NCT02674126

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 4, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

November 8, 2016

Status Verified

November 1, 2016

Enrollment Period

8 months

First QC Date

January 31, 2016

Last Update Submit

November 4, 2016

Conditions

Maternal-Fetal Relations

Keywords

Cardiac SurgeryMaternal soundCortisolBlood sugarStress

Outcome Measures

Primary Outcomes (2)

  • Blood cortisol level

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

    Up to 24 hours

  • Blood sugar level

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

    Up to 24 hours

Secondary Outcomes (4)

  • Pain assessment

    Within the first 24 hours

  • Sedation assessment

    Within the first 24 hours

  • Post Traumatic Stress Disorder

    Within the first postoperative week

  • Post hospital behavior questionnaire

    Within the first postoperative week

Study Arms (2)

Control group

PLACEBO COMPARATOR

Control group

Behavioral: Control group

Maternal sound group

ACTIVE COMPARATOR

Maternal sound

Behavioral: Maternal sound group

Interventions

Control groupBEHAVIORAL

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

Control group
Maternal sound groupBEHAVIORAL

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

Maternal sound group

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age range 4-8 years
  • Elective cardiac surgery
  • Atrial Septal Defect (ASD) repair with Cardiopulmonary bypass

You may not qualify if:

  • Previous cardiac surgery
  • Diabetes mellitus
  • Hearing impairment
  • Psychiatric illness
  • Neurological illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Asyut, Asyut Governorate, Egypt

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • sayed abd elshafy

    associate professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University

Study Record Dates

First Submitted

January 31, 2016

First Posted

February 4, 2016

Study Start

January 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

November 8, 2016

Record last verified: 2016-11

Locations

EG(1)