Music vs Midazolam During Preop Nerve Block Placement

Phase 3

Completed

• Conditions: Anxiety; Peripheral Nerve Block
• Interventions: Other: music; Drug: Midazolam

• Registration Number: NCT03069677
• Lead Sponsor: University of Pennsylvania

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-02-22
• Study First Submitted QC: 2017-02-27
• Study First Posted: 2017-03-03
• Study Start: 2017-04-12
• Primary Completion: 2018-05-11
• Study Completion: 2018-05-11
• Results First Submitted: 2019-06-17
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-09
• Last Update Submitted: 2019-09-09
• Results First Posted: 2019-09-10
• Last Update Posted: 2019-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Patients who are >18 years of age, who will give informed consent in receiving a peripheral nerve block in the preoperative bay for their primary anesthetic and/or for their postoperative pain control.

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Exclusion Criteria

• significant psychiatric disorder such as generalized anxiety disorder, panic disorder, depression, psychosis, bipolar disorder; individuals who were incompetent to give informed consent; pregnant and/or breast feeding patients; any underlying coagulopathy, infection or other factors which would be a contraindication to receiving a peripheral nerve block; hypersensitivity to midazolam; and history of renal impairment. Patients who were extremely anxious (scores 50 and greater on the State Trait Anxiety Inventory-6 (STAI-6) tool) were also excluded from the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music group	music	research-selected music
Midazolam group	Midazolam	IV midazolam (1mg to 2mg max)

Primary Outcome Measures

Name	Time	Method
Anxiety Levels	1-2 minutes before conducting golden moment for nerve block placement and immediately after nerve block placement (less than 1 minute after)	Spielberger State-Trait Anxiety Inventory 6; Scale range is from 20 to 80. Higher the score, the higher the anxiety level is.
Change in STAI-6 Scores From Post to Pre.	1-2 minutes before conducting golden moment for nerve block placement and immediately after nerve block placement (less than 1 minute after)	Spielberger State-Trait Anxiety Inventory 6; Scale range is from 20 to 80. Higher the score, the higher the anxiety level is.

Secondary Outcome Measures

Name	Time	Method
Provider Satisfaction Scores of the Experience During Procedure	immediately after nerve block placement (less than 1 minute after)	survey which assess satisfaction on a 10-point numeric rating scale; Scale ranges from 0 to 10. A higher number indicates a higher satisfaction
Block Times	immediately after nerve block placement (less than 1 minute after)	differences amongst music and midaz group
Patient Satisfaction Scores of the Experience During Procedure	immediately after nerve block placement (less than 1 minute after)	survey which assess satisfaction on a 10-point numeric rating scale; Scale ranges from 0 to 10. A higher number indicates a higher satisfaction
Evaluation of Difficulties in Communication From Provider to Patient and Patient to Provider	immediately after nerve block placement (less than 1 minute after)	surveyed on a 5-point Likert scale; Scale ranges from 1 to 5; the higher the number, the more difficult it is to communicate.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States