Clinical trial NCT02583295: The Impact of Maternal Sound on Awareness for Pediatric Patients Undergoing Cardiac Surgery
Official title: The Impact of Maternal Sound on Awareness for Pediatric Patients Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraoperative Awareness
Keywords: Awareness
Cardiac Surgery
Maternal
Pediatric
Sound
Music
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2015-10-22
Enrollment: 309
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intraoperative awareness
timeFrame: within the first 24 hours during surgery
Secondary outcomes:
measure: Duration of mechanical ventilation
timeFrame: within the first 30 days after surgery
measure: postoperative cardiac ICU stay
timeFrame: within the first 30 days after surgery
measure: hospital stay
timeFrame: within the first 30 days after surgery
measure: changes from baseline serum cortisol at postoperative period
timeFrame: Within the first 7 days postoperative
measure: changes from baseline blood sugar at postoperative period
timeFrame: Within the first 7 days postoperative
measure: child post-traumatic stress disorder (PTSD)
timeFrame: Within the first 7 days postoperative
measure: changes in behavior
timeFrame: Within the first 7 days postoperative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: associate professor
name: sayed abd elshafy, MD
role: PRINCIPAL_INVESTIGATOR
References: