Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2023-10-03
2024-04-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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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.
Elequil Lavender-peppermint Aromatabs
100% pure essential oils Lavender-peppermint aromatabs purchased through Beekley Medical
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.
Elequil Almond-Oil Aromatabs
100% pure essential oils Almond-oil aromatabs purchased through Beekley Medical
Interventions
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Elequil Lavender-peppermint Aromatabs
100% pure essential oils Lavender-peppermint aromatabs purchased through Beekley Medical
Elequil Almond-Oil Aromatabs
100% pure essential oils Almond-oil aromatabs purchased through Beekley Medical
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Hospital for Special Surgery, New York
OTHER
Responsible Party
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Principal Investigators
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Uchenna Umeh, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital for Special Surgery, New York
Locations
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Hospital for Special Surgery
New York, New York, United States
Countries
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References
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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.
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Other Identifiers
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2023-1715
Identifier Type: -
Identifier Source: org_study_id
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