The Efficacy of Maternal Sound for Pediatric Patients Undergoing Cardiac Surgery

Study Overview
=================
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.

Official Title
-----------------
When Are Parents Helpful? A Randomized Clinical Trial of the Efficacy of Maternal Sound for Pediatric Patients Undergoing Cardiac Surgery

Conditions
-----------------
Maternal-Fetal Relations

Intervention / Treatment
-----------------
* Behavioral: Control group
* Behavioral: Maternal sound group


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>Control group | Behavioral: Control group<br>* Patients in the control group listened to a blank CD connected to the patient ears before induction of anesthesia and continued during intra operative period till extubation in intensive care unit<br>|
| Active Comparator: Maternal sound group<br>Maternal sound | Behavioral: Maternal sound group<br>* The recorded maternal voice (while they are singing the most popular songs their children like or telling a story to help their children to sleep) listened by CD player connected to the patient ears before induction of anesthesia and continued during intra operative period till extubation in intensive care unit<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood cortisol level | Blood sample will be taken at preoperative, at sternotomy, after 10 minutes of cross clamping during cardiopulmonary bypass, during rewarming and at extubation | Up to 24 hours | 
| Blood sugar level | Blood sample will be taken at preoperative, at sternotomy, after 10 minutes of cross clamping during cardiopulmonary bypass, during rewarming and at extubation | Up to 24 hours | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac Surgery, Maternal sound, Cortisol, Blood sugar, Stress