Aromatherapy in Total Knee Replacement

April 19, 2024 updated by: Hospital for Special Surgery, New York

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 main questions to answer 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?

Does Lavender-Peppermint Aromatherapy reduce postoperative opioid consumption after primary total knee replacement when compared to placebo?

Does Lavender-Peppermint Aromatherapy reduce postoperative nausea and vomiting 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, pain, opioid intake, and nausea/vomiting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 study will also monitor individuals throughout the perioperative period to see if aromatherapy intervention reduces PONV and opioid requirement after surgery.

The main questions to answer 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?

Does Lavender-Peppermint Aromatherapy reduce postoperative opioid consumption after primary total knee replacement when compared to placebo?

Does Lavender-Peppermint Aromatherapy reduce postoperative nausea and vomiting 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, pain, opioid intake, and vomiting.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Pa Thor, PhD
  • Phone Number: 646-797-8535
  • Email: thorp@hss.edu

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Hospital for Special Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Elequil Lavender-peppermint Aromatabs
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.
Other: Elequil Almond-Oil Aromatabs
100% pure essential oils Almond-oil aromatabs purchased through Beekley Medical

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Anxiety level 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 cumulative change in participants' state anxiety level after surgery. Measured using the State Anxiety Inventory. Scored on the following scale:

  1. = not at all
  2. = somewhat
  3. = moderately so
  4. = very much so

with 1 being the lowest score and 4 being the highest score.
Measured pre-operatively, in the post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7
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").
Measured pre-operatively, in the post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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:

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

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

  1. = To a slight degree
  2. = To a moderate degree
  3. = To a great degree
  4. = All the time with 0 being the lowest and 4 being the highest score.
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

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:

  1. = Not at all
  2. = A little bit
  3. = Somewhat
  4. = Quite a bit
  5. = Very much With 1 being the lowest and 5 being the highest
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
Self-reported measure of medication, dosage, and time of opioid consumption
Measured in the post-operative care unit (PACU), post-operative day (POD) 1, POD2, POD3, POD7
Severity 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, the severity of the nausea. Measured using the Opioid Related Symptom Distress Scale. If patients experienced nausea, the frequency, severity, and bothersomeness will be assessed.

Frequency will be assessed using a 4 point scale:

  1. rarely
  2. occasionally
  3. frequently
  4. almost constantly with 1 being the lowest and 4 being the highest.

Severity is assessed using a 4 point scale:

  1. slight
  2. moderate
  3. severe
  4. very severe with 1 being the lowest and 4 being the highest.

Bothersomeness is assessed using a 5 point scale:

  1. not at all
  2. a little bit
  3. somewhat
  4. quite a bit
  5. very much with 1 being the lowest and 5 being the highest.
Measured at post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7
Severity 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, the severity of the vomiting. Measured using the Opioid Related Symptom Distress Scale. If patients experienced vomiting, the number of episodes, severity, and bothersomeness will be assessed.

Severity is assessed using a 4 point scale:

  1. slight
  2. moderate
  3. severe
  4. very severe with 1 being the lowest and 4 being the highest.

Bothersomeness is assessed using a 5 point scale:

  1. not at all
  2. a little bit
  3. somewhat
  4. quite a bit
  5. very much with 1 being the lowest and 5 being the highest.
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 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
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:

  1. rarely
  2. occasionally
  3. frequently
  4. almost constantly with 1 being the lowest and 4 being the highest.

Severity is assessed using a 4 point scale:

  1. slight
  2. moderate
  3. severe
  4. very severe with 1 being the lowest and 4 being the highest.

Bothersomeness is assessed using a 5 point scale:

  1. not at all
  2. a little bit
  3. somewhat
  4. quite a bit
  5. very much with 1 being the lowest and 5 being the highest.
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

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:

  1. = Not satisfied
  2. = A little bit
  3. = Moderately
  4. = Quite a bit
  5. = Extremely satisfied with 1 being the lowest and 5 being the highest.
Measured at post operative day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital for Special Surgery, New York

Investigators

  • Principal Investigator: Uchenna Umeh, MD, Hospital for Special Surgery, New York

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2023

Primary Completion (Actual)

April 1, 2024

Study Completion (Actual)

April 1, 2024

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

September 13, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-1715

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make IPD available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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