Trial Outcomes & Findings for Music vs Midazolam During Preop Nerve Block Placement - Part 2 Study On Anxiolytic Options Before Peripheral Nerve Blocks (NCT NCT05610969)
NCT ID: NCT05610969
Last Updated: 2025-05-14
Results Overview
Spielberger State-Trait Anxiety Inventory 6 Scale range is from 20 to 80. Higher the score, the higher the anxiety level is.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
36 participants
Primary outcome timeframe
1-2 minutes before conducting golden moment for nerve block placement and immediately after nerve block placement (less than 1 minute after)
Results posted on
2025-05-14
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
21
|
|
Overall Study
COMPLETED
|
15
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Music vs Midazolam During Preop Nerve Block Placement - Part 2 Study On Anxiolytic Options Before Peripheral Nerve Blocks
Baseline characteristics by cohort
| Measure |
Music Group
n=15 Participants
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
|
Midazolam Group
n=21 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
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Age, Continuous
|
42.7 years
STANDARD_DEVIATION 19.1 • n=93 Participants
|
42 years
STANDARD_DEVIATION 18.1 • n=4 Participants
|
42.3 years
STANDARD_DEVIATION 18.5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=93 Participants
|
21 participants
n=4 Participants
|
36 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 1-2 minutes before conducting golden moment for nerve block placement and immediately after nerve block placement (less than 1 minute after)Population: Due to lack of resources the study was terminated early and data collection is incomplete.
Spielberger State-Trait Anxiety Inventory 6 Scale range is from 20 to 80. Higher the score, the higher the anxiety level is.
Outcome measures
| Measure |
Music Group
n=15 Participants
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
|
Midazolam Group
n=21 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
|
|---|---|---|
|
Change in STAI-6 Scores From Post to Pre
Pre STAI-6
|
34 score on a scale
Standard Deviation 7.02
|
35.17 score on a scale
Standard Deviation 9.22
|
|
Change in STAI-6 Scores From Post to Pre
Post STAI-6
|
28.19 score on a scale
Standard Deviation 5.17
|
27.2 score on a scale
Standard Deviation 5.00
|
SECONDARY outcome
Timeframe: immediately after nerve block placement (less than 1 minute after)Population: Due to lack of resources the study was terminated early and data collection is incomplete.
Survey which assess satisfaction on a 10-point numeric rating scale Scale ranges from 0 to 10. A higher number indicates a higher satisfaction
Outcome measures
| Measure |
Music Group
n=15 Participants
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
|
Midazolam Group
n=21 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
|
|---|---|---|
|
Patient Satisfaction Scores of the Experience During Procedure
|
10 units on a scale
Interval 8.0 to 10.0
|
9 units on a scale
Interval 8.0 to 10.0
|
SECONDARY outcome
Timeframe: immediately after nerve block placement (less than 1 minute after)Population: Due to lack of resources the study was terminated early and data collection is incomplete.
survey which assess satisfaction on a 10-point numeric rating scale Scale ranges from 0 to 10. A higher number indicates a higher satisfaction
Outcome measures
| Measure |
Music Group
n=15 Participants
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
|
Midazolam Group
n=21 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
|
|---|---|---|
|
Provider Satisfaction Scores of the Experience During Procedure
|
10 units on a scale
Interval 9.0 to 10.0
|
10 units on a scale
Interval 8.0 to 10.0
|
SECONDARY outcome
Timeframe: immediately after nerve block placement (less than 1 minute after)Population: Due to lack of resources the study was terminated early and data collection is incomplete.
surveyed on a 5-point Likert scale Scale ranges from 1 to 5; the higher the number, the more difficult it is to communicate.
Outcome measures
| Measure |
Music Group
n=15 Participants
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
|
Midazolam Group
n=21 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
|
|---|---|---|
|
Evaluation of Difficulties in Communication From Provider to Patient and Patient to Provider
Patient Perspective
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Evaluation of Difficulties in Communication From Provider to Patient and Patient to Provider
Physician Perspective
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: start of doing the block to immediately after nerve block placement, less than 1 minute afterPopulation: Due to lack of resources the study was terminated early and data collection is incomplete.
differences amongst music and midazolam group
Outcome measures
| Measure |
Music Group
n=13 Participants
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
|
Midazolam Group
n=21 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
|
|---|---|---|
|
Block Times - Time it Took to do the Block
|
7 minutes
Standard Deviation 2.03
|
7.95 minutes
Standard Deviation 3.26
|
Adverse Events
Music Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Midazolam Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place