About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Personalized MusicExperimental treatment 1 intervention

Group B: Standard of CareNo intervention 0 interventions

Trial outcomes

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.

Time frame

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

Secondary outcomes

1

Change in modified Yale Preoperative Anxiety Scale (mYPAS) score

mYPAS scores range from 23.3-100; a score of 30 and above is defined as high anxiety

Time frame

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

2

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

STAI is broken into two parts (STAI-S and STAI-T); scores range from 20-80 ; a STAI-S score of 40 and above is defined as high state anxiety, a STAI-T score of 52 and above is defined as high trait anxiety

Time frame

During the intra-operative period, usually about 20 minutes

3

Change in mask acceptances using Induction Compliance Checklist (ICC)

ICC scores range from 0-10, with 0 being a perfect induction

Time frame

During the intra-operative period, usually about 5 minutes

4

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

Parent/guardian satisfaction will be assessed with a qualitative 6 question survey

Time frame

During the post-operative period, usually about 45 minutes

Decreasing Emergence Agitation With Personalized Music

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts