Music Therapy: An Adjunct To Gastroschisis Infants' Care (MAGIC)
The Effect of Music Therapy On Infants Born With Gastroschisis
The investigators hope to determine if music therapy will have beneficial effects on physiologic parameters, behavioral states, and pain scale evaluations in infants with gastroschisis defects and if music therapy promotes parental/caregiver relaxation and demonstrates to the parent/caregiver that music is an effective tool to calm and soothe their infant at risk for chronic gastrointestinal discomfort.
Babies will be enrolled during the perinatal period, with therapy to begin after surgical repair of the gastroschisis defect and when the neonatologist deems the baby stable enough for music therapy intervention. Enrolled subjects may receive up to 3 music therapy sessions/week and these sessions may continue until discharge. There is no follow up after discharge.
Each one hour session (20-30 minutes of music and 30 minutes of quiet) will include:
- Pre music therapy behavior state will be assessed using CRIES scale and recorded.
- Five minutes of baseline vital signs will be recorded.
- Music therapy lasting 20-30 minutes, will start. Music therapist will use guitar and lap harp to perform live lullaby tupe music with or with out vocals. Decibel levels will be maintained at 65-75dB. Session will stop if infant shows any signs of distress/agitation. Vital