Aromatherapy for Post-operative Anxiety and Pain After Primary Unilateral Total Knee Replacement: a Pilot Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Total Knee Replacement
- Sponsor
- Hospital for Special Surgery, New York
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Changes in Anxiety level before and each individual day after surgery.
- Status
- Completed
- Last Updated
- last year
Overview
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.
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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Changes in Anxiety level before and each individual day after surgery.
Time Frame: Measured pre-operatively, in the post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7
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.
Difference in anxiety level before and after surgery
Time Frame: Measured pre-operatively and on post-operative day (POD) 7
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.
The average pain score after surgery
Time Frame: Measured pre-operatively, in the post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7
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").
Secondary Outcomes
- 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)
- Presence of post-operative vomiting(Measured at post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7)
- Incidences of post-operative complications(Measured at post-anesthesia care unit (PACU) up to post operative day 7)
- To assess the severity of opioid-related symptom distress(Measured at post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7)
- To assess participants' satisfaction with the aromatherapy(Measured at post operative day 7)
- Aromatab Adherence(Measured on post operative day (POD) 1, POD2, POD3.)
- Hospital Length of Stay(Measured at discharge as number of hours elapsed between post anesthesia care unit entry and discharge time)
- Bang Blinding Index(Measured on postoperative day 7)