The Efficacy of Maternal Sound for Pediatric Patients Undergoing Cardiac Surgery

Maternal-Fetal Relations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02674126
• Other study ID #: IRB000087350
• Status: Completed
• Phase: Phase 2
• First received: January 31, 2016
• Last updated: November 4, 2016
• Start date: January 2016
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 8 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Maternal-Fetal Relations

Intervention

Behavioral:
• 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
• 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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	Pain assessment	Pain assessment after extubation by Objective Pain Scale (OPS)	Within the first 24 hours	Yes
Secondary	Sedation assessment	Sedation assessment after extubation by Richmond Agitation Sedation Scale (RASS)	Within the first 24 hours	Yes
Secondary	Post Traumatic Stress Disorder	An interview conducted with the patients and their parents by researcher blinded to the group randomization within the first postoperative week	Within the first postoperative week	Yes
Secondary	Post hospital behavior questionnaire	An interview conducted with the patients and their parents by researcher blinded to the group randomization within the first postoperative week	Within the first postoperative week	Yes