Clinical Trials Directory

Trials / Completed

CompletedNCT02674126

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
106 (actual)
Sponsor
Assiut University · Academic / Other
Sex
All
Age
4 Years – 8 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALControl groupPatients 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
BEHAVIORALMaternal sound groupThe 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

Timeline

Start date
2016-01-01
Primary completion
2016-09-01
Completion
2016-09-01
First posted
2016-02-04
Last updated
2016-11-08

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT02674126. Inclusion in this directory is not an endorsement.