NCT03069677

Music vs Midazolam During Preop Nerve Block Placement

Music vs Midazolam During Preoperative Nerve Block Placement: A Prospective, Randomized Controlled Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if there are differences in anxiety scores, heart rate, blood pressure, and oxygen status when using sedation medication versus music while undergoing a peripheral nerve block before your surgery.

Detailed description

The general flow of the study will be conducted as follows: 1. Research coordinator will call or approach patients who are scheduled for a surgical procedure that is planning for a peripheral nerve block either for the primary anesthetic or for postoperative pain control to be placed in the preoperative bay in the ambulatory surgical center. 2. Research coordinator will discuss the purpose of our study and explain the study in detail for the patient. If a patient agrees to participate, then we will have the patient sign the informed consent for the study. If patient is on the phone and decides to participate, the patient will sign the informed consent upon arriving to Penn Medicine University City (PMUC). 3. Once the patient signs the informed consent for the peripheral nerve block by anesthesia team. The patient randomized will be revealed to either music or IV midazolam. The pre-procedure anxiety score will then be obtained using the STAI-6 validated tool. 4. The golden moment will be conducted between the patient, provider, and nursing staff. Once this golden moment is completed, the anxiolytic intervention will start (music or IV midazolam)\* 5. The preoperative nerve block will be conducted by the regional anesthesia block team. 6. Once the nerve block is complete, we will obtain the post-procedure anxiety score using the STAI-6 validated tool. 7. Once the post-procedure anxiety score has been obtained, we will also obtain the patient satisfaction score, the provider satisfaction score, and the evaluation of any difficulties in communication between the provider and patient. After these questions have been obtained, the study is complete.

Conditions

• Anxiety
• Peripheral Nerve Block

Interventions

Type	Name	Description
OTHER	music	patients in this group will receive research-selected music after the golden moment has been completed between the patient, provider, and nursing staff
DRUG	Midazolam	patients in this group will receive IV midazolam (1mg to 2mg max) after the golden moment has been completed

Timeline

• Start date: 2017-04-12
• Primary completion: 2018-05-11
• Completion: 2018-05-11
• First posted: 2017-03-03
• Last updated: 2019-09-10
• Results posted: 2019-09-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study