Aromatherapy in Total Knee Replacement
Study Details
Study Description
Brief Summary
The purpose of this pilot randomized controlled study is to investigate the effects of aromatherapy on postoperative depression and anxiety 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:
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Intervention: Aromatherapy in the lavender-peppermint scent
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Control: Aromatherapy in 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 vomiting.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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:
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Short Form State Anxiety Inventory
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PROMIS Anxiety (short form 8a)
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PROMIS Depression (short form 8a)
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PROMIS Pain Interference (short form 6b)
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Catastrophizing Pain Scale
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Pain Rating Scale in Numeric Form
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Opioid Related Symptoms Distress Scale
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Questionnaire on Aromatherapy Satisfaction
Researchers will compare both groups (intervention vs control) to see if aromatherapy reduces post-operative anxiety, pain, opioid intake, and vomiting.
Study Design
Arms and Interventions
| 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 will be applied to the participants clothing 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 will be applied to the participants clothing 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
|
Outcome Measures
Primary Outcome Measures
- Difference in Anxiety level before and after surgery [Measured at pre-operative and post-operative day 7]
To assess the difference in pre-operative and post-operative anxiety. Measured using the PROMIS Anxiety short form 8a. Scored on the following scale: = Never = Rarely = Sometimes = Often = Always with 1 being the lowest score and 5 being the highest score.
- Changes in Anxiety level after surgery [measured at pre-operative, in the post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3]
To assess the cumulative change in participants' state anxiety level after surgery. Measured using the State Anxiety Inventory. Scored on the following scale: = not at all = somewhat = moderately = very much with 1 being the lowest score and 4 being the highest score.
- The average pain score after surgery [Measured at pre-operative, 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 Outcome Measures
- Difference in depression level before and after surgery [Measured at pre-operative, in the post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, 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.
- Average score on pain catastrophizing [Measured at pre-operative, in the post-anesthesia care unit (PACU), post-operative day (POD) 3, POD 7]
The PCS 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.
- Average score on pain interference [Measured at pre-operative, in the post-anesthesia care unit (PACU), post-operative day (POD) 3, 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
- Severity of post-operative nausea [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. Scored on a scale of 0-10, with 0 being the lowest and 10 being the highest.
- Severity of post-operative vomiting [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. Scored on a scale of 0-10, with 0 being the lowest and 10 being the highest.
- Incidences of post-operative complications [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 events.
- To assess the severity of opioid-related symptom distress [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 4-point 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. Scored on the following scale: = slight = moderate = severe = very severe with 1 being the lowest and 4 being the highest.
- To assess participants' satisfaction with the aromatherapy [Measured at post operative day 3]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age > 18 and ≤ 80
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Scheduled to undergo primary, unilateral knee replacement surgery
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Willing and able to provide informed consent
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Willing and able to complete follow-up procedures
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Intact olfactory function
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Score 19 or greater on the PROMIS Anxiety Shortform 8A
Exclusion Criteria:
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Score <19 on the PROMIS Emotional Distress - Anxiety - Short Form 8a
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History of major anxiety or depression
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currently taking medications to treat anxiety
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Impaired sense of smell
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History of chronic pain with opioid use for greater than 3 months History of Drug or Alcohol abuse
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History of fibromyalgia
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History of G6PD deficiency
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Plant or tree nut allergy
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Severe allergy to Opioids, NSAIDS or local anesthetics (such as anaphylaxis)
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Severe liver disease, renal insufficiency (with inability to take acetaminophen or NSAIDS)
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Non-English Speaking
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Surgery requiring a hospitalization of greater than 3 days
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Patient refusal
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Hx of cardiac fibrillation
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Chronic opioid user
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Hospital for Special Surgery, New York
Investigators
- Principal Investigator: Uchenna Umeh, MD, Hospital for Special Surgery, New York
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023-1715