Auriculotherapy in the Treatment of Pre-Operative Anxiety - A Randomized, Prospective, Placebo-Controlled Clinical Trial

Brief Summary

Detailed Description

Sixty subjects undergoing total or partial nephrectomies will be asked to participate in this IRB approved placebo-controlled randomized study. Potential subjects will be recruited out of the surgeon's office or at a preoperative clinical visit prior to surgery. The clinical care team will introduce the study and request permission for the research team to speak with the patient. If the subject agrees to be approached by a member of the research team, then the research team will approach the subject. During the Informed Consent, a PI or Co-I will be available to answer final questions and facilitate the process. After signing an informed consent, the subjects will be equally randomized to either active auriculotherapy treatment (with nitrogen gas) or placebo auriculotherapy treatment (without nitrogen gas). Each subject will be asked to complete the PROMIS Emotional Distress - Anxiety - Short Form 8a, the PROMIS Emotional Distress-Depression-Short Form and Pain Catastrophizing Scale (PCS) in the pre-operative setting. Those whose anxiety scores are ≥19 and ≤29 will be included in the study and randomly distributed to either treatment allocation. Randomization will occur by assigning the participant a subject ID number, and this ID number will correspond to a treatment allocation based on a pre-designed randomization schema. This treatment allocation (intervention/control) will be contained in a sealed, opaque, envelope with the subject ID number that is designated on envelope. The master randomization list will be created and held by an independent data monitor who will both create and hold the master randomization list. A data manager research associate will confidentially reveal the randomization to the PI or Amy Monroe so that the study coordinators, Co-Is and subjects will be blinded. PI or Amy Monroe, and the data managing associate will be the only individuals who are unblinded. Study assessments will be conducted on the day of surgery, in the pre-operative setting. This will include the PROMIS Emotional Distress - Anxiety - Short Form 8a as this is the first assessment conducted after obtaining Informed Consent. It is used to assess eligibility for the study. This assessment will take roughly 5 minutes. Auriculotherapy treatment will also occur in the pre-operative setting, within one hour of surgery and after the patient has received a peripheral nerve block. For the active treatment group, a nitrogen gas canister will be applied to a cryopuncture device (manual attached), and the tip of the cryopuncture will be sanitized and placed on each treatment point of the ear, releasing a spurt of gas for 2 seconds on each point (7 points total). For the sham device, an empty canister will be applied to the cryopuncture device, and in exactly the same fashion as the treatment group, the tip of the cryopuncture will be sanitized and placed on each treatment point of the ear. Instead of releasing a spurt of nitrogen gas, the empty canister will make the same noise as a full canister, but without the expulsion of gas. We are not expecting any adverse events from performing this technique. The only "adverse event" that is expected is a mild local blistering/scab, which may occur within 24 hours after the treatment. In our experience in our ongoing auriculotherapy study (24 subjects enrolled), we did not observe this adverse event. In the experience of Dr. Chelly(11 years) and Dr. Alimi (30 years), any local blistering or ulceration is extremely mild, and resolves in days without any intervention. No potential adverse effect would require immediate treatment or delay the surgery. After surgery, the subject will be assessed for pain medication requirement and pain scores in the post-anesthesia care unit (PACU) and then assessed daily until discharge. Upon discharge, subjects will repeat the PROMIS Emotional Distress questionnaires and the PCS. Additionally, subjects will be asked to complete an overall satisfaction questionnaire measured on a scale to 0-10. The subjects will take home a diary where they will record daily NRS pain scores (scale 0-10), daily anxiety level (scale 0-10) and daily analgesic/opioid requirement for one-week post-op. The subject will be contacted daily after discharge until completion of the pain diary at Day 7 post-op, and will also be contacted once at 30-day and 90-day post-op to report the PROMIS Emotional Distress -Anxiety- Short Form 8a, the PROMIS Emotional Distress-Depression-Short Form, and Pain Catastrophizing Scale (PCS) verbally over the telephone. The subject will be contacted via phone daily to gather their responses post op to the surveys, a maximum of three times. If we are unable to reach the subject after 3 days they will be considered lost to follow up. If In addition to this, the subject will be asked to assess their functional recovery using the SF-12 questionnaire, and to report their VAS pain score/opioid consumption for the previous week.

Primary Outcomes

Secondary Outcomes

• Pre-operative emotional distress related to anxiety(Screening visit)
• Post-operative analgesic utilization(Day of surgery through 3 months post-operative)
• Post-operative pain rating using the Visual Analog Scale (VAS)(Day of surgery through 3 months post-operative)
• Post-operative pain rating using the Pain Catastrophizing Scale(Day of surgery through 3 months post-operative)
• Functional Recovery(Day of surgery through 3 months post-operative)
• Overall patient satisfaction(Day of surgery through discharge or post-operative day 30, whichever came first)
• Post-operative emotional distress related to anxiety(Day of surgery through 3 months post-operative)
• Pre-operative emotional distress related to depression(Screening visit)
• Post-operative emotional distress related to depression(Day of surgery through 3 months post-operative)
• Pre-operative pain rating using the Pain Catastrophizing Scale(Screening visit)