Decreasing Emergence Agitation With Personalized Music

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT05044832
Status
Recruiting
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Conditions

  • Surgical Procedure, Unspecified

Eligibility Criteria

Sex
ALL
Age
3 Years - 9 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Nov 12, 2021
Status verified
Nov 2024
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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

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

Locations (2)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305
R J Ramamurthi, MD
[email protected]
650-776-6297
J Ramamurthi
R J Ramamurthi, MD (PRINCIPAL_INVESTIGATOR)
Washington UniversitySt LouisMissouri63110
Benjamin Sanofsky, MD
[email protected]
330-417-5544
Benjamin Sanofsky, MD (PRINCIPAL_INVESTIGATOR)

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