The Efficacy of Maternal Sound for Pediatric Patients Undergoing Cardiac Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Maternal-Fetal Relations
• Intervention / Treatment: Behavioral: Control group; Behavioral: Maternal sound group

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 Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group	Behavioral: Control group; 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
Active Comparator: Maternal sound group; Maternal sound	Behavioral: Maternal sound group; 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

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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: sayed abd elshafy, Associate professor

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: January 31, 2016
• First Submitted That Met QC Criteria: February 2, 2016
• First Posted (Estimate): February 4, 2016

Study Record Updates

• Last Update Posted (Estimate): November 8, 2016
• Last Update Submitted That Met QC Criteria: November 4, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Stress; Cortisol; Cardiac Surgery; Blood sugar; Maternal sound
• Other Study ID Numbers: IRB000087350

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided