Decreasing Emergence Delirium With Personalized Music

Emergence Delirium Clinical Trial

— DEAP Music  

Official title:

Decreasing Emergence Delirium With Personalized Music

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06236477
• Other study ID #: 202309122
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 26, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Washington University School of Medicine
• Contact: Benjamin Sanofsky
• Phone: 314-457-3109
• Email: sanofsky[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective randomized controlled trial in children 3-9 years of age undergoing myringotomies at Washington University in St. Louis to assess the impact of perioperative personalized music on the incidence of emergence agitation.

Description:

Aim 1: Determine the efficacy of personalized music in decreasing the incidence of emergence agitation in pediatric patients undergoing myringotomies. Patients undergoing myringotomy procedures will be randomized to receive either standard care or personalized music during the perioperative period. The incidence of emergence agitation will be determined using the Pediatric Anesthesia Emergence Delirium scale. Aim 2: Determine the efficacy of personalized music in reducing preoperative anxiety, postoperative pain, and maladaptive behavioral changes in pediatric patients following myringotomy procedures. Anxiety will be assessed in the preoperative holding area using the modified Yale Preoperative Anxiety Scale and the Induction Compliance Checklist (mask acceptance). Postoperative pain will be assessed in the post-anesthesia care unit using the Face, Legs, Activity, Cry, Consolability and Wong-Baker FACES scales. Behavioral changes will be measured using the Post Hospitalization Behavior Questionnaire via telephone calls on postoperative days 1 and 14 after discharge.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 9 Years

Eligibility

Inclusion Criteria:

• Child aged 3-9 years
• Presenting for unilateral or bilateral myringotomy under GA

Exclusion Criteria:

• Combined procedures
• Lack of interest in music (e.g., child who does not have musical preferences)
• Inability to hear music (patients with mild-moderate hearing loss who can perceive music will be included)
• Parent/guardian or patient refusal

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium

Intervention

Behavioral:
• Personalized Music
Music that is familiar to the child will be played via bluetooth speaker throughout their immediate perioperative care
• No Music
Participants will receive standard care without music.

Locations

Country	Name	City	State
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	The Society for Pediatric Anesthesia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pediatric Anesthesia Emergence Delirium Scale	Assessment scale for emergence delirium.Range 0-20, higher score indicates a worse outcome	day of surgery
Secondary	The modified Yale Preoperative Anxiety Scale	Assessment scale for preoperative anxiety. Raw score 5-22; adjusted score range 23.33-100; higher scores indicates a worse outcome	day of surgery
Secondary	Wong-Baker Faces Pain Rating Scale	Pain scale. Range 0-10, higher score indicates a worse outcome	day of surgery
Secondary	Face, Legs, Activity, Cry, Consolability scale	Pain scale. Range 0-10, higher score indicates a worse outcome	day of surgery
Secondary	Induction Compliance Checklist	Assessment scale for anxiety during mask induction of anesthesia. Range 0-10, higher score indicates a worse outcome	day of surgery
Secondary	Satisfaction survey	Survey of parental satisfaction with perioperative care. A qualitative survey with discrete questions that contain "yes" or "no" or likert-style ratings ranging from "strongly disagree" to "strongly agree."	day of surgery
Secondary	Post Hospitalization Behavior Questionnaire	Parental assessment of behavioral changes following surgery. Range 27-135, higher score indicates a worse outcome	1 year