Music vs Midazolam During Preop Nerve Block Placement

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-12

Study Completion Date

2018-05-11

Brief Summary

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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.

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Detailed Description

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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

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Anxiety Peripheral Nerve Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Music group

research-selected music

Group Type ACTIVE_COMPARATOR

music

Intervention Type OTHER

patients in this group will receive research-selected music after the golden moment has been completed between the patient, provider, and nursing staff

Midazolam group

IV midazolam (1mg to 2mg max)

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

patients in this group will receive IV midazolam (1mg to 2mg max) after the golden moment has been completed

Interventions

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music

patients in this group will receive research-selected music after the golden moment has been completed between the patient, provider, and nursing staff

Intervention Type OTHER

Midazolam

patients in this group will receive IV midazolam (1mg to 2mg max) after the golden moment has been completed

Intervention Type DRUG

Other Intervention Names

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Hypnovel

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No