The Effect of Music Therapy On Infants Born With Gastroschisis
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Music Therapy will produce stable physiologic, states as well as, positive behavior states
研究概览
简要总结
The investigators hope to determine if music therapy will have beneficial effects on physiologic parameters, behavioral states, and pain scale evaluations in infants with gastroschisis defects and if music therapy promotes parental/caregiver relaxation and demonstrates to the parent/caregiver that music is an effective tool to calm and soothe their infant at risk for chronic gastrointestinal discomfort.
Babies will be enrolled during the perinatal period, with therapy to begin after surgical repair of the gastroschisis defect and when the neonatologist deems the baby stable enough for music therapy intervention. Enrolled subjects may receive up to 3 music therapy sessions/week and these sessions may continue until discharge. There is no follow up after discharge.
Each one hour session (20-30 minutes of music and 30 minutes of quiet) will include:
- Pre music therapy behavior state will be assessed using CRIES scale and recorded.
- Five minutes of baseline vital signs will be recorded.
- Music therapy lasting 20-30 minutes, will start. Music therapist will use guitar and lap harp to perform live lullaby tupe music with or with out vocals. Decibel levels will be maintained at 65-75dB. Session will stop if infant shows any signs of distress/agitation. Vital signs will be collected every 1-4 minutes during music session.
- After session behavior state using CRIES scale will be recorded.
- Family/caregiver will be given a questionnaire to fill out.
- 30 min of quiet will start.
- At the end of quiet time, behavior state and vital signs will be recorded for the last time.
详细描述
Prior to starting the music therapy session, family/caregivers, if present, will be informed of study session progression. They will be reminded of appropriate behavioral protocol to maintain therapeutic environment during session - i.e. minimal taking & touching, cell phones off etc. A "Do Not Disturb - Music Therapy Session in Progress" will be posted outside pts room on the door.
Behavioral state data and vitals signs collected during sessions will be entered into a database. Also recorded, will be general information about the baby and its mother, such as, gestational age, apgar scores, mothers age and race, number of days post surgical repair etc.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Week 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Gastroschisis
- •Patient is stable enough to receive music therapy as determined by Neonatologist
- •Patient has passed their newborn hearing screen
排除标准
- •Neonatologist feels patient/family would not be an acceptable research candidate.
结局指标
主要结局
Music Therapy will produce stable physiologic, states as well as, positive behavior states
时间窗: 3 years
Vital signs monitor data and stress assessment scores will be collected before, during and post Music Therapy sessions
次要结局
未报告次要终点
研究者
Ellen Bendel-Stenzel
Co-Director of NICU research - Minneapolis
Children's Hospitals and Clinics of Minnesota