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

NCT02583295 | Completed DMC

• 1 other identifier: IRB000087135
• Study Type: interventional
• Target: 309
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intraoperative Awareness

Keywords

Awareness; Cardiac Surgery; Maternal; Pediatric; Sound; Music

Outcome Measures

Primary Outcomes (1)

• Intraoperative awareness

  by using a semi-structured in-depth questionnaire (a qualitative method adapted to assess memory development and language level in children to encourage their recall quality and reduce their suggestibility)

  within the first 24 hours during surgery

Secondary Outcomes (7)

• Duration of mechanical ventilation

  within the first 30 days after surgery

• postoperative cardiac ICU stay

  within the first 30 days after surgery

• hospital stay

  within the first 30 days after surgery

• changes from baseline serum cortisol at postoperative period

  Within the first 7 days postoperative

• changes from baseline blood sugar at postoperative period

  Within the first 7 days postoperative

Study Arms (2)

Music group

ACTIVE COMPARATOR

Music sound

Behavioral: Music sound

Maternal sound group

ACTIVE COMPARATOR

Maternal sound

Behavioral: Maternal sound

Interventions

Music sound 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

Music group

Maternal sound 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

Maternal sound group

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine

Asyut, Egypt

Location

MeSH Terms

Conditions

Intraoperative Awareness

Condition Hierarchy (Ancestors)

Intraoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• sayed abd elshafy, MD

  associate professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• 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

Study Record Dates

• First Submitted: October 10, 2015
• First Posted: October 22, 2015
• Study Start: June 15, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 19, 2017

Record last verified: 2017-10

Locations

EG (1)