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The Impact of Maternal Sound on Awareness for Pediatric Patients Undergoing Cardiac Surgery

NCT ID: NCT02583295

Last Updated: 2017-10-19

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

NA

Total Enrollment

309 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-15

Study Completion Date

2017-09-30

Brief Summary

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Awareness during anesthesia with intraoperative memory occurs when the patient is able to process information and produce specific responses to several stimuli. Anecdotal evidence suggests that children exposed to therapeutic suggestion consisting of gently encouraging, positive words spoken to them during emergence from anesthesia seem to arouse after surgery with less agitation, less pain and lower requirements for pain medications. Therapeutic suggestion has been associated with positive results in some adults during surgery, but it is unknown how therapeutic suggestion affects children. A newborn's recognition and preference for their mother's voice occurs early in life, very likely during fetal development. Additional evidence, revealed that at least as early as 4 months of age, infants process auditory stimuli from their mother's voice at a higher amplitude than they process auditory input from female strangers, suggesting that 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 possibility of intra-operative awareness prevention by using either music listening or maternal sound listening in children undergoing cardiac surgery.

Detailed Description

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children (4 to 8 years) undergoing repair of Atrial Septal Defect (ASD). Patients will be randomized into two groups (music group and maternal sound group); in music group patients listened to a recorded CD by music and songs preferred by the child, 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. In both groups bi spectral index (BIS) to detect depth of anesthesia. An interview will be conducted with the patients and their parent within the first postoperative week by a semi-structured in-depth questionnaire to evaluate occurrence of awareness.

Conditions

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Intraoperative Awareness

Keywords

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Awareness Cardiac Surgery Maternal Pediatric Sound Music

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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Music group

Music sound

Group Type ACTIVE_COMPARATOR

Music sound

Intervention Type BEHAVIORAL

The recorded preferred songs or music (commercially available) listened by CD player connected to the patient ears before induction of anesthesia and continued during intra operative period

Maternal sound group

Maternal sound

Group Type ACTIVE_COMPARATOR

Maternal sound

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

Interventions

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Music sound

The recorded preferred songs or music (commercially available) listened by CD player connected to the patient ears before induction of anesthesia and continued during intra operative period

Intervention Type BEHAVIORAL

Maternal sound

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* patients in the age range 4-8 years scheduled for elective cardiac surgery for Atrial Septal Defect (ASD) repair with Cardiopulmonary bypass

Exclusion Criteria

* Patients with previous cardiac surgery, diabetes mellitus, hearing impairment and psychiatric or neurological illness were excluded from this study.
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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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sayed abd elshafy, MD

Role: PRINCIPAL_INVESTIGATOR

associate professor

Locations

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Faculty of Medicine

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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IRB000087135

Identifier Type: -

Identifier Source: org_study_id