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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music group | Active Comparator | research-selected music |
|
| Midazolam group | Active Comparator | IV midazolam (1mg to 2mg max) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| music | Other | patients in this group will receive research-selected music after the golden moment has been completed between the patient, provider, and nursing staff |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety Levels | Spielberger State-Trait Anxiety Inventory 6 Scale range is from 20 to 80. Higher the score, the higher the anxiety level is. | 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. | 1-2 minutes before conducting golden moment for nerve block placement and immediately after nerve block placement (less than 1 minute after) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | immediately after nerve block placement (less than 1 minute after) |
| Provider Satisfaction Scores of the Experience During Procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Veena Graff, MD, MS | University of Pennsylvania, Anesthesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31320504 | Derived | Graff V, Cai L, Badiola I, Elkassabany NM. Music versus midazolam during preoperative nerve block placements: a prospective randomized controlled study. Reg Anesth Pain Med. 2019 Jul 18:rapm-2018-100251. doi: 10.1136/rapm-2018-100251. Online ahead of print. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Music Group | research-selected music music: patients in this group will receive research-selected music after the golden moment has been completed between the patient, provider, and nursing staff |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
there was incomplete collection of data and patients dropped out which resulted in 77 total analyzed participants in this group
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| ID | Title | Description |
|---|---|---|
| BG000 | Music Group | research-selected music music: patients in this group will receive research-selected music after the golden moment has been completed between the patient, provider, and nursing staff |
| BG001 | Midazolam Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Anxiety Levels | Spielberger State-Trait Anxiety Inventory 6 Scale range is from 20 to 80. Higher the score, the higher the anxiety level is. | there was incomplete collection of data and patients dropped out which resulted in 77 total analyzed participants in this group | Posted | Median | Inter-Quartile Range | score on a scale | 1-2 minutes before conducting golden moment for nerve block placement and immediately after nerve block placement (less than 1 minute after) |
|
one year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Music Group | research-selected music music: patients in this group will receive research-selected music after the golden moment has been completed between the patient, provider, and nursing staff there was incomplete collection of data and patients dropped out which resulted in 77 total analyzed participants in this group |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Veena Graff MD, MS | University of Pennsylvania | (215) 662-8244 | veena.graff@uphs.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 18, 2017 | Jun 13, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009147 | Music Therapy |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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1:1
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| Midazolam | Drug | patients in this group will receive IV midazolam (1mg to 2mg max) after the golden moment has been completed |
|
|
survey which assess satisfaction on a 10-point numeric rating scale Scale ranges from 0 to 10. A higher number indicates a higher satisfaction |
| 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. | immediately after nerve block placement (less than 1 minute after) |
| Block Times | differences amongst music and midaz group | immediately after nerve block placement (less than 1 minute after) |
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
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
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 |
|
|
| 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. | there was incomplete collection of data and patients dropped out which resulted in 77 total analyzed participants in this group | Posted | Mean | Standard Deviation | score on a scale | 1-2 minutes before conducting golden moment for nerve block placement and immediately after nerve block placement (less than 1 minute after) |
|
|
|
| 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 | there was incomplete collection of data and patients dropped out which resulted in 77 total analyzed participants in this group | Posted | Median | Inter-Quartile Range | units on a scale | immediately after nerve block placement (less than 1 minute after) |
|
|
|
| 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 | there was incomplete collection of data and patients dropped out which resulted in 77 total analyzed participants in this group | Posted | Median | Inter-Quartile Range | units on a scale | immediately after nerve block placement (less than 1 minute after) |
|
|
|
| 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. | there was incomplete collection of data and patients dropped out which resulted in 77 total analyzed participants in this group | Posted | Median | Inter-Quartile Range | score on a scale | immediately after nerve block placement (less than 1 minute after) |
|
|
|
| Secondary | Block Times | differences amongst music and midaz group | there was incomplete collection of data and patients dropped out which resulted in 77 total analyzed participants in this group | Posted | Mean | Standard Deviation | minutes | immediately after nerve block placement (less than 1 minute after) |
|
|
|
| 0 |
| 77 |
| 0 |
| 77 |
| 0 |
| 77 |
| EG001 | 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 | 0 | 80 | 0 | 80 | 0 | 80 |
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| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |