- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02674126
The Efficacy of Maternal Sound for Pediatric Patients Undergoing Cardiac Surgery
4. november 2016 opdateret af: Sayed Kaoud Abd-Elshafy, Assiut University
When Are Parents Helpful? A Randomized Clinical Trial of the Efficacy of Maternal Sound for Pediatric Patients Undergoing Cardiac Surgery
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
106
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Assiut, Egypten
- Faculty of Medicine
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
4 år til 8 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Age range 4-8 years
- Elective cardiac surgery
- Atrial Septal Defect (ASD) repair with Cardiopulmonary bypass
Exclusion Criteria:
- Previous cardiac surgery
- Diabetes mellitus
- Hearing impairment
- Psychiatric illness
- Neurological illness.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Placebo komparator: Kontrolgruppe
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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
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Aktiv komparator: Maternal sound group
Maternal sound
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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
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Blood cortisol level
Tidsramme: Up to 24 hours
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Blood sample will be taken at preoperative, at sternotomy, after 10 minutes of cross clamping during cardiopulmonary bypass, during rewarming and at extubation
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Up to 24 hours
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Blood sugar level
Tidsramme: Up to 24 hours
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Blood sample will be taken at preoperative, at sternotomy, after 10 minutes of cross clamping during cardiopulmonary bypass, during rewarming and at extubation
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Up to 24 hours
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Pain assessment
Tidsramme: Within the first 24 hours
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Pain assessment after extubation by Objective Pain Scale (OPS)
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Within the first 24 hours
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Sedation assessment
Tidsramme: Within the first 24 hours
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Sedation assessment after extubation by Richmond Agitation Sedation Scale (RASS)
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Within the first 24 hours
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Post Traumatic Stress Disorder
Tidsramme: Within the first postoperative week
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An interview conducted with the patients and their parents by researcher blinded to the group randomization within the first postoperative week
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Within the first postoperative week
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Post hospital behavior questionnaire
Tidsramme: Within the first postoperative week
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An interview conducted with the patients and their parents by researcher blinded to the group randomization within the first postoperative week
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Within the first postoperative week
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: sayed abd elshafy, Associate Professor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2016
Primær færdiggørelse (Faktiske)
1. september 2016
Studieafslutning (Faktiske)
1. september 2016
Datoer for studieregistrering
Først indsendt
31. januar 2016
Først indsendt, der opfyldte QC-kriterier
2. februar 2016
Først opslået (Skøn)
4. februar 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
8. november 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. november 2016
Sidst verificeret
1. november 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- IRB000087350
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Uafklaret
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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