A Phase 3 interventional study of music and Midazolam in Anxiety and Peripheral Nerve Block, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-10.
Sponsored by University of Pennsylvania · Phase 3, Interventional, and Treatment
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.
The general flow of the study will be conducted as follows:
5,063 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.
This study's enrollment of 160 is above the median of 80 across 4,339 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →University of Pennsylvania is the lead sponsor of 1,664 studies on the registry; 236 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 107 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
research-selected music
Other: music
IV midazolam (1mg to 2mg max)
Drug: Midazolam
patients in this group will receive research-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
Anxiety Levels
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)
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
differences amongst music and midaz group
Time frame: immediately after nerve block placement (less than 1 minute after)
| Milestone | Music Group | Midazolam Group |
|---|---|---|
| Started | 80 | 80 |
| Completed | 77 | 77 |
| Not completed | 3 | 3 |
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 Scores | 33.3 (23.3 to 41.7) | 30 (20 to 40) |
| Post-STAI-6 Scores | 30 (20 to 40) | 23.3 (20 to 33.3) |
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 |
|---|---|---|
| Change in STAI-6 Scores From Post to Pre. | -1.6 ± 10.7 | -4.2 ± 11 |
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 | 8 (5 to 9) | 9 (7 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 | 9 (8 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 on Communication | 1 (1 to 2) | 1 (1 to 1) |
| Physician Perspective on Communication | 1 (1 to 2) | 1 (1 to 1) |
differences amongst music and midaz group
| minutes | Music Group | Midazolam Group |
|---|---|---|
| Block Times | 6.7 ± 4.2 | 7 ± 4.2 |
Collected over one year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Music Group | 0/77 (0%) | 0/77 (0%) | 0/77 (0%) |
| Midazolam Group | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) |
there was incomplete collection of data and patients dropped out which resulted in 77 total analyzed participants in this group
| Age, Categorical(Participants) | Music Group | Midazolam Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 77 | 80 | 157 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Music Group | Midazolam Group | Total |
|---|---|---|---|
| Mean | 45 ± 15.6 | 46 ± 16 | 45.5 ± 15.8 |
| Sex: Female, Male(Participants) | Music Group | Midazolam Group | Total |
|---|---|---|---|
| Female | 52 | 50 | 102 |
| Male | 25 | 30 | 55 |
| Race/Ethnicity, Customized(Participants) | Music Group | Midazolam Group | Total |
|---|---|---|---|
| Race — White | 52 | 50 | 102 |
| Race — Black | 21 | 23 | 44 |
| Race — Asian | 4 | 5 | 9 |
| Race — Other | 0 | 2 | 2 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Apr 2017 to primary completion in May 2018, 12 months.
Results were first posted in Sep 2019, 1 year 3 months after primary completion.
Of 31 phase 3 interventional studies under Anxiety Disorders, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 24. This study's 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Midazolam