Clinical Trial: The Impact of Maternal Sound on Awareness for Pediatric Patients Undergoing Cardiac Surgery

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Impact of Maternal Sound on Awareness for Pediatric Patients Undergoing Cardiac Surgery

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Assiut University

Current Primary Outcome: Intraoperative awareness [ Time Frame: 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)


Original Primary Outcome: Intra-operative awareness assessed using the bi spectral index (BIS) [ Time Frame: within the first 24 hours during surgery ]

Bispectral index (BIS) is a numerical index and on-line measure of hypnotic state and a reportedly valuable predictor of consciousness and recall with various anesthetic regimens. The Bispectral index monitor generates a dimensionless number on a continuous scale of 0-100, with 100 representing normal cortical electri¬cal activity and 0 indicating cortical electrical silence. A BIS index less than 40 represents deep hypnosis. Values between 40 and 60 indicate adequate general anesthesia, reflected by absence of response to command, alertness, and recall. Furthermore, titration of anesthesia to BIS 40-60 appears clinically useful in terms of reduction in anesthetic requirement, reduction in the incidence of nausea and vomiting , reduction in the incidence of intraoperative awareness and improve postoperative recovery


Current Secondary Outcome:

  • Duration of mechanical ventilation [ Time Frame: within the first 30 days after surgery ]
    duration of postoperative mechanical ventilation reported in hours
  • postoperative cardiac ICU stay [ Time Frame: within the first 30 days after surgery ]
    length of stay in the postoperative cardiac ICU (days)
  • hospital stay [ Time Frame: within the first 30 days after surgery ]
    length of stay in the hospital (days)
  • changes from baseline serum cortisol at postoperative period [ Time Frame: Within the first 7 days postoperative ]
    changes from baseline serum cortisol at postoperative period
  • changes from baseline blood sugar at postoperative period [ Time Frame: Within the first 7 days postoperative ]
    changes from baseline blood sugar at postoperative period
  • child post-traumatic stress disorder (PTSD) [ Time Frame: Within the first 7 days postoperative ]
    child post-traumatic stress disorder (PTSD) by special scale questionnaire
  • changes in behavior [ Time Frame: Within the first 7 days postoperative ]
    changes in physiological and psychosocial behaviors of children by questionnaire


Original Secondary Outcome:

  • Duration of mechanical ventilation [ Time Frame: within the first 30 days after surgery ]
    duration of postoperative mechanical ventilation reported in hours
  • postoperative cardiac ICU stay [ Time Frame: within the first 30 days after surgery ]
    length of stay in the postoperative cardiac ICU (days)
  • hospital stay [ Time Frame: within the first 30 days after surgery ]
    length of stay in the hospital (days)


Information By: Assiut University

Dates:
Date Received: October 10, 2015
Date Started: June 2016
Date Completion: May 2017
Last Updated: May 16, 2017
Last Verified: May 2017