Clinical trial NCT02674126: The Efficacy of Maternal Sound for Pediatric Patients Undergoing Cardiac Surgery
Official title: When Are Parents Helpful? A Randomized Clinical Trial of the Efficacy of Maternal Sound for Pediatric Patients Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Maternal-Fetal Relations
Keywords: Cardiac Surgery
Maternal sound
Cortisol
Blood sugar
Stress
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-02-04
Enrollment: 106
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Blood cortisol level
timeFrame: Up to 24 hours
measure: Blood sugar level
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Pain assessment
timeFrame: Within the first 24 hours
measure: Sedation assessment
timeFrame: Within the first 24 hours
measure: Post Traumatic Stress Disorder
timeFrame: Within the first postoperative week
measure: Post hospital behavior questionnaire
timeFrame: Within the first postoperative week
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: associate professor
name: sayed abd elshafy
role: PRINCIPAL_INVESTIGATOR
References: