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OpenTrials
Completed

NCT Number: NCT03069677

Music vs Midazolam During Preop Nerve Block Placement

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

The general flow of the study will be conducted as follows:

  • 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.
  • 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).
  • 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.
  • 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)*
  • The preoperative nerve block will be conducted by the regional anesthesia block team.
  • Once the nerve block is complete, we will obtain the post-procedure anxiety score using the STAI-6 validated tool.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Music

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

Drug

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

Other names: Hypnovel

Primary outcomes

  1. Anxiety Levels

    Time frame: 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.

  2. Change in STAI-6 Scores From Post to Pre.

    Time frame: 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 outcomes

  1. Patient Satisfaction Scores of the Experience During Procedure

    Time frame: 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

  2. Provider Satisfaction Scores of the Experience During Procedure

    Time frame: 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

  3. Evaluation of Difficulties in Communication From Provider to Patient and Patient to Provider

    Time frame: 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.

  4. Block Times

    Time frame: immediately after nerve block placement (less than 1 minute after)

    differences amongst music and midaz group

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 3, 2017
Registry last updated
Sep 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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