIS SF v1.1 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:
Scored by calculating the sum of the scores for each question, and using the PROMIS conversion matrix to report the T-score. (The T-score is a standardized metric where the United States general population mean is set to 50 with a standard deviation (SD) of 10. Higher T-scores indicate greater levels of anxiety.) |
Measured pre-operatively and on post-operative day (POD) 7
|
|
Post-operative Opioid Consumption
Aikaikkuna: Measured in the post-operative care unit (PACU), post-operative day (POD) 1, POD2, POD3, POD7
|
Self-reported measure of medication, dosage, and time of opioid consumption. Reported as Morphine Milligram equivalents. |
Measured in the post-operative care unit (PACU), post-operative day (POD) 1, POD2, POD3, POD7
|
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Number of Participants With Post-operative Nausea
Aikaikkuna: Measured at post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7
|
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
|
|
Number of Participants With Post-operative Vomiting
Aikaikkuna: Measured at post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7
|
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
|
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Incidences of Post-operative Complications
Aikaikkuna: Measured at post-anesthesia care unit (PACU) up to post operative day 7
|
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
|
|
Opioid-related Symptom Distress Scale
Aikaikkuna: Measured at post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7
|
The Opioid-Related Symptom Distress Scale (ORSDS) assesses opioid-related symptoms across the dimensions of frequency, severity, and bothersomeness. According to the scoring manual, Clinically Meaningful Events (CMEs) are calculated using the symptom severity items only. Severity is rated on a 5-point scale ranging from 0 (did not have symptom) to 4 (very severe). Therefore, scores range from 0 to 4, with higher scores indicating greater symptom severity. |
Measured at post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7
|
|
Participants' Satisfaction With the Aromatherapy
Aikaikkuna: Measured at post operative day 7
|
Self-reported responses on a survey of 7-items to assess participants' level of satisfaction with the aromatherapy they received. Measured on the following scales:
|
Measured at post operative day 7
|
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Aromatab Adherence
Aikaikkuna: Measured on post operative day (POD) 1, POD2, POD3.
|
Feasibility was assessed as the number of Participants that reported "Yes" to wearing each aromatab. |
Measured on post operative day (POD) 1, POD2, POD3.
|
|
Hospital Length of Stay
Aikaikkuna: Measured at discharge as number of hours elapsed between post anesthesia care unit entry and discharge time
|
Hospital length of stay was measured as hours elapsed from post anesthesia care unit entry to discharge, assessed up to 7 days. |
Measured at discharge as number of hours elapsed between post anesthesia care unit entry and discharge time
|
|
Bang Blinding Index
Aikaikkuna: Measured on postoperative day 7
|
The Bang Blinding Index ranges from -1 to 1, where index of 0 indicates random guessing (perfect blinding, better outcome), 1 indicates complete unblinding (all guesses are correct, worse outcome), and -1 indicates complete opposite guessing (all guesses are incorrect, worse outcome). Patients were asked to guess whether the patient was given the intervention (Lavender-Peppermint) or Control (Almond Oil) Aromatherapy. For each arm, calculation of the index score involves subtracting the proportion of respondents assigned to that arm who guess incorrectly from the proportion that guessed correctly. |
Measured on postoperative day 7
|
Yhteistyökumppanit ja tutkijat
Tutkijat
- Päätutkija: Uchenna Umeh, MD, Hospital for Special Surgery, New York
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 2023-1715
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
There is no plan to make IPD available to other researchers.
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