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

Not Applicable

Completed

• Conditions: Intraoperative Awareness
• Interventions: Behavioral: Music sound; Behavioral: Maternal sound

• Registration Number: NCT02583295
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2015-10-10
• Study First Submitted QC: 2015-10-20
• Study First Posted: 2015-10-22
• Study Start: 2016-06-15
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-18
• Last Update Posted: 2017-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 309

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music group	Music sound	Music sound
Maternal sound group	Maternal sound	Maternal sound

Primary Outcome Measures

Name	Time	Method
Intraoperative awareness	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Assiut, Egypt