Clinical trial NCT06045078: Aromatherapy in Total Knee Replacement
Official title: Aromatherapy for Post-operative Anxiety and Pain After Primary Unilateral Total Knee Replacement: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Replacement
Post-operative Nausea and Vomiting
Opioid Use
Anxiety
Depression
Post Operative Pain
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pilot randomized controlled trial
Primary purpose: OTHER

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Anxiety level before and each individual day after surgery.
timeFrame: Measured pre-operatively, in the post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7
measure: Difference in anxiety level before and after surgery
timeFrame: Measured pre-operatively and on post-operative day (POD) 7
measure: The average pain score after surgery
timeFrame: Measured pre-operatively, in the post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7
Secondary outcomes:
measure: Difference in depression level before and after surgery
timeFrame: Measured pre-operatively and on post-operative day (POD) 7
measure: Average score on pain catastrophizing
timeFrame: Measured pre-operatively, post-operative day (POD) 1, POD 2, POD 3, POD 7
measure: Average score on pain interference
timeFrame: Measured pre-operatively and on post-operative day (POD) 7
measure: Average post-operative opioid consumption
timeFrame: Measured in the post-operative care unit (PACU), post-operative day (POD) 1, POD2, POD3, POD7
measure: Presence of post-operative nausea
timeFrame: Measured at post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7
measure: Presence of post-operative vomiting
timeFrame: Measured at post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7
measure: Incidences of post-operative complications
timeFrame: Measured at post-anesthesia care unit (PACU) up to post operative day 7
measure: To assess the severity of opioid-related symptom distress
timeFrame: Measured at post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7
measure: To assess participants' satisfaction with the aromatherapy
timeFrame: Measured at post operative day 7
measure: Aromatab Adherence
timeFrame: Measured on post operative day (POD) 1, POD2, POD3.
measure: Hospital Length of Stay
timeFrame: Measured at discharge as number of hours elapsed between post anesthesia care unit entry and discharge time
measure: Bang Blinding Index
timeFrame: Measured on postoperative day 7
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Uchenna Umeh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Consensus Conference on 'Follow-up of Breast Cancer Patients'. Ann Oncol. 1995;6 Suppl 2:69-70. No abstract available.
citation: Hunter JA, Zoma AA, Scullion JE, Protheroe K, Young AB, Sturrock RD, Capell HA. The geometric knee replacement in polyarthritis. J Bone Joint Surg Br. 1982;64(1):95-8. doi: 10.1302/0301-620X.64B1.7068729.
citation: 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.
citation: Wojcik A, Bonk K, Muller WU, Obe G, Streffer C. Do DNA double-strand breaks induced by Alu I lead to development of novel aberrations in the second and third post-treatment mitoses? Radiat Res. 1996 Feb;145(2):119-27.
citation: Cunha GR, Shannon JM, Vanderslice KD, Sekkingstad M, Robboy SJ. Autoradiographic analysis of nuclear estrogen binding sites during postnatal development of the genital tract of female mice. J Steroid Biochem. 1982 Sep;17(3):281-6. doi: 10.1016/0022-4731(82)90201-1.
citation: 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.
citation: 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.
citation: Haward LR. Some psychological aspects of pregnancy. 16. Midwives Chron. 1969 May;83(976):171-2. No abstract available.
citation: Woodall DL, Birken GA, Williamson K, Lobe TE. Isolated fetal-neonatal abdominal ascites: a sign of intrauterine intussusception. J Pediatr Surg. 1987 Jun;22(6):506-7. doi: 10.1016/s0022-3468(87)80207-5. No abstract available.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Karanika-Kouma A, Trigonidis G. [Pulpal reaction after the use of a glass ionomer cement as a cavity liner. An experimental study]. Hell Stomatol Chron. 1987 Jul-Sep;31(3):199-203. No abstract available. Greek, Modern.
citation: 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.