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Peripheral Nerve BlockPhase 1/2NCT05610969

Music vs Midazolam During Preop Nerve Block Placement - Part 2 Study On Anxiolytic Options Before Peripheral Nerve Blocks

A Phase 1/2 study testing Music and Midazolam in people with Peripheral Nerve Block and Anxiety, run by University of Pennsylvania at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is evaluating music vs midazolam as a means of anxiolysis for preoperative single-shot nerve block placement. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Music and Midazolam
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
1 Sep 2021to 8 May 2023
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
  • history of renal impairment.
  • Patients who were extremely anxious (scores greater than 50 on the State Trait Anxiety Inventory-6 (STAI-6) tool) were also excluded from the study.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: To Serenade or To Sedate? That is Still The Question - A Followup Trial On Anxiolytic Options Before Peripheral Nerve Blocks

This study is evaluating music vs midazolam as a means of anxiolysis for preoperative single-shot nerve block placement.

Read the detailed description

Preoperative anxiety is common and can adversely affect a patient's perioperative course by elevating stress markers, promoting fluctuations in hemodynamics and negatively impacting on postoperative recovery. Preoperative anxiety is routinely treated with pharmacologic agents such as midazolam, a benzodiazepine, which has known, undesirable side effects including respiratory depression, hemodynamic perturbations, and paradoxical effects such as hostility, aggression, and psychomotor agitation. The use of sedative medications requires continuous vital sign monitoring of patients by either anesthesia or nursing personnel and there is a question of whether midazolam helps reduce pre-procedural anxiety compared with placebo. Music is a non-pharmacologic intervention that has been shown to significantly decrease preoperative anxiety. This intervention can be used as an adjunct or even replace pharmacologic agents to help with preoperative anxiety. Music is a modality that is virtually harm-free and relatively cheap in cost. Patients who are unable to tolerate pharmacologic agents to treat preoperative anxiety can greatly benefit from non-pharmacologic options such as music.

Regional anesthesia procedures such as an ultrasound guided, peripheral nerve block is a common bedside procedure done preoperatively. Patients may have some anxiety prior to the administration of this nerve block procedure and may receive sedation for it. However, it is imperative not to over sedate them as constant feedback from the patient is necessary during the procedure. Commonly, midazolam is used to reduce this anxiety, but non-pharmacologic therapies can also reduce anxiety. In our recent published study, we evaluated the use of research-selected, relaxing music, to reduce anxiety before the nerve block is administered. In this study, we used noise-canceling headphones and played research-selected music as our anxiolytic music modality and compared this with midazolam. The findings showed no difference between both groups in the change in anxiety scores from after to before the nerve block, however patients had better satisfaction in the midazolam group and increased difficulty in communication in the music group. We attributed this to not allowing patients to choose their own selection of music and the use of noise-canceling headphones.

Therefore, in this follow-up study, we aim to evaluate the use of patient-selected music via non-noise canceling headphones as a preoperative anxiolytic prior to the administration of a bedside, peripheral nerve block procedure. This study will be conducted at an ambulatory surgical center in a university setting.

Being tested
Music, Midazolam
Keywords
Midazolam, Adjuvants, Anesthesia, Anti-Anxiety Agents, Hypnotics and Sedatives, Tranquilizing Agents, Anesthetics, GABA Modulators, GABA Agents, Central Nervous System Depressants, Physiological Effects of Drugs, Neurotransmitter Agents
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MusicOther

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

  • MidazolamDrug

    Also called Hypnovel, Versed

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

Study groups in NCT05610969
Study groupRoleWhat they receive
Music groupActive comparatorself-selected music
Receives: Other: Music
Midazolam groupActive comparatorIV midazolam (1mg to 2mg max)
Receives: Drug: Midazolam

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Spielberger State-Trait Anxiety Inventory 6 Scale range is from 20 to 80. Higher the score, the higher the anxiety level is.

    Measured: 1-2 minutes before conducting golden moment for nerve block placement and immediately after nerve block placement (less than 1 minute after)

Secondary outcomes (4)
  1. Patient Satisfaction Scores of the Experience During Procedure

    Survey which assess satisfaction on a 10-point numeric rating scale Scale ranges from 0 to 10. A higher number indicates a higher satisfaction

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

  2. Provider Satisfaction Scores of the Experience During Procedure

    survey which assess satisfaction on a 10-point numeric rating scale Scale ranges from 0 to 10. A higher number indicates a higher satisfaction

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

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

    surveyed on a 5-point Likert scale Scale ranges from 1 to 5; the higher the number, the more difficult it is to communicate.

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

  4. Block Times - Time it Took to do the Block

    differences amongst music and midazolam group

    Measured: start of doing the block to immediately after nerve block placement, less than 1 minute after

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2022
  2. Study start1 Sep 2021
  3. Primary completion8 May 2023
  4. Study completion8 May 2023

Why it stopped: terminated due to lack of resources

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1:1
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05610969
Sponsor's protocol ID
842519
Status last verified
May 2025
First submitted
5 Aug 2022
Last updated
14 May 2025
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Music and Midazolam in people with Peripheral Nerve Block and Anxiety, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.

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