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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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I am older than 18 years.

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

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

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

Primary outcome measures

Opioid Consumption

Secondary outcome measures

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 / 2Eligibility criteria met

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Who is running the clinical trial?

Jacques E. ChellyLead Sponsor

8 Previous Clinical Trials

586 Total Patients Enrolled

Jacques E Chelly, MDPrincipal InvestigatorUniversity of Pittsburgh

5 Previous Clinical Trials

220 Total Patients Enrolled

Media Library

Auriculotherapy cryopuncture device with nitrogen gas (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04836936 — N/A

Anxiety Research Study Groups: Auriculotherapy cryopuncture device with nitrogen gas, Auriculotherapy cryopuncture device without nitrogen gas

Anxiety Clinical Trial 2023: Auriculotherapy cryopuncture device with nitrogen gas Highlights & Side Effects. Trial Name: NCT04836936 — N/A

Auriculotherapy cryopuncture device with nitrogen gas (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04836936 — N/A

Frequently Asked Questions

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

What is the participant capacity for this trial?

"Affirmative. Per information on ClinicalTrials.gov, this research study is actively recruiting patients; the trial was first published April 13th 2021 and has been revised February 14th 2022. The medical team needs to recruit a total of 60 participants from one location."

Answered by AI

Are there any available spots left for prospective participants in this investigative research?

"As per the information available on clinicaltrials.gov, this medical trial is seeking participants and has been accepting applications since April 13th 2021. The details of this study were last updated February 14th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Auriculotherapy in the Treatment of Pre-Operative Anxiety

Jacques E. Chelly 2021. "Auriculotherapy in the Treatment of Pre-Operative Anxiety". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04836936.