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Music vs Midazolam During Preop Nerve Block Placement

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ClinicalTrials.gov Identifier: NCT03069677
Recruitment Status : Completed
First Posted : March 3, 2017
Results First Posted : September 10, 2019
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Anxiety Peripheral Nerve Block Other: music Drug: Midazolam Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Music vs Midazolam During Preoperative Nerve Block Placement: A Prospective, Randomized Controlled Study
Actual Study Start Date : April 12, 2017
Actual Primary Completion Date : May 11, 2018
Actual Study Completion Date : May 11, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Active Comparator: Music group
research-selected music
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

Active Comparator: Midazolam group
IV midazolam (1mg to 2mg max)
Drug: Midazolam
patients in this group will receive IV midazolam (1mg to 2mg max) after the golden moment has been completed
Other Name: Hypnovel




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03069677


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Veena Graff, MD, MS University of Pennsylvania, Anesthesia
  Study Documents (Full-Text)

Documents provided by University of Pennsylvania:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03069677     History of Changes
Other Study ID Numbers: 826754
First Posted: March 3, 2017    Key Record Dates
Results First Posted: September 10, 2019
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Pennsylvania:
midazolam
Additional relevant MeSH terms:
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Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action