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Completed

NCT Number: NCT06045078

Aromatherapy in Total Knee Replacement

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.

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Key information

Conditions

Total Knee Replacement Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Neurologic Manifestations Opioid Use Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Pain Post-operative Nausea and Vomiting Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Special Surgery

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elequil Lavender-peppermint Aromatabs

Other

100% pure essential oils Lavender-peppermint aromatabs purchased through Beekley Medical

Elequil Almond-Oil Aromatabs

Other

100% pure essential oils Almond-oil aromatabs purchased through Beekley Medical

Primary outcomes

  1. 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:

    • = 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.

  2. 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:

    • = never
    • = rarely
    • = sometimes
    • = often
    • = always with 1 being the lowest score and 5 being the highest scores.

  3. 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").

Secondary outcomes

  1. Difference in depression level before and after surgery

    Time frame: 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:

    • = never
    • = rarely
    • = sometimes
    • = often
    • = always with 1 being the lowest score and 5 being the highest scores.

  2. Average score on pain catastrophizing

    Time frame: 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, 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.

  3. Average score on pain interference

    Time frame: Measured pre-operatively and on post-operative day (POD) 7

    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

  4. Average post-operative opioid consumption

    Time frame: 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

  5. 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

    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).

  6. 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

    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).

  7. Incidences of post-operative complications

    Time frame: 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.

  8. 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

    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.

  9. To assess participants' satisfaction with the aromatherapy

    Time frame: 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 scale:

    • = Not satisfied
    • = A little bit
    • = Moderately
    • = Quite a bit
    • = Extremely satisfied with 1 being the lowest and 5 being the highest.

  10. Aromatab Adherence

    Time frame: Measured on post operative day (POD) 1, POD2, POD3.

    Feasibility was assessed as adherence to aromatab protocol was assessed as yes/no for whether the patient wore each of the 6 aromatabs.

  11. Hospital Length of Stay

    Time frame: 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.

  12. Bang Blinding Index

    Time frame: Measured on postoperative day 7

    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.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

Aromatherapy for Post-operative Anxiety and Pain After Primary Unilateral Total Knee Replacement: A Pilot Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 21, 2023
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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