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terminated due to lack of resources
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music group | Active Comparator | self-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 self-selected music after the golden moment has been completed between the patient, provider, and nursing staff |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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, Anesthesiology and Critical Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| 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 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| 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 | 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. | Due to lack of resources the study was terminated early and data collection is incomplete. | 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) |
|
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.
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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 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Veena Graff MD, MS | University of Pennsylvania | (215) 662-8244 | veena.graff@pennmedicine.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 | Jan 31, 2020 | Feb 26, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 31, 2019 | Feb 26, 2025 | ICF_001.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 - Time it Took to do the Block | differences amongst music and midazolam group | start of doing the block to 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 (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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
|
|
| 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 | Due to lack of resources the study was terminated early and data collection is incomplete. | 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 | Due to lack of resources the study was terminated early and data collection is incomplete. | 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. | Due to lack of resources the study was terminated early and data collection is incomplete. | Posted | Median | Inter-Quartile Range | score on a scale | immediately after nerve block placement (less than 1 minute after) |
|
|
|
| Secondary | Block Times - Time it Took to do the Block | differences amongst music and midazolam group | Due to lack of resources the study was terminated early and data collection is incomplete. | Posted | Mean | Standard Deviation | minutes | start of doing the block to immediately after nerve block placement, less than 1 minute after |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| 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 | 21 | 0 | 21 | 0 | 21 |
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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 |
| Physician Perspective |
|
|