Aromatherapy in Total Knee Replacement

Hospital for Special Surgery (HSS)

Status: Completed

Conditions: Post-operative Nausea and Vomiting; Opioid Use; Depression; Anxiety; Post Operative Pain; Total Knee Replacement

Treatments: Other: Elequil Lavender-peppermint Aromatabs; Other: Elequil Almond-Oil Aromatabs

Study type: Interventional

Funder types: Other

Identifiers

NCT06045078

2023-1715

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Lavender-Peppermint Aromatherapy Group

Experimental group

Description:

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.

Treatment:

Other: Elequil Lavender-peppermint Aromatabs

Almond-oil Aromatherapy Group

Placebo Comparator group

Description:

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.

Treatment:

Other: Elequil Almond-Oil Aromatabs