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Behavioural Intervention

Aromatherapy for Postoperative Care in Knee Replacement

N/A

Recruiting

Led By Uchenna Umeh, MD

Research Sponsored by Hospital for Special Surgery, New York

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 18 and ≤ 80

Scheduled to undergo primary, unilateral knee replacement surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured pre-operatively, post-operative day (pod) 1, pod 2, pod 3, pod 7

Awards & highlights

Study Summary

This trial tests if aromatherapy may reduce post-op anxiety, pain, opioid use & nausea in total knee replacement patients.

Who is the study for?

This trial is for adults aged 18-80 scheduled for knee replacement surgery, who can consent and follow up, have a normal sense of smell, and experience anxiety. Excluded are those with severe allergies, liver or kidney issues, obesity (BMI ≥ 45), chronic pain or opioid use, certain heart conditions, nut allergies, or taking anxiety meds.Check my eligibility

What is being tested?

The study tests if Lavender-Peppermint Aromatherapy can reduce post-surgery anxiety, pain, opioid use and nausea/vomiting in knee replacement patients compared to an almond oil scent placebo. Participants will be randomly assigned to the aromatherapy or control group and complete questionnaires before and after surgery.See study design

What are the potential side effects?

Potential side effects may include allergic reactions due to sensitivity to the scents used in aromatherapy tabs. However, since this is not a drug intervention but rather an aromatic one using essential oils on tabs worn by patients; no significant systemic side effects are expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 19 and 80 years old.

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I am scheduled for knee replacement surgery on one knee.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured pre-operatively, post-operative day (pod) 1, pod 2, pod 3, pod 7

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured pre-operatively, post-operative day (pod) 1, pod 2, pod 3, pod 7

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured pre-operatively, post-operative day (pod) 1, pod 2, pod 3, pod 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in Anxiety level after surgery

The average pain score after surgery

Secondary outcome measures

Average post-operative opioid consumption

Average score on pain catastrophizing

Average score on pain interference

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Lavender-Peppermint Aromatherapy GroupExperimental Treatment1 Intervention

This is the interventional group. Participants in this group will receive aromatherapy tabs in the scent of lavender-peppermint. Tabs will be worn on a badge for a total of 72 hours, and participants will replace the aroma tabs every 12 hours.

Group II: Almond-oil Aromatherapy GroupPlacebo Group1 Intervention

This is the placebo group. Participants in this group will receive aromatherapy tabs in the scent of almond oil. Tabs will worn on a badge for a total of 72 hours, and participants will replace the aroma tabs every 12 hours.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hospital for Special Surgery, New YorkLead Sponsor

243 Previous Clinical Trials

59,334 Total Patients Enrolled

2 Trials studying Depression

69 Patients Enrolled for Depression

Uchenna Umeh, MDPrincipal InvestigatorHospital for Special Surgery, New York

4 Previous Clinical Trials

324 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the research extend to minors, or is it limited to adults?

"In order to be eligible for this clinical trial, the applicant must fall within the age range of 18-80."

Answered by AI

To what extent do applicants need to meet certain criteria in order to be enrolled in this medical experiment?

"Qualified participants in this experiment must have received a total knee arthroplasty and be between 18-80 years old. A maximum of 30 people will be accepted into the study."

Answered by AI

What is the current size of the participant pool for this clinical experiment?

"Affirmative, the data hosted on clinicaltrials.gov indicates that this study is still seeking patients to participate in its research. This trial was first published on October 3rd 2023 and has since been updated once more as of October 27th 2023. 30 participants are needed from 1 medical site."

Answered by AI

Are there any open enrolment opportunities for this trial?

"Affirmative, the information shared on clinicaltrials.gov states that this medical research is actively searching for participants. The initial post date was October 3rd 2023 and it has since been updated as of October 27th 2023. This trial necessitates 30 patients to be recruited from a single site."

Answered by AI

What are the main goals that this research endeavor is striving to accomplish?

"The primary assessment of this medical trial is the change in anxiety level before and after surgery. Secondary objectives include an evaluation of depression levels, average opioid consumption post-operatively, and symptom distress related to opioids. These will be measured pre-procedure, post anesthesia care unit (PACU), post operative day 1 (POD1), POD2, POD3, and on day 7 with various scales including PROMIS Depression Short Form 8a and Opioid Related Symptom Distress Scale (ORSDS)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Aromatherapy in Total Knee Replacement

2023. "Aromatherapy in Total Knee Replacement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06045078.

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