The Impact of Maternal Sound on Awareness for Pediatric Patients Undergoing Cardiac Surgery
2017年10月18日 更新者:Sayed Kaoud Abd-Elshafy、Assiut University
Awareness during anesthesia with intraoperative memory occurs when the patient is able to process information and produce specific responses to several stimuli.
Anecdotal evidence suggests that children exposed to therapeutic suggestion consisting of gently encouraging, positive words spoken to them during emergence from anesthesia seem to arouse after surgery with less agitation, less pain and lower requirements for pain medications.
Therapeutic suggestion has been associated with positive results in some adults during surgery, but it is unknown how therapeutic suggestion affects children.
A newborn's recognition and preference for their mother's voice occurs early in life, very likely during fetal development.
Additional evidence, revealed that at least as early as 4 months of age, infants process auditory stimuli from their mother's voice at a higher amplitude than they process auditory input from female strangers, suggesting that 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 possibility of intra-operative awareness prevention by using either music listening or maternal sound listening in children undergoing cardiac surgery.
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 groups (music group and maternal sound group); in music group patients listened to a recorded CD by music and songs preferred by the child, 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.
In both groups bi spectral index (BIS) to detect depth of anesthesia.
An interview will be conducted with the patients and their parent within the first postoperative week by a semi-structured in-depth questionnaire to evaluate occurrence of awareness.
研究类型
介入性
注册 (实际的)
309
阶段
- 不适用
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:
- patients in the age range 4-8 years scheduled for elective cardiac surgery for Atrial Septal Defect (ASD) repair with Cardiopulmonary bypass
Exclusion Criteria:
- Patients with previous cardiac surgery, diabetes mellitus, hearing impairment and psychiatric or neurological illness were excluded from this study.
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 |
|---|---|
|
有源比较器:Maternal sound group
Maternal sound
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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
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有源比较器:Music group
Music sound
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The recorded preferred songs or music (commercially available) listened by CD player connected to the patient ears before induction of anesthesia and continued during intra operative period
|
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 |
|---|---|---|
|
Intraoperative awareness
大体时间:within the first 24 hours during surgery
|
by using a semi-structured in-depth questionnaire (a qualitative method adapted to assess memory development and language level in children to encourage their recall quality and reduce their suggestibility)
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within the first 24 hours during surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Duration of mechanical ventilation
大体时间:within the first 30 days after surgery
|
duration of postoperative mechanical ventilation reported in hours
|
within the first 30 days after surgery
|
|
postoperative cardiac ICU stay
大体时间:within the first 30 days after surgery
|
length of stay in the postoperative cardiac ICU (days)
|
within the first 30 days after surgery
|
|
hospital stay
大体时间:within the first 30 days after surgery
|
length of stay in the hospital (days)
|
within the first 30 days after surgery
|
|
changes from baseline serum cortisol at postoperative period
大体时间:Within the first 7 days postoperative
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changes from baseline serum cortisol at postoperative period
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Within the first 7 days postoperative
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changes from baseline blood sugar at postoperative period
大体时间:Within the first 7 days postoperative
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changes from baseline blood sugar at postoperative period
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Within the first 7 days postoperative
|
|
child post-traumatic stress disorder (PTSD)
大体时间:Within the first 7 days postoperative
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child post-traumatic stress disorder (PTSD) by special scale questionnaire
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Within the first 7 days postoperative
|
|
changes in behavior
大体时间:Within the first 7 days postoperative
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changes in physiological and psychosocial behaviors of children by questionnaire
|
Within the first 7 days postoperative
|
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, MD、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 (实际的)
2016年6月15日
初级完成 (实际的)
2017年9月1日
研究完成 (实际的)
2017年9月1日
研究注册日期
首次提交
2015年10月10日
首先提交符合 QC 标准的
2015年10月20日
首次发布 (估计)
2015年10月22日
研究记录更新
最后更新发布 (实际的)
2017年10月19日
上次提交的符合 QC 标准的更新
2017年10月18日
最后验证
2017年10月1日
更多信息
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.