Trials / Completed
CompletedNCT02674126
The Efficacy of Maternal Sound for Pediatric Patients Undergoing Cardiac Surgery
When Are Parents Helpful? A Randomized Clinical Trial of the Efficacy of Maternal Sound for Pediatric Patients Undergoing Cardiac Surgery
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 106 (actual)
- Sponsor
- Assiut University · Academic / Other
- Sex
- All
- Age
- 4 Years – 8 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
| BEHAVIORAL | 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 |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2016-09-01
- Completion
- 2016-09-01
- First posted
- 2016-02-04
- Last updated
- 2016-11-08
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT02674126. Inclusion in this directory is not an endorsement.