Decreasing Emergence Agitation With Personalized Music

NCT05044832 | Recruiting

• 1 other identifier: 62474
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the study is to assess the impact of personalized music on emergence agitation (EA), as measured by Pediatric Anesthesia Emergence Delirium scores in pediatric patients recovering from elective procedures under general anesthesia. Personalized music may help to decrease EA in children undergoing elective surgeries under general anesthesia by decreasing perioperative anxiety and minimizing perceived pain. The study has the potential to improve perioperative care by improving safety, decreasing the need for postoperative pharmacologic and nursing interventions, thereby shortening the time of recovery and improving caregiver satisfaction. Participants participating in this study will be randomly assigned to receive personalized music plus standard of care, or standard of care alone. Those assigned to the music group will receive music in the preoperative holding area as well as in the post-operative care unit.

Conditions

Surgical Procedure, Unspecified

Keywords

eardrum procedures; laser treatment for skin lesions; adenoidectomy without tonsillectomy; tonsillectomy with or without adenoidectomy

Outcome Measures

Primary Outcomes (1)

• Change in Pediatric Anesthesia Emergence Delirium (PAED) scores

  Personalized music may help to decrease EA in children undergoing elective surgeries under general anesthesia by decreasing perioperative anxiety and minimizing perceived pain. PAED scores range from 0 to 20; a score of 10 and above is defined as emergence agitation.

  During post operative period till the child is fully awake, usually about 45 minutes.

Secondary Outcomes (5)

• Change in modified Yale Preoperative Anxiety Scale (mYPAS) score

  During the pre-operative period, until the child is asleep under general anesthesia, usually about 20 minutes

• Change in patient response to personalized music in relation to parental anxiety using State and Trait Anxiety (STAI) scores (parent-reported)

  During the intra-operative period, usually about 20 minutes

• Change in mask acceptances using Induction Compliance Checklist (ICC)

  During the intra-operative period, usually about 5 minutes

• Change in parental satisfaction with the patient's perioperative experience using a post-operative parental satisfaction survey

  During the post-operative period, usually about 45 minutes

• Change in post-operative pain

  During the post-operative period, usually about 20 minutes

Study Arms (2)

Personalized Music

EXPERIMENTAL

Those assigned to the music group will receive music in the preoperative holding area as well as in the post-operative care unit in addition to standard care.

Behavioral: Personalized Music

Standard of Care

NO INTERVENTION

Those assigned to the Standard of Care arm will only receive standard of care in the preoperative holding area as well as in the post-operative care unit

Interventions

Personalized Music BEHAVIORAL

Personalized music delivered during the perioperative and post-operative periods. Those assigned to the music group will receive music in the preoperative holding area as well as in the post-operative care unit.

Personalized Music

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• patient ages 3-9 (chosen due to high incidence of emergence delirium and presence of musical memory seen in this age group)
• unilateral or bilateral myringotomy procedure, laser treatment for skin lesions, adenoidectomy without tonsillectomy
• tonsillectomy with or without adenoidectomy

You may not qualify if:

• Chronic intake of any sedative or analgesic medication
• Surgical or anesthetic complications (including use of invasive airway device for myringotomy)
• History of significant hearing loss impeding the ability to hear music
• Lack of interest in music reported by parents or inability to identify personally meaningful music

Sponsors & Collaborators

• Stanford University: lead
• University of Vermont Medical Center: collaborator

Study Sites (2)

Stanford University

Stanford, California, 94305, United States

RECRUITING

Washington University

St Louis, Missouri, 63110, United States

RECRUITING

Study Officials

• R J Ramamurthi, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jyoti Bhamidipati, MBBS

CONTACT

650 229 2144; jyotib@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Anesthesiology

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 16, 2021
• Study Start: November 12, 2021
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)