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Completed

NCT Number: NCT02583295

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

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.

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Key information

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. Intraoperative awareness

    Time frame: within the first 24 hours during surgery

    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 outcomes

  1. Duration of mechanical ventilation

    Time frame: within the first 30 days after surgery

    duration of postoperative mechanical ventilation reported in hours

  2. postoperative cardiac ICU stay

    Time frame: within the first 30 days after surgery

    length of stay in the postoperative cardiac ICU (days)

  3. hospital stay

    Time frame: within the first 30 days after surgery

    length of stay in the hospital (days)

  4. changes from baseline serum cortisol at postoperative period

    Time frame: Within the first 7 days postoperative

    changes from baseline serum cortisol at postoperative period

  5. changes from baseline blood sugar at postoperative period

    Time frame: Within the first 7 days postoperative

    changes from baseline blood sugar at postoperative period

  6. child post-traumatic stress disorder (PTSD)

    Time frame: Within the first 7 days postoperative

    child post-traumatic stress disorder (PTSD) by special scale questionnaire

  7. changes in behavior

    Time frame: Within the first 7 days postoperative

    changes in physiological and psychosocial behaviors of children by questionnaire

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 22, 2015
Registry last updated
Oct 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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