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

18 oktober 2017 uppdaterad av: Sayed Kaoud Abd-Elshafy, Assiut University
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.

Studieöversikt

Status

Avslutad

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

309

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Assiut, Egypten
        • Faculty of Medicine

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

4 år till 8 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Maternal sound group
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
Aktiv komparator: Music group
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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Intraoperative awareness
Tidsram: 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)
within the first 24 hours during surgery

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: sayed abd elshafy, MD, Associate Professor

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

15 juni 2016

Primärt slutförande (Faktisk)

1 september 2017

Avslutad studie (Faktisk)

1 september 2017

Studieregistreringsdatum

Först inskickad

10 oktober 2015

Först inskickad som uppfyllde QC-kriterierna

20 oktober 2015

Första postat (Uppskatta)

22 oktober 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

19 oktober 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

18 oktober 2017

Senast verifierad

1 oktober 2017

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • IRB000087135

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

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Kliniska prövningar på Intraoperativ medvetenhet

Kliniska prövningar på Music sound

3
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