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临床试验/NCT00178217
NCT00178217已完成1 期

Music Therapy as Procedural Support During Botulinum Injections for Pediatric Patients

University of Rochester2 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2002年7月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
101
试验地点
2
主要终点
Music therapy will be effectively integrated as a means of procedural support for children undergoing botox injections with a success rate of 80% in enrolling, treating and collecting data from study subjects.

研究概览

简要总结

The primary objectives for this study are:

  1. To demonstrate that music therapy can be an effective means of procedural support for children undergoing botox injections.
  2. To explore patient, parent and healthcare personnel satisfaction with music therapy as procedural support.
  3. To assess the influence of music therapy on physiologic (blood pressure, oxygen saturation, heart rate) and emotional (crying time) responses of patients.

详细描述

Many children with spastic Cerebral Palsy and other types of muscle dystonia are injected with Botulinum toxin A (Botox) to reduce pathological reflexes and improve muscle function. Such treatment requires injections to each affected muscle group, which can be both painful and distressing. Music therapy has been shown to reduce pain and decrease stress and anxiety for pediatric patients undergoing other types of medical procedures.

The goal of this study is to determine whether music therapy can be effectively integrated as a means of procedural support during Botox injections. This study investigates the efficacy of music therapy in reducing manifestations of pain during Botox injections. Secondary benefits may include increased satisfaction among medical personnel and parents.

Patients between the ages of 2-17 being treated with Botox were eligible for enrollment. Prior to the start of this study, patients had the option of receiving music therapy support during their Botox injections; these subjects continued to receive music therapy upon enrolling in the study. Subjects who had not previously received music therapy were videotaped for two Botox sessions before having a music therapy intervention. The percentage of crying time during the procedure was calculated from videotapes taken during the sessions. Surveys were given to parent/guardians and the healthcare provider performing the procedure to provide feedback on the effectiveness of the music intervention for the child and themselves.

Comparing average crying times for 44 children's first study visit with or without music therapy shows that children who receive music therapy cry less than children who do not, although the difference is not statistically significant. Both parent and healthcare provider surveys indicate a high level of satisfaction with the music therapy intervention.

The current data indicate that music therapy may be a highly effective means of procedural support, but strong conclusions cannot be drawn without more data.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
1 Year 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Treatment for diplegic or hemiplegic cerebral palsy or muscle spasticity resulting from brain injury, with Botulinum toxin injections.

排除标准

  • 未提供

结局指标

主要结局

Music therapy will be effectively integrated as a means of procedural support for children undergoing botox injections with a success rate of 80% in enrolling, treating and collecting data from study subjects.

时间窗: End of study

Music therapy will increase satisfaction by decreasing the distress related to botox injections for child, parent and medical staff.

时间窗: From beginning to end of session

Subjects receiving music therapy will demonstrate less procedure-related distress as manifested by: Less of an increase in blood pressure and heart rate, less of a decrease in oxygen saturation, and a lower proportion of procedure time spent crying

时间窗: From beginning to end of session

次要结局

  • When patients receive music therapy, they will be more likely to undergo Botox injections without the use of sedation.(By end of study)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

OJ Sahler

Professor of Pediatrics, Psychiatry, Medical Humanities & Oncology

University of Rochester

研究点 (2)

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