Aromatherapy in Total Knee Replacement

NCT06045078 | Completed

• 1 other identifier: 2023-1715
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Changes in Anxiety level before and each individual day after surgery.

  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: 1. = not at all 2. = somewhat 3. = moderately so 4. = very much so Trait anxiety was scored on the following scale: 1. almost never 2. sometimes 3. often 4. almost always 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

• Difference in anxiety level before and after surgery

  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: 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

• The average pain score after surgery

  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 Outcomes (12)

• Difference in depression level before and after surgery

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

• Average score on pain catastrophizing

  Measured pre-operatively, post-operative day (POD) 1, POD 2, POD 3, POD 7

• Average score on pain interference

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

• Average post-operative opioid consumption

  Measured in the post-operative care unit (PACU), post-operative day (POD) 1, POD2, POD3, POD7

• Presence of post-operative nausea

  Measured at post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7

Study Arms (2)

Lavender-Peppermint Aromatherapy Group

EXPERIMENTAL

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

Almond-oil Aromatherapy Group

PLACEBO COMPARATOR

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

Interventions

Elequil Lavender-peppermint Aromatabs OTHER

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

Lavender-Peppermint Aromatherapy Group

Elequil Almond-Oil Aromatabs OTHER

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

Almond-oil Aromatherapy Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

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MeSH Terms

Conditions

Vomiting; Anxiety Disorders; Depression; Pain, Postoperative

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations

Study Officials

• Uchenna Umeh, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Research staff (i.e. research assistants, coordinators, etc.)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A pilot randomized controlled trial

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 21, 2023
• Study Start: October 3, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)