Phase 3
N=160
Music vs Midazolam During Preop Nerve Block Placement
Anxiety · Peripheral Nerve Block
Bottom Line
View on ClinicalTrials.gov: NCT03069677 ↗Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Anxiety Levels — 33.3; 30; 30; 23.3 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- music (Other); Midazolam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anxiety Levels |
33.3; 30; 30; 23.3 | — |
| PRIMARY Change in STAI-6 Scores From Post to Pre. |
-1.6; -4.2 | — |
| SECONDARY Patient Satisfaction Scores of the Experience During Procedure |
8; 9 | — |
| SECONDARY Provider Satisfaction Scores of the Experience During Procedure |
9; 10 | — |
| SECONDARY Evaluation of Difficulties in Communication From Provider to Patient and Patient to Provider |
1; 1; 1; 1 | — |
| SECONDARY Block Times |
6.7; 7 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients who are >18 years of age, who will 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; and history of renal impairment. Patients who were extremely anxious (scores 50 and greater on the State Trait Anxiety Inventory-6 (STAI-6) tool) were also excluded from the study.
Data sourced from ClinicalTrials.gov (NCT03069677). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.