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The Efficacy of Maternal Sound for Pediatric Patients Undergoing Cardiac Surgery

A

Assiut University

Status and phase

Completed
Phase 2

Conditions

Maternal-Fetal Relations

Treatments

Behavioral: Control group
Behavioral: Maternal sound group

Study type

Interventional

Funder types

Other

Identifiers

NCT02674126
IRB000087350

Details and patient eligibility

About

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.

Full 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.

Enrollment

106 patients

Sex

All

Ages

4 to 8 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

106 participants in 2 patient groups, including a placebo group

Control group
Placebo Comparator group
Description:
Control group
Treatment:
Behavioral: Control group
Maternal sound group
Active Comparator group
Description:
Maternal sound
Treatment:
Behavioral: Maternal sound group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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