Decreasing Emergence Agitation With Personalized Music
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Stanford University
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Change in Pediatric Anesthesia Emergence Delirium (PAED) scores
Study Overview
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.
Detailed Description
Study Protocol:
This is a prospective, randomized controlled trial of children 3-9 years of undergoing non-complex ENT procedures to assess the impact of perioperative personalized music on the incidence of emergence agitation (EA).
There will be 2 groups in the study:
- Personalized music group
- Standard care group
All patients enrolled in this study will receive a standardized anesthetic consistent with standard practice at the Stanford Children's Hospital based on their type of procedure:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 9 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Personalized Music (Behavioral)
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
Outcomes
Primary Outcomes
Change in Pediatric Anesthesia Emergence Delirium (PAED) scores
Time Frame: During post operative period till the child is fully awake, usually about 45 minutes.
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.
Secondary Outcomes
- 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 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 mask acceptances using Induction Compliance Checklist (ICC)(During the intra-operative period, usually about 5 minutes)
- 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 post-operative pain(During the post-operative period, usually about 20 minutes)
Investigators
R J Ramamurthi
Clinical Professor, Anesthesiology
Stanford University