NCT06045078

Aromatherapy in Total Knee Replacement

Aromatherapy for Post-operative Anxiety and Pain After Primary Unilateral Total Knee Replacement: A Pilot Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Hospital for Special Surgery, New York · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Elequil Lavender-peppermint Aromatabs	100% pure essential oils Lavender-peppermint aromatabs purchased through Beekley Medical
OTHER	Elequil Almond-Oil Aromatabs	100% pure essential oils Almond-oil aromatabs purchased through Beekley Medical

Timeline

• Start date: 2023-10-03
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2023-09-21
• Last updated: 2025-01-27

Locations

1 site across 1 country: United States