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

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

Status
Terminated
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05610969
Enrollment
36
Registered
2022-11-09
Start date
2021-09-01
Completion date
2023-05-08
Last updated
2025-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Peripheral Nerve Block, Preoperative Anxiety

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

Brief summary

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

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.

Interventions

OTHERMusic

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

DRUGMidazolam

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

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

1:1

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

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 * 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.

Design outcomes

Primary

MeasureTime frameDescription
Change in STAI-6 Scores From Post to Pre1-2 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

MeasureTime frameDescription
Patient Satisfaction Scores of the Experience During Procedureimmediately 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
Provider Satisfaction Scores of the Experience During Procedureimmediately 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 Providerimmediately 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.
Block Times - Time it Took to do the Blockstart of doing the block to immediately after nerve block placement, less than 1 minute afterdifferences amongst music and midazolam group

Countries

United States

Participant flow

Participants by arm

ArmCount
Music Group
self-selected music Music: patients in this group will receive self-selected music after the golden moment has been completed between the patient, provider, and nursing staff
15
Midazolam Group
IV midazolam (1mg to 2mg max) Midazolam: patients in this group will receive IV midazolam (1mg to 2mg max) after the golden moment has been completed
21
Total36

Baseline characteristics

CharacteristicMidazolam GroupTotalMusic Group
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants1 Participants1 Participants
Age, Categorical
Between 18 and 65 years
21 Participants35 Participants14 Participants
Age, Continuous42 years
STANDARD_DEVIATION 18.1
42.3 years
STANDARD_DEVIATION 18.5
42.7 years
STANDARD_DEVIATION 19.1
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
5 Participants9 Participants4 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants0 Participants
Race (NIH/OMB)
White
15 Participants26 Participants11 Participants
Region of Enrollment
United States
21 participants36 participants15 participants
Sex: Female, Male
Female
7 Participants12 Participants5 Participants
Sex: Female, Male
Male
14 Participants24 Participants10 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 150 / 21
other
Total, other adverse events
0 / 150 / 21
serious
Total, serious adverse events
0 / 150 / 21

Outcome results

Primary

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.

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

Population: Due to lack of resources the study was terminated early and data collection is incomplete.

ArmMeasureGroupValue (MEAN)Dispersion
Music GroupChange in STAI-6 Scores From Post to PrePre STAI-634 score on a scaleStandard Deviation 7.02
Music GroupChange in STAI-6 Scores From Post to PrePost STAI-628.19 score on a scaleStandard Deviation 5.17
Midazolam GroupChange in STAI-6 Scores From Post to PrePre STAI-635.17 score on a scaleStandard Deviation 9.22
Midazolam GroupChange in STAI-6 Scores From Post to PrePost STAI-627.2 score on a scaleStandard Deviation 5
Secondary

Block Times - Time it Took to do the Block

differences amongst music and midazolam group

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

Population: Due to lack of resources the study was terminated early and data collection is incomplete.

ArmMeasureValue (MEAN)Dispersion
Music GroupBlock Times - Time it Took to do the Block7 minutesStandard Deviation 2.03
Midazolam GroupBlock Times - Time it Took to do the Block7.95 minutesStandard Deviation 3.26
Secondary

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.

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

Population: Due to lack of resources the study was terminated early and data collection is incomplete.

ArmMeasureGroupValue (MEDIAN)
Music GroupEvaluation of Difficulties in Communication From Provider to Patient and Patient to ProviderPatient Perspective1 score on a scale
Music GroupEvaluation of Difficulties in Communication From Provider to Patient and Patient to ProviderPhysician Perspective1 score on a scale
Midazolam GroupEvaluation of Difficulties in Communication From Provider to Patient and Patient to ProviderPatient Perspective1 score on a scale
Midazolam GroupEvaluation of Difficulties in Communication From Provider to Patient and Patient to ProviderPhysician Perspective1 score on a scale
Secondary

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

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

Population: Due to lack of resources the study was terminated early and data collection is incomplete.

ArmMeasureValue (MEDIAN)
Music GroupPatient Satisfaction Scores of the Experience During Procedure10 units on a scale
Midazolam GroupPatient Satisfaction Scores of the Experience During Procedure9 units on a scale
Secondary

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

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

Population: Due to lack of resources the study was terminated early and data collection is incomplete.

ArmMeasureValue (MEDIAN)
Music GroupProvider Satisfaction Scores of the Experience During Procedure10 units on a scale
Midazolam GroupProvider Satisfaction Scores of the Experience During Procedure10 units on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026