Music vs Midazolam During Preop Nerve Block Placement

Music vs Midazolam During Preoperative Nerve Block Placement: A Prospective, Randomized Controlled Study

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03069677

Enrollment

160

Registered

2017-03-03

Start date

2017-04-12

Completion date

2018-05-11

Last updated

2019-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Peripheral Nerve Block

Keywords

midazolam

Brief 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.

Detailed description

The general flow of the study will be conducted as follows: 1. Research coordinator will call or approach patients who are scheduled for a surgical procedure that is planning for a peripheral nerve block either for the primary anesthetic or for postoperative pain control to be placed in the preoperative bay in the ambulatory surgical center. 2. Research coordinator will discuss the purpose of our study and explain the study in detail for the patient. If a patient agrees to participate, then we will have the patient sign the informed consent for the study. If patient is on the phone and decides to participate, the patient will sign the informed consent upon arriving to Penn Medicine University City (PMUC). 3. Once the patient signs the informed consent for the peripheral nerve block by anesthesia team. The patient randomized will be revealed to either music or IV midazolam. The pre-procedure anxiety score will then be obtained using the STAI-6 validated tool. 4. The golden moment will be conducted between the patient, provider, and nursing staff. Once this golden moment is completed, the anxiolytic intervention will start (music or IV midazolam)\* 5. The preoperative nerve block will be conducted by the regional anesthesia block team. 6. Once the nerve block is complete, we will obtain the post-procedure anxiety score using the STAI-6 validated tool. 7. Once the post-procedure anxiety score has been obtained, we will also obtain the patient satisfaction score, the provider satisfaction score, and the evaluation of any difficulties in communication between the provider and patient. After these questions have been obtained, the study is complete.

Interventions

OTHERmusic

patients in this group will receive research-selected music after the golden moment has been completed between the patient, provider, and nursing staff

DRUGMidazolam

patients in this group will receive IV midazolam (1mg to 2mg max) after the golden moment has been completed

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

1:1

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Anxiety Levels	1-2 minutes before conducting golden moment for nerve block placement and immediately after nerve block placement (less than 1 minute after)	Spielberger State-Trait Anxiety Inventory 6 Scale range is from 20 to 80. Higher the score, the higher the anxiety level is.
Change in STAI-6 Scores From Post to Pre.	1-2 minutes before conducting golden moment for nerve block placement and immediately after nerve block placement (less than 1 minute after)	Spielberger State-Trait Anxiety Inventory 6 Scale range is from 20 to 80. Higher the score, the higher the anxiety level is.

Secondary

Measure	Time frame	Description
Patient Satisfaction Scores of the Experience During Procedure	immediately after nerve block placement (less than 1 minute after)	survey which assess satisfaction on a 10-point numeric rating scale Scale ranges from 0 to 10. A higher number indicates a higher satisfaction
Provider Satisfaction Scores of the Experience During Procedure	immediately after nerve block placement (less than 1 minute after)	survey which assess satisfaction on a 10-point numeric rating scale Scale ranges from 0 to 10. A higher number indicates a higher satisfaction
Evaluation of Difficulties in Communication From Provider to Patient and Patient to Provider	immediately after nerve block placement (less than 1 minute after)	surveyed on a 5-point Likert scale Scale ranges from 1 to 5; the higher the number, the more difficult it is to communicate.
Block Times	immediately after nerve block placement (less than 1 minute after)	differences amongst music and midaz group

Countries

United States

Participant flow

Participants by arm

Arm	Count
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	77
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	80
Total	157

Baseline characteristics

Characteristic	Music Group	Midazolam Group	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	77 Participants	80 Participants	157 Participants
Age, Continuous	45 years STANDARD_DEVIATION 15.6	46 years STANDARD_DEVIATION 16	45.5 years STANDARD_DEVIATION 15.8
Race/Ethnicity, Customized Race Asian	4 Participants	5 Participants	9 Participants
Race/Ethnicity, Customized Race Black	21 Participants	23 Participants	44 Participants
Race/Ethnicity, Customized Race Other	0 Participants	2 Participants	2 Participants
Race/Ethnicity, Customized Race White	52 Participants	50 Participants	102 Participants
Sex: Female, Male Female	52 Participants	50 Participants	102 Participants
Sex: Female, Male Male	25 Participants	30 Participants	55 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 77	0 / 80
other Total, other adverse events	0 / 77	0 / 80
serious Total, serious adverse events	0 / 77	0 / 80

Outcome results

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.

Time frame: 1-2 minutes before conducting golden moment for nerve block placement and immediately after nerve block placement (less than 1 minute after)