The Impact of Maternal Sound on Awareness for Pediatric Patients Undergoing Cardiac Surgery
Primary Purpose
Intraoperative Awareness
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Music sound
Maternal sound
Sponsored by
About this trial
This is an interventional prevention trial for Intraoperative Awareness focused on measuring Awareness, Cardiac Surgery, Maternal, Pediatric, Sound, Music
Eligibility Criteria
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.
Sites / Locations
- Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Music group
Maternal sound group
Arm Description
Music sound
Maternal sound
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Duration of mechanical ventilation
duration of postoperative mechanical ventilation reported in hours
postoperative cardiac ICU stay
length of stay in the postoperative cardiac ICU (days)
hospital stay
length of stay in the hospital (days)
changes from baseline serum cortisol at postoperative period
changes from baseline serum cortisol at postoperative period
changes from baseline blood sugar at postoperative period
changes from baseline blood sugar at postoperative period
child post-traumatic stress disorder (PTSD)
child post-traumatic stress disorder (PTSD) by special scale questionnaire
changes in behavior
changes in physiological and psychosocial behaviors of children by questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02583295
Brief Title
The Impact of Maternal Sound on Awareness for Pediatric Patients Undergoing Cardiac Surgery
Official Title
The Impact of Maternal Sound on Awareness for Pediatric Patients Undergoing Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 15, 2016 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraoperative Awareness
Keywords
Awareness, Cardiac Surgery, Maternal, Pediatric, Sound, Music
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
309 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Music group
Arm Type
Active Comparator
Arm Description
Music sound
Arm Title
Maternal sound group
Arm Type
Active Comparator
Arm Description
Maternal sound
Intervention Type
Behavioral
Intervention Name(s)
Music sound
Intervention Description
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
Intervention Name(s)
Maternal sound
Intervention Description
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
Primary Outcome Measure Information:
Title
Intraoperative awareness
Description
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)
Time Frame
within the first 24 hours during surgery
Secondary Outcome Measure Information:
Title
Duration of mechanical ventilation
Description
duration of postoperative mechanical ventilation reported in hours
Time Frame
within the first 30 days after surgery
Title
postoperative cardiac ICU stay
Description
length of stay in the postoperative cardiac ICU (days)
Time Frame
within the first 30 days after surgery
Title
hospital stay
Description
length of stay in the hospital (days)
Time Frame
within the first 30 days after surgery
Title
changes from baseline serum cortisol at postoperative period
Description
changes from baseline serum cortisol at postoperative period
Time Frame
Within the first 7 days postoperative
Title
changes from baseline blood sugar at postoperative period
Description
changes from baseline blood sugar at postoperative period
Time Frame
Within the first 7 days postoperative
Title
child post-traumatic stress disorder (PTSD)
Description
child post-traumatic stress disorder (PTSD) by special scale questionnaire
Time Frame
Within the first 7 days postoperative
Title
changes in behavior
Description
changes in physiological and psychosocial behaviors of children by questionnaire
Time Frame
Within the first 7 days postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sayed abd elshafy, MD
Organizational Affiliation
associate professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Impact of Maternal Sound on Awareness for Pediatric Patients Undergoing Cardiac Surgery
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