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

18. oktober 2017 oppdatert 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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

309

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Assiut, Egypt
        • Faculty of Medicine

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

4 år til 8 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Intraoperative awareness
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Duration of mechanical ventilation
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Within the first 7 days postoperative
changes in physiological and psychosocial behaviors of children by questionnaire
Within the first 7 days postoperative

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: sayed abd elshafy, MD, Associate Professor

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. juni 2016

Primær fullføring (Faktiske)

1. september 2017

Studiet fullført (Faktiske)

1. september 2017

Datoer for studieregistrering

Først innsendt

10. oktober 2015

Først innsendt som oppfylte QC-kriteriene

20. oktober 2015

Først lagt ut (Anslag)

22. oktober 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. oktober 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. oktober 2017

Sist bekreftet

1. oktober 2017

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • IRB000087135

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Intraoperativ bevissthet

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