The Efficacy of Maternal Sound for Pediatric Patients Undergoing Cardiac Surgery

Phase 2

Completed

• Conditions: Maternal-Fetal Relations
• Interventions: Behavioral: Maternal sound group; Behavioral: Control group

• Registration Number: NCT02674126
• Lead Sponsor: Assiut University

Brief Summary

A newborn's recognition and preference for their mother's voice occurs early in life, very likely during fetal development. 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 effect t of maternal sound listening in children undergoing cardiac surgery on stress response and physiological parameters.

Detailed Description

Children (4 to 8 years) undergoing repair of Atrial Septal Defect (ASD). Patients will be randomized into two equal groups (30 in each group) (control group and maternal sound group); in control group patients listened to a blank CD, 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. Baseline stress markers (blood glucose and plasma cortisol) sampled the morning before scheduled operation. A interview with the patients and their parents before operation to collect the questionnaire regarding patient's characteristic (age, sex, weight and height), patient's clinical data (medical diagnosis and American Society of Anesthesiologists physical status) and haemodynamic data (blood pressure, heart rate, oxygen saturation on room air, temperature). In addition, the researcher interviewed with the mothers to record on one CD their voice while they are singing the most popular songs their children like or telling a story to their children to help them to sleep to be used during intra-operative period in maternal sound group.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-31
• Study First Submitted QC: 2016-02-02
• Study First Posted: 2016-02-04
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-04
• Last Update Posted: 2016-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Age range 4-8 years
• Elective cardiac surgery
• Atrial Septal Defect (ASD) repair with Cardiopulmonary bypass

Exclusion Criteria

• Previous cardiac surgery
• Diabetes mellitus
• Hearing impairment
• Psychiatric illness
• Neurological illness.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maternal sound group	Maternal sound group	Maternal sound
Control group	Control group	Control group

Primary Outcome Measures

Name	Time	Method
Blood cortisol level	Up to 24 hours	Blood sample will be taken at preoperative, at sternotomy, after 10 minutes of cross clamping during cardiopulmonary bypass, during rewarming and at extubation
Blood sugar level	Up to 24 hours	Blood sample will be taken at preoperative, at sternotomy, after 10 minutes of cross clamping during cardiopulmonary bypass, during rewarming and at extubation

Secondary Outcome Measures

Name	Time	Method
Pain assessment	Within the first 24 hours	Pain assessment after extubation by Objective Pain Scale (OPS)
Post hospital behavior questionnaire	Within the first postoperative week	An interview conducted with the patients and their parents by researcher blinded to the group randomization within the first postoperative week
Sedation assessment	Within the first 24 hours	Sedation assessment after extubation by Richmond Agitation Sedation Scale (RASS)
Post Traumatic Stress Disorder	Within the first postoperative week	An interview conducted with the patients and their parents by researcher blinded to the group randomization within the first postoperative week

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Assiut, Egypt