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The Efficacy of Maternal Sound for Pediatric Patients Undergoing Cardiac Surgery

NCT ID: NCT02674126

Last Updated: 2016-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-09-30

Brief Summary

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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

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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

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Maternal-Fetal Relations

Keywords

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Cardiac Surgery Maternal sound Cortisol Blood sugar Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control group

Control group

Group Type PLACEBO_COMPARATOR

Control group

Intervention Type 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

Maternal sound

Group Type ACTIVE_COMPARATOR

Maternal sound group

Intervention Type 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

Interventions

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Control 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

Intervention Type BEHAVIORAL

Maternal 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Sayed Kaoud Abd-Elshafy

Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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sayed abd elshafy

Role: PRINCIPAL_INVESTIGATOR

associate professor

Locations

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Faculty of Medicine

Asyut, Asyut Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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IRB000087350

Identifier Type: -

Identifier Source: org_study_id