← Back to Search

Behavioural Intervention

Auriculotherapy for Pre-Operative Anxiety

N/A

Recruiting

Led By Jacques E Chelly, MD

Research Sponsored by Jacques E. Chelly

Eligibility Criteria Checklist

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

Must have

Greater than 18 years of age

Scheduled to undergo partial or full elective nephrectomy

Must not have

History of fibromyalgia

Anatomical malformation of ear (genetic or trauma-induced)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day of surgery through discharge or post-operative day 30, whichever came first

Summary

This trial will use two validated questionnaires to measure anxiety and depression before and after surgery, in order to establish a correlation between the auriculotherapy treatment and the reduction of perioperative anxiety. The subject population will include those having a partial or total nephrectomy for cancer. This trial will also examine the effect of the auriculotherapy intervention in reducing opioid requirement after surgery.

Who is the study for?

This trial is for adults over 18 who are feeling anxious (with specific anxiety scores) and are about to have kidney cancer surgery. They must understand and agree to the study's process. People with fibromyalgia, ear problems, poor blood flow in the ears, Raynaud's disease, opioid addiction or those needing daily opioids for chronic pain can't join.

What is being tested?

The study tests auriculotherapy—a type of acupuncture using cold temperatures—to see if it reduces anxiety before surgery. Participants will receive this therapy with or without nitrogen gas and their anxiety levels will be measured before and after treatment.

What are the potential side effects?

Potential side effects may include discomfort at the ear site where treatment is applied due to cold exposure from cryopuncture devices used during auriculotherapy.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am older than 18 years.

Select...

I am scheduled for a surgery to remove part or all of my kidney.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with fibromyalgia.

Select...

I have an ear shape issue due to genetics or injury.

Select...

I need opioids daily for chronic pain.

Select...

I have chosen not to participate in certain treatments.

Select...

I have Raynaud's disease.

Select...

I have blood vessel problems in my ear.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day of surgery through discharge or post-operative day 30, whichever came first

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day of surgery through discharge or post-operative day 30, whichever came first

This trial's timeline: 3 weeks for screening, Varies for treatment, and day of surgery through discharge or post-operative day 30, whichever came first for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Opioid Consumption

Secondary study objectives

Functional Recovery

Overall patient satisfaction

Post-operative analgesic utilization

+7 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Auriculotherapy cryopuncture device with nitrogen gasActive Control1 Intervention

Auriculotherapy will be performed in the pre-operative setting by PI or trained designee using a cryopuncture device with nitrogen gas. The patient will otherwise receive standard of care treatment for surgery and post-operative pain management.

Group II: Auriculotherapy cryopuncture device without nitrogen gasPlacebo Group1 Intervention

Auriculotherapy will be performed in the pre-operative setting by PI or trained designee using an empty cryopuncture device without nitrogen gas. The patient will otherwise receive standard of care treatment for surgery and post-operative pain management.

0 / 8Eligibility criteria met