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The Efficacy of Maternal Sound for Pediatric Patients Undergoing Cardiac Surgery

2016年11月4日 更新者:Sayed Kaoud Abd-Elshafy、Assiut University

When Are Parents Helpful? A Randomized Clinical Trial of the Efficacy of Maternal Sound for Pediatric Patients Undergoing Cardiac Surgery

A newborn's recognition and preference for their mother's voice occurs early in life, very likely during fetal development. Maternal voice stimuli undergo a unique form of cerebral processing that lends support for the existence of neurophysiologic mechanisms that reflect a child's preference for his/her mother's voice. This study aims to evaluate and compare the effect t of maternal sound listening in children undergoing cardiac surgery on stress response and physiological parameters.

研究概览

详细说明

Children (4 to 8 years) undergoing repair of Atrial Septal Defect (ASD). Patients will be randomized into two equal groups (30 in each group) (control group and maternal sound group); in control group patients listened to a blank CD, while in maternal sound group patients listened to a recorded CD where the mother singing the most popular songs their children like or telling a story to their children. Baseline stress markers (blood glucose and plasma cortisol) sampled the morning before scheduled operation. A interview with the patients and their parents before operation to collect the questionnaire regarding patient's characteristic (age, sex, weight and height), patient's clinical data (medical diagnosis and American Society of Anesthesiologists physical status) and haemodynamic data (blood pressure, heart rate, oxygen saturation on room air, temperature). In addition, the researcher interviewed with the mothers to record on one CD their voice while they are singing the most popular songs their children like or telling a story to their children to help them to sleep to be used during intra-operative period in maternal sound group.

研究类型

介入性

注册 (实际的)

106

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Assiut、埃及
        • Faculty of Medicine

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

4年 至 8年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age range 4-8 years
  • Elective cardiac surgery
  • Atrial Septal Defect (ASD) repair with Cardiopulmonary bypass

Exclusion Criteria:

  • Previous cardiac surgery
  • Diabetes mellitus
  • Hearing impairment
  • Psychiatric illness
  • Neurological illness.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
安慰剂比较:控制组
Patients in the control group listened to a blank CD connected to the patient ears before induction of anesthesia and continued during intra operative period till extubation in intensive care unit
有源比较器:Maternal sound group
Maternal sound
The recorded maternal voice (while they are singing the most popular songs their children like or telling a story to help their children to sleep) listened by CD player connected to the patient ears before induction of anesthesia and continued during intra operative period till extubation in intensive care unit

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Blood cortisol level
大体时间:Up to 24 hours
Blood sample will be taken at preoperative, at sternotomy, after 10 minutes of cross clamping during cardiopulmonary bypass, during rewarming and at extubation
Up to 24 hours
Blood sugar level
大体时间:Up to 24 hours
Blood sample will be taken at preoperative, at sternotomy, after 10 minutes of cross clamping during cardiopulmonary bypass, during rewarming and at extubation
Up to 24 hours

次要结果测量

结果测量
措施说明
大体时间
Pain assessment
大体时间:Within the first 24 hours
Pain assessment after extubation by Objective Pain Scale (OPS)
Within the first 24 hours
Sedation assessment
大体时间:Within the first 24 hours
Sedation assessment after extubation by Richmond Agitation Sedation Scale (RASS)
Within the first 24 hours
Post Traumatic Stress Disorder
大体时间:Within the first postoperative week
An interview conducted with the patients and their parents by researcher blinded to the group randomization within the first postoperative week
Within the first postoperative week
Post hospital behavior questionnaire
大体时间:Within the first postoperative week
An interview conducted with the patients and their parents by researcher blinded to the group randomization within the first postoperative week
Within the first postoperative week

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:sayed abd elshafy、Associate professor

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2016年1月1日

初级完成 (实际的)

2016年9月1日

研究完成 (实际的)

2016年9月1日

研究注册日期

首次提交

2016年1月31日

首先提交符合 QC 标准的

2016年2月2日

首次发布 (估计)

2016年2月4日

研究记录更新

最后更新发布 (估计)

2016年11月8日

上次提交的符合 QC 标准的更新

2016年11月4日

最后验证

2016年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • IRB000087350

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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