Recruiting

Personalized Music

Sponsor:

Stanford University

Code:

NCT05044832

Conditions

Surgical Procedure, Unspecified

Eligibility Criteria

Sex: All

Age: 3 - 9

Healthy Volunteers: Not accepted

Interventions

Personalized Music

Study Details

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

Study ID

NCT05044832

Start date

Nov 12, 2021

Status verified date

Nov, 2024

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 9

Healthy Volunteers: Not accepted

Inclusion Criteria

  • 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

Exclusion Criteria

  • Chronic intake of any sedative or analgesic medication
  • Combined surgical procedure not otherwise listed in inclusion criteria
  • 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Personalized Music

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.

no intervention: Standard of Care

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

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.

Primary outcome measure

  • Change in Pediatric Anesthesia Emergence Delirium (PAED) scores [ Time Frame: During post operative period till the child is fully awake, usually about 45 minutes. ]

Central Contacts and Locations

Central contacts

Jyoti Bhamidipati, MBBS

650 229 2144jyotib@stanford.edu

Locations

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

R J Ramamurthi, MD

650-776-6297rjram@stanford.edu

Principal Investigator:

R J Ramamurthi, MD

Washington University

Recruiting

Saint Louis, Missouri, United States, 63110

Contacts

Benjamin Sanofsky, MD

330-417-5544sanofsky@wustl.edu

Principal Investigator:

Benjamin Sanofsky, MD

More Information

Sponsor

Stanford University

Last update posted

Nov 22, 2024

Last verified

Nov, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Stanford University on 2024-11-22.