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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06045078
• Other study ID #: 2023-1715
• Status: Completed
• Phase: N/A
• Start date: October 3, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: April 2024
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

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

Intervention

Other:
• Elequil Lavender-peppermint Aromatabs
100% pure essential oils Lavender-peppermint aromatabs purchased through Beekley Medical
• Elequil Almond-Oil Aromatabs
100% pure essential oils Almond-oil aromatabs purchased through Beekley Medical

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

References & Publications (19)

Briggs P, Hawrylack H, Mooney R. Inhaled peppermint oil for postop nausea in patients undergoing cardiac surgery. Nursing. 2016 Jul;46(7):61-7. doi: 10.1097/01.NURSE.0000482882.38607.5c. — View Citation

Carey ET, Moore KJ, Young JC, Bhattacharya M, Schiff LD, Louie MY, Park J, Strassle PD. Association of Preoperative Depression and Anxiety With Long-term Opioid Use After Hysterectomy for Benign Indications. Obstet Gynecol. 2021 Nov 1;138(5):715-724. doi: — View Citation

Clover K, Lambert SD, Oldmeadow C, Britton B, Mitchell AJ, Carter G, King MT. Convergent and criterion validity of PROMIS anxiety measures relative to six legacy measures and a structured diagnostic interview for anxiety in cancer patients. J Patient Rep — View Citation

Franco L, Blanck TJ, Dugan K, Kline R, Shanmugam G, Galotti A, von Bergen Granell A, Wajda M. Both lavender fleur oil and unscented oil aromatherapy reduce preoperative anxiety in breast surgery patients: a randomized trial. J Clin Anesth. 2016 Sep;33:243 — View Citation

Hamzeh S, Safari-Faramani R, Khatony A. Effects of Aromatherapy with Lavender and Peppermint Essential Oils on the Sleep Quality of Cancer Patients: A Randomized Controlled Trial. Evid Based Complement Alternat Med. 2020 Mar 25;2020:7480204. doi: 10.1155/ — View Citation

Heidari Gorji MA, Ashrastaghi OG, Habibi V, Charati JY, Ebrahimzadeh MA, Ayasi M. The effectiveness of lavender essence on strernotomy related pain intensity after coronary artery bypass grafting. Adv Biomed Res. 2015 Jun 4;4:127. doi: 10.4103/2277-9175.1 — View Citation

Jones T, Purdy M, Stewart EA, Cutshall SM, Hathcock MA, Mahapatra S, Bauer BA, Ainsworth AJ. Lavender Aromatherapy to Reduce Anxiety During Intrauterine Insemination: A Randomized Controlled Trial. Glob Adv Health Med. 2021 Nov 17;10:21649561211059074. do — View Citation

Julian LJ. Measures of anxiety: State-Trait Anxiety Inventory (STAI), Beck Anxiety Inventory (BAI), and Hospital Anxiety and Depression Scale-Anxiety (HADS-A). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S467-72. doi: 10.1002/acr.20561. No ab — View Citation

Kim JT, Ren CJ, Fielding GA, Pitti A, Kasumi T, Wajda M, Lebovits A, Bekker A. Treatment with lavender aromatherapy in the post-anesthesia care unit reduces opioid requirements of morbidly obese patients undergoing laparoscopic adjustable gastric banding. — View Citation

Kim JT, Wajda M, Cuff G, Serota D, Schlame M, Axelrod DM, Guth AA, Bekker AY. Evaluation of aromatherapy in treating postoperative pain: pilot study. Pain Pract. 2006 Dec;6(4):273-7. doi: 10.1111/j.1533-2500.2006.00095.x. — View Citation

Koulivand PH, Khaleghi Ghadiri M, Gorji A. Lavender and the nervous system. Evid Based Complement Alternat Med. 2013;2013:681304. doi: 10.1155/2013/681304. Epub 2013 Mar 14. — View Citation

Lakhan SE, Sheafer H, Tepper D. The Effectiveness of Aromatherapy in Reducing Pain: A Systematic Review and Meta-Analysis. Pain Res Treat. 2016;2016:8158693. doi: 10.1155/2016/8158693. Epub 2016 Dec 14. — View Citation

Larach DB, Sahara MJ, As-Sanie S, Moser SE, Urquhart AG, Lin J, Hassett AL, Wakeford JA, Clauw DJ, Waljee JF, Brummett CM. Patient Factors Associated With Opioid Consumption in the Month Following Major Surgery. Ann Surg. 2021 Mar 1;273(3):507-515. doi: 1 — View Citation

Moeini M, Khadibi M, Bekhradi R, Mahmoudian SA, Nazari F. Effect of aromatherapy on the quality of sleep in ischemic heart disease patients hospitalized in intensive care units of heart hospitals of the Isfahan University of Medical Sciences. Iran J Nurs — View Citation

Mohr C, Jensen C, Padden N, Besel JM, Brant JM. Peppermint Essential Oil for Nausea and Vomiting in Hospitalized Patients: Incorporating Holistic Patient Decision Making Into the Research Design. J Holist Nurs. 2021 Jun;39(2):126-134. doi: 10.1177/0898010 — View Citation

