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Completed

NCT Number: NCT06236477

Decreasing Emergence Delirium With Personalized Music

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.

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Key information

Age range

3 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Personalized Music

Behavioral

Music that is familiar to the child will be played via bluetooth speaker throughout their immediate perioperative care

No music

Behavioral

Participants will receive standard care without music.

Primary outcomes

  1. Pediatric Anesthesia Emergence Delirium Scale

    Time frame: day of surgery

    Assessment scale for emergence delirium.Range 0-20, higher score indicates a worse outcome

Secondary outcomes

  1. The modified Yale Preoperative Anxiety Scale

    Time frame: day of surgery

    Assessment scale for preoperative anxiety. Raw score 5-22; adjusted score range 23.33-100; higher scores indicates a worse outcome

  2. Wong-Baker Faces Pain Rating Scale

    Time frame: day of surgery

    Pain scale. Range 0-10, higher score indicates a worse outcome

  3. Face, Legs, Activity, Cry, Consolability scale

    Time frame: day of surgery

    Pain scale. Range 0-10, higher score indicates a worse outcome

  4. Induction Compliance Checklist

    Time frame: day of surgery

    Assessment scale for anxiety during mask induction of anesthesia. Range 0-10, higher score indicates a worse outcome

  5. Satisfaction survey

    Time frame: day of surgery

    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."

  6. Post Hospitalization Behavior Questionnaire

    Time frame: 1 year

    Parental assessment of behavioral changes following surgery. Range 27-135, higher score indicates a worse outcome

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • The Society for Pediatric Anesthesia

Registry information

Acronym: DEAP Music

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 1, 2024
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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