Music vs Midazolam During Preop Nerve Block Placement

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03069677
• Other study ID #: 826754
• Status: Completed
• Phase: Phase 3
• Start date: April 12, 2017
• Est. completion date: May 11, 2018

Study information

• Verified date: September 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Anxiety
• Peripheral Nerve Block

Intervention

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

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

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

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)