Music vs Midazolam During Preop Nerve Block Placement

NCT03069677 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 826754
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Peripheral Nerve Block

Keywords

midazolam

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (4)

• Patient Satisfaction Scores of the Experience During Procedure

  immediately after nerve block placement (less than 1 minute after)

• Provider Satisfaction Scores of the Experience During Procedure

  immediately after nerve block placement (less than 1 minute after)

• Evaluation of Difficulties in Communication From Provider to Patient and Patient to Provider

  immediately after nerve block placement (less than 1 minute after)

• Block Times

  immediately after nerve block placement (less than 1 minute after)

Study Arms (2)

Music group

ACTIVE COMPARATOR

research-selected music

Other: music

Midazolam group

ACTIVE COMPARATOR

IV midazolam (1mg to 2mg max)

Drug: Midazolam

Interventions

music OTHER

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

Music group

Midazolam DRUG

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

Also known as: Hypnovel

Midazolam group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Graff V, Cai L, Badiola I, Elkassabany NM. Music versus midazolam during preoperative nerve block placements: a prospective randomized controlled study. Reg Anesth Pain Med. 2019 Jul 18:rapm-2018-100251. doi: 10.1136/rapm-2018-100251. Online ahead of print.

  PMID: 31320504 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Music Therapy; Midazolam

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Veena Graff MD, MS
• Organization: University of Pennsylvania

veena.graff@uphs.upenn.edu

(215) 662-8244

Study Officials

• Veena Graff, MD, MS

  University of Pennsylvania, Anesthesia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 3, 2017
• Study Start: April 12, 2017
• Primary Completion: May 11, 2018
• Study Completion: May 11, 2018
• Last Updated: September 10, 2019
• Results First Posted: September 10, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)