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临床试验/NCT06236477
NCT06236477
进行中(未招募)
1 期

Decreasing Emergence Delirium With Personalized Music

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 160 人2024年1月26日

概览

阶段
1 期
干预措施
Personalized Music
疾病 / 适应症
Emergence Delirium
发起方
Washington University School of Medicine
入组人数
160
试验地点
1
主要终点
Pediatric Anesthesia Emergence Delirium Scale
状态
进行中(未招募)
最后更新
2个月前

概览

简要总结

This is a prospective randomized controlled trial in children 3-9 years of age undergoing myringotomies at Washington University in St. Louis to assess the impact of perioperative personalized music on the incidence of emergence agitation.

详细描述

Aim 1: Determine the efficacy of personalized music in decreasing the incidence of emergence agitation in pediatric patients undergoing myringotomies. Patients undergoing myringotomy procedures will be randomized to receive either standard care or personalized music during the perioperative period. The incidence of emergence agitation will be determined using the Pediatric Anesthesia Emergence Delirium scale. Aim 2: Determine the efficacy of personalized music in reducing preoperative anxiety, postoperative pain, and maladaptive behavioral changes in pediatric patients following myringotomy procedures. Anxiety will be assessed in the preoperative holding area using the modified Yale Preoperative Anxiety Scale and the Induction Compliance Checklist (mask acceptance). Postoperative pain will be assessed in the post-anesthesia care unit using the Face, Legs, Activity, Cry, Consolability and Wong-Baker FACES scales. Behavioral changes will be measured using the Post Hospitalization Behavior Questionnaire via telephone calls on postoperative days 1 and 14 after discharge.

注册库
clinicaltrials.gov
开始日期
2024年1月26日
结束日期
2026年3月28日
最后更新
2个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Benjamin A Sanofsky

Anesthesiologist

Washington University School of Medicine

入排标准

入选标准

  • Child aged 3-9 years
  • Presenting for unilateral or bilateral myringotomy under GA

排除标准

  • Combined procedures
  • Lack of interest in music (e.g., child who does not have musical preferences)
  • Inability to hear music (patients with mild-moderate hearing loss who can perceive music will be included)
  • Parent/guardian or patient refusal

研究组 & 干预措施

Personalized Music Group

Those assigned to receive music will be asked to provide a short list of 5-10 songs familiar/well-known to the patient (specifically the song title and artist for each song). Songs will be downloaded onto an electronic mp3 player by the research staff member. The mp3 player will then be provided along with a portable Bluetooth speaker for use during the patient's perioperative period, loaded with the songs of their choice.

干预措施: Personalized Music

No Music Group

Those not assigned to the personalized music group will receive standard care without music.

干预措施: No Music

结局指标

主要结局

Pediatric Anesthesia Emergence Delirium Scale

时间窗: day of surgery

Assessment scale for emergence delirium.Range 0-20, higher score indicates a worse outcome

次要结局

  • Wong-Baker Faces Pain Rating Scale(day of surgery)
  • The modified Yale Preoperative Anxiety Scale(day of surgery)
  • Satisfaction survey(day of surgery)
  • Post Hospitalization Behavior Questionnaire(1 year)
  • Face, Legs, Activity, Cry, Consolability scale(day of surgery)
  • Induction Compliance Checklist(day of surgery)

研究点 (1)

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