A Phase 1/2 interventional study of Music and Midazolam in Peripheral Nerve Block, Anxiety and Preoperative Anxiety, sponsored by University of Pennsylvania. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-14.
Sponsored by University of Pennsylvania · Phase 1/2, Interventional, and Treatment
This study is evaluating music vs midazolam as a means of anxiolysis for preoperative single-shot nerve block placement.
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 36 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
self-selected music
Other: Music
IV midazolam (1mg to 2mg max)
Drug: Midazolam
patients in this group will receive self-selected music after the golden moment has been completed between the patient, provider, and nursing staff
patients in this group will receive IV midazolam (1mg to 2mg max) after the golden moment has been completed
Also known as: Hypnovel, Versed
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)
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)
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)
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)
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
| Milestone | Music Group | Midazolam Group |
|---|---|---|
| Started | 15 | 21 |
| Completed | 15 | 21 |
| Not completed | 0 | 0 |
Spielberger State-Trait Anxiety Inventory 6 Scale range is from 20 to 80. Higher the score, the higher the anxiety level is.
| score on a scale | Music Group | Midazolam Group |
|---|---|---|
| Pre STAI-6 | 34 ± 7.02 | 35.17 ± 9.22 |
| Post STAI-6 | 28.19 ± 5.17 | 27.2 ± 5.00 |
Survey which assess satisfaction on a 10-point numeric rating scale Scale ranges from 0 to 10. A higher number indicates a higher satisfaction
| units on a scale | Music Group | Midazolam Group |
|---|---|---|
| Patient Satisfaction Scores of the Experience During Procedure | 10 (8 to 10) | 9 (8 to 10) |
survey which assess satisfaction on a 10-point numeric rating scale Scale ranges from 0 to 10. A higher number indicates a higher satisfaction
| units on a scale | Music Group | Midazolam Group |
|---|---|---|
| Provider Satisfaction Scores of the Experience During Procedure | 10 (9 to 10) | 10 (8 to 10) |
surveyed on a 5-point Likert scale Scale ranges from 1 to 5; the higher the number, the more difficult it is to communicate.
| score on a scale | Music Group | Midazolam Group |
|---|---|---|
| Patient Perspective | 1 (1 to 2) | 1 (1 to 2) |
| Physician Perspective | 1 (1 to 2) | 1 (1 to 2) |
differences amongst music and midazolam group
| minutes | Music Group | Midazolam Group |
|---|---|---|
| Block Times - Time it Took to do the Block | 7 ± 2.03 | 7.95 ± 3.26 |
Collected over Adverse events were noted from the beginning of the block placement up to 30 minutes after end of block placement. Due to lack of resources the study was terminated early and data collection is incomplete.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Music Group | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Midazolam Group | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Age, Categorical(Participants) | Music Group | Midazolam Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 14 | 21 | 35 |
| >=65 years | 1 | 0 | 1 |
| Age, Continuous(years) | Music Group | Midazolam Group | Total |
|---|---|---|---|
| Mean | 42.7 ± 19.1 | 42 ± 18.1 | 42.3 ± 18.5 |
| Sex: Female, Male(Participants) | Music Group | Midazolam Group | Total |
|---|---|---|---|
| Female | 5 | 7 | 12 |
| Male | 10 | 14 | 24 |
| Race (NIH/OMB)(Participants) | Music Group | Midazolam Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 5 | 9 |
| White | 11 | 15 | 26 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(participants) | Music Group | Midazolam Group | Total |
|---|---|---|---|
| United States | 15 | 21 | 36 |
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University of Pennsylvania