Anxiety Clinical Trial
Official title:
To Serenade or To Sedate? That is Still The Question - A Followup Trial On Anxiolytic Options Before Peripheral Nerve Blocks
This study is evaluating music vs midazolam as a means of anxiolysis for preoperative single-shot nerve block placement.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | September 30, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical 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) | |
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. | 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 | 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 | 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. | 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 | immediately after nerve block placement (less than 1 minute after) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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