The Impact of Maternal Sound on Awareness for Pediatric Patients Undergoing Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 309
- 试验地点
- 1
- 主要终点
- Intraoperative awareness
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients in the age range 4-8 years scheduled for elective cardiac surgery for Atrial Septal Defect (ASD) repair with Cardiopulmonary bypass
排除标准
- •Patients with previous cardiac surgery, diabetes mellitus, hearing impairment and psychiatric or neurological illness were excluded from this study.
研究组 & 干预措施
Music group
Music sound
干预措施: Music sound (Behavioral)
Maternal sound group
Maternal sound
干预措施: Maternal sound (Behavioral)
结局指标
主要结局
Intraoperative awareness
时间窗: 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)
次要结局
- hospital stay(within the first 30 days after surgery)
- postoperative cardiac ICU stay(within the first 30 days after surgery)
- Duration of mechanical ventilation(within the first 30 days after surgery)
- changes from baseline serum cortisol at postoperative period(Within the first 7 days postoperative)
- changes from baseline blood sugar at postoperative period(Within the first 7 days postoperative)
- child post-traumatic stress disorder (PTSD)(Within the first 7 days postoperative)
- changes in behavior(Within the first 7 days postoperative)
研究者
Sayed Kaoud Abd-Elshafy
Associate Professor (Anesthesiology and Critical Care)- College of Medicine
Assiut University