Nasiri A, Mahmodi MA, Nobakht Z. Effect of aromatherapy massage with lavender essential oil on pain in patients with osteoarthritis of the knee: A randomized controlled clinical trial. Complement Ther Clin Pract. 2016 Nov;25:75-80. doi: 10.1016/j.ctcp.201 — View Citation

Pilkonis PA, Choi SW, Reise SP, Stover AM, Riley WT, Cella D; PROMIS Cooperative Group. Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS(R)): depression, anxiety, and anger. Assessment. — View Citation

Recklitis CJ, Blackmon JE, Chevalier LL, Chang G. Validating the Patient-Reported Outcomes Measurement Information System Short Form v1.0-Anxiety 8a in a sample of young adult cancer survivors: Comparison with a structured clinical diagnostic interview. C — View Citation

Soltani R, Soheilipour S, Hajhashemi V, Asghari G, Bagheri M, Molavi M. Evaluation of the effect of aromatherapy with lavender essential oil on post-tonsillectomy pain in pediatric patients: a randomized controlled trial. Int J Pediatr Otorhinolaryngol. 2 — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Anxiety level after surgery	To assess the cumulative change in participants' state anxiety level after surgery. Measured using the State Anxiety Inventory. Scored on the following scale: = not at all; = somewhat; = moderately so; = very much so; 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
Primary	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	Difference in depression level before and after surgery	To assess participants' post-operative emotional distress. Measured using the PROMIS depression short form 8a. Scored on the following scale: = never; = rarely; = sometimes; = often; = always with 1 being the lowest score and 5 being the highest scores.	Measured pre-operatively and on post-operative day (POD) 7
Secondary	Average score on pain catastrophizing	The Pain Catastrophizing Scale is made up of 13 phrases that describe various thoughts and sensations that people may have while they are in pain. The items are assessed on a 5-point scale and are grouped into three categories: rumination, magnification, and helplessness. Scored on the following scale: 0 = Not at all; = To a slight degree; = To a moderate degree; = To a great degree; = All the time with 0 being the lowest and 4 being the highest score.	Measured pre-operatively, post-operative day (POD) 1, POD 2, POD 3, POD 7
Secondary	Average score on pain interference	The PROMIS Pain Interference instruments (adult) measure the self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Pain Interference also incorporates items probing sleep and enjoyment in life, though the item bank only contains one sleep item. The Pain Interference items utilize a 7-day recall period (items include the phrase "the past 7 days"). Scored on the following scale: = Not at all; = A little bit; = Somewhat; = Quite a bit; = Very much With 1 being the lowest and 5 being the highest	Measured pre-operatively and on post-operative day (POD) 7
Secondary	Average post-operative opioid consumption	Self-reported measure of medication, dosage, and time of opioid consumption	Measured in the post-operative care unit (PACU), post-operative day (POD) 1, POD2, POD3, POD7
Secondary	Severity of post-operative nausea	To assess, if participants experience post-operative nausea, the severity of the nausea. Measured using the Opioid Related Symptom Distress Scale. If patients experienced nausea, the frequency, severity, and bothersomeness will be assessed.; Frequency will be assessed using a 4 point scale: rarely; occasionally; frequently; almost constantly with 1 being the lowest and 4 being the highest.; Severity is assessed using a 4 point scale: slight; moderate; severe; very severe with 1 being the lowest and 4 being the highest.; Bothersomeness is assessed using a 5 point scale: not at all; a little bit; somewhat; quite a bit; very much with 1 being the lowest and 5 being the highest.	Measured at post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7
Secondary	Severity of post-operative vomiting	To assess, if participants experience post-operative vomiting, the severity of the vomiting. Measured using the Opioid Related Symptom Distress Scale. If patients experienced vomiting, the number of episodes, severity, and bothersomeness will be assessed.; Severity is assessed using a 4 point scale: slight; moderate; severe; very severe with 1 being the lowest and 4 being the highest.; Bothersomeness is assessed using a 5 point scale: not at all; a little bit; somewhat; quite a bit; very much with 1 being the lowest and 5 being the highest.	Measured at post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7
Secondary	Incidences of post-operative complications	To assess the incidences of post-operative complications such as need for ICU admission, DVT/PE, MI, stroke.; To be measured in the number of patients who reported adverse events.	Measured at post-anesthesia care unit (PACU) up to post operative day 7
Secondary	To assess the severity of opioid-related symptom distress	The Opioid-Related Symptom Distress Scale (ORSDS) is a scale that assesses three dimensions of symptom distress (frequency, severity, and bothersomeness) for 12 symptoms. The symptom-specific ORSDS is calculated by taking the average of the three symptom distress dimensions.; Frequency will be assessed using a 4 point scale: rarely; occasionally; frequently; almost constantly with 1 being the lowest and 4 being the highest.; Severity is assessed using a 4 point scale: slight; moderate; severe; very severe with 1 being the lowest and 4 being the highest.; Bothersomeness is assessed using a 5 point scale: not at all; a little bit; somewhat; quite a bit; very much with 1 being the lowest and 5 being the highest.	Measured at post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7
Secondary	To assess participants' satisfaction with the aromatherapy	Self-reported responses on a survey of 7-items to assess participants' level of satisfaction with the aromatherapy they received.; Measured on the following scale: = Not satisfied; = A little bit; = Moderately; = Quite a bit; = Extremely satisfied with 1 being the lowest and 5 being the highest.	Measured at post operative day 7