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

Intraoperative Awareness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02583295
• Other study ID #: IRB000087135
• Status: Completed
• Phase: N/A
• First received: October 10, 2015
• Last updated: October 18, 2017
• Start date: June 15, 2016
• Est. completion date: September 2017

Study information

• Verified date: October 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intraoperative Awareness

Intervention

Behavioral:
• 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
• 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

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	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	Duration of mechanical ventilation	duration of postoperative mechanical ventilation reported in hours	within the first 30 days after surgery
Secondary	postoperative cardiac ICU stay	length of stay in the postoperative cardiac ICU (days)	within the first 30 days after surgery
Secondary	hospital stay	length of stay in the hospital (days)	within the first 30 days after surgery
Secondary	changes from baseline serum cortisol at postoperative period	changes from baseline serum cortisol at postoperative period	Within the first 7 days postoperative
Secondary	changes from baseline blood sugar at postoperative period	changes from baseline blood sugar at postoperative period	Within the first 7 days postoperative
Secondary	child post-traumatic stress disorder (PTSD)	child post-traumatic stress disorder (PTSD) by special scale questionnaire	Within the first 7 days postoperative
Secondary	changes in behavior	changes in physiological and psychosocial behaviors of children by questionnaire	Within the first 7 days postoperative