Anxiety Clinical Trial
Official title:
Music vs Midazolam During Preoperative Nerve Block Placement: A Prospective, Randomized Controlled Study
NCT number | NCT03069677 |
Other study ID # | 826754 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | April 12, 2017 |
Est. completion date | May 11, 2018 |
Verified date | September 2019 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 160 |
Est. completion date | May 11, 2018 |
Est. primary completion date | May 11, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
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 | 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 | differences amongst music and midaz group | immediately after nerve block placement (less than 1 minute after) |
Status | Clinical Trial | Phase | |
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