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Completed

NCT Number: NCT02674126

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.

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Key information

Conditions

Maternal-Fetal Relations

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine

Asyut, Asyut Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control Group

Behavioral

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

Maternal sound group

Behavioral

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

Primary outcomes

  1. Blood cortisol level

    Time frame: Up to 24 hours

    Blood sample will be taken at preoperative, at sternotomy, after 10 minutes of cross clamping during cardiopulmonary bypass, during rewarming and at extubation

  2. Blood sugar level

    Time frame: Up to 24 hours

    Blood sample will be taken at preoperative, at sternotomy, after 10 minutes of cross clamping during cardiopulmonary bypass, during rewarming and at extubation

Secondary outcomes

  1. Pain assessment

    Time frame: Within the first 24 hours

    Pain assessment after extubation by Objective Pain Scale (OPS)

  2. Sedation assessment

    Time frame: Within the first 24 hours

    Sedation assessment after extubation by Richmond Agitation Sedation Scale (RASS)

  3. Post Traumatic Stress Disorder

    Time frame: Within the first postoperative week

    An interview conducted with the patients and their parents by researcher blinded to the group randomization within the first postoperative week

  4. Post hospital behavior questionnaire

    Time frame: Within the first postoperative week

    An interview conducted with the patients and their parents by researcher blinded to the group randomization within the first postoperative week

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 4, 2016
Registry last updated
Nov 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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