Aromatherapy in Total Knee Replacement

Depression Clinical Trial

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

Status Completed

Clinical Trial 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 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 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, pain, opioid intake, and nausea/vomiting.

Clinical Trial 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:

• 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, pain, opioid intake, and vomiting. ;

Related Conditions & MeSH terms

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

• NCT number: NCT06045078
• Study type: Interventional
• Source: Hospital for Special Surgery, New York
• Status: Completed
• Phase: N/A
• Start date: October 3, 2023
• Completion date: April 1, 2024