Using auriculotherapy to reduce anxiety before kidney surgery
Auriculotherapy in the Treatment of Pre-Operative Anxiety - A Randomized, Prospective, Placebo-Controlled Clinical Trial
This study is testing if auriculotherapy can help reduce anxiety in patients having kidney surgery and see if it can also lower their need for pain medication afterward.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT04836936 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of auriculotherapy in reducing pre-operative anxiety in patients scheduled for partial or total nephrectomy due to cancer. Sixty participants will be randomly assigned to receive either active auriculotherapy with nitrogen gas or a placebo treatment without nitrogen gas. The study will utilize validated anxiety and depression assessment tools to measure changes in emotional distress before and after the intervention. Additionally, it will explore the potential of auriculotherapy to decrease opioid requirements post-surgery, addressing a significant risk factor for opioid use disorders in surgical patients.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 scheduled for elective partial or full nephrectomy with moderate anxiety levels.
Not a fit: Patients with opioid dependence, chronic pain conditions requiring daily opioid use, or specific ear anatomical issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pre-operative anxiety and opioid use in patients undergoing kidney surgery.
How similar studies have performed: While the use of auriculotherapy is gaining interest, this specific application in pre-operative anxiety management is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Greater than 18 years of age * Scheduled to undergo partial or full elective nephrectomy * Subject is willing and able to provide informed consent * Anxiety score ≥ 19 and ≤ 29 on the PROMIS Emotional Distress-Anxiety-Short Form 8a. Exclusion Criteria: * Opioid dependence, based on the DSM definition of Opioid Use Disorder (OUD) * Chronic pain condition where daily opioid use is needed * History of fibromyalgia * Anatomical malformation of ear (genetic or trauma-induced) * Vasculopathy of ear * Raynaud's disease * Patient Refusal
Where this trial is running
Pittsburgh, Pennsylvania
- UPMC Shadyside Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Jacques E Chelly, MD — University of Pittsburgh
- Study coordinator: Amy Monroe
- Email: monroeal@upmc.edu
- Phone: 412-623-6382
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.