CompletedNot Applicable

Aromatherapy in Total Knee Replacement

United States30 participantsStarted 2023-10-03

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 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

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

The average pain score after surgery

Timeframe: Measured pre-operatively, in the post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7

Trial details

NCT IDNCT06045078

SponsorHospital for Special Surgery, New York

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-01

View on ClinicalTrials.gov More Total Knee Replacement trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 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

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

The average pain score after surgery

Timeframe: Measured pre-operatively, in the post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7