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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
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02674126
Enrollment
106
Registered
2016-02-04
Start date
2016-01-31
Completion date
2016-09-30
Last updated
2016-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal-Fetal Relations

Keywords

Cardiac Surgery, Maternal sound, Cortisol, Blood sugar, Stress

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.

Interventions

BEHAVIORALControl 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

BEHAVIORALMaternal 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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Blood cortisol levelUp to 24 hoursBlood sample will be taken at preoperative, at sternotomy, after 10 minutes of cross clamping during cardiopulmonary bypass, during rewarming and at extubation
Blood sugar levelUp to 24 hoursBlood sample will be taken at preoperative, at sternotomy, after 10 minutes of cross clamping during cardiopulmonary bypass, during rewarming and at extubation

Secondary

MeasureTime frameDescription
Pain assessmentWithin the first 24 hoursPain assessment after extubation by Objective Pain Scale (OPS)
Sedation assessmentWithin the first 24 hoursSedation assessment after extubation by Richmond Agitation Sedation Scale (RASS)
Post Traumatic Stress DisorderWithin the first postoperative weekAn interview conducted with the patients and their parents by researcher blinded to the group randomization within the first postoperative week
Post hospital behavior questionnaireWithin the first postoperative weekAn interview conducted with the patients and their parents by researcher blinded to the group randomization within the first postoperative week

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026