Trial Outcomes & Findings for Music vs Midazolam During Preop Nerve Block Placement (NCT NCT03069677)
NCT ID: NCT03069677
Last Updated: 2019-09-10
Results Overview
Spielberger State-Trait Anxiety Inventory 6 Scale range is from 20 to 80. Higher the score, the higher the anxiety level is.
COMPLETED
PHASE3
160 participants
1-2 minutes before conducting golden moment for nerve block placement and immediately after nerve block placement (less than 1 minute after)
2019-09-10
Participant Flow
Participant milestones
| Measure |
Music Group
research-selected music
music: patients in this group will receive research-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
|
80
|
80
|
|
Overall Study
COMPLETED
|
77
|
77
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Music vs Midazolam During Preop Nerve Block Placement
Baseline characteristics by cohort
| Measure |
Music Group
n=77 Participants
research-selected music
music: patients in this group will receive research-selected music after the golden moment has been completed between the patient, provider, and nursing staff
|
Midazolam Group
n=80 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=157 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
77 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
157 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 15.6 • n=99 Participants
|
46 years
STANDARD_DEVIATION 16 • n=107 Participants
|
45.5 years
STANDARD_DEVIATION 15.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
52 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
21 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 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: there was incomplete collection of data and patients dropped out which resulted in 77 total analyzed participants in this group
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=77 Participants
research-selected music
music: patients in this group will receive research-selected music after the golden moment has been completed between the patient, provider, and nursing staff
|
Midazolam Group
n=80 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
|
|---|---|---|
|
Anxiety Levels
Pre-STAI-6 Scores
|
33.3 score on a scale
Interval 23.3 to 41.7
|
30 score on a scale
Interval 20.0 to 40.0
|
|
Anxiety Levels
Post-STAI-6 Scores
|
30 score on a scale
Interval 20.0 to 40.0
|
23.3 score on a scale
Interval 20.0 to 33.3
|
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: there was incomplete collection of data and patients dropped out which resulted in 77 total analyzed participants in this group
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=77 Participants
research-selected music
music: patients in this group will receive research-selected music after the golden moment has been completed between the patient, provider, and nursing staff
|
Midazolam Group
n=80 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.
|
-1.6 score on a scale
Standard Deviation 10.7
|
-4.2 score on a scale
Standard Deviation 11
|
SECONDARY outcome
Timeframe: immediately after nerve block placement (less than 1 minute after)Population: there was incomplete collection of data and patients dropped out which resulted in 77 total analyzed participants in this group
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=77 Participants
research-selected music
music: patients in this group will receive research-selected music after the golden moment has been completed between the patient, provider, and nursing staff
|
Midazolam Group
n=80 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
|
8 units on a scale
Interval 5.0 to 9.0
|
9 units on a scale
Interval 7.0 to 10.0
|
SECONDARY outcome
Timeframe: immediately after nerve block placement (less than 1 minute after)Population: there was incomplete collection of data and patients dropped out which resulted in 77 total analyzed participants in this group
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=77 Participants
research-selected music
music: patients in this group will receive research-selected music after the golden moment has been completed between the patient, provider, and nursing staff
|
Midazolam Group
n=80 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
|
9 units on a scale
Interval 8.0 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: there was incomplete collection of data and patients dropped out which resulted in 77 total analyzed participants in this group
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=77 Participants
research-selected music
music: patients in this group will receive research-selected music after the golden moment has been completed between the patient, provider, and nursing staff
|
Midazolam Group
n=80 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 on Communication
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 1.0
|
|
Evaluation of Difficulties in Communication From Provider to Patient and Patient to Provider
Physician Perspective on Communication
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: immediately after nerve block placement (less than 1 minute after)Population: there was incomplete collection of data and patients dropped out which resulted in 77 total analyzed participants in this group
differences amongst music and midaz group
Outcome measures
| Measure |
Music Group
n=77 Participants
research-selected music
music: patients in this group will receive research-selected music after the golden moment has been completed between the patient, provider, and nursing staff
|
Midazolam Group
n=80 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
|
6.7 minutes
Standard Deviation 4.2
|
7 minutes
Standard Deviation 4.2
|
Adverse Events
Music Group
Midazolam Group
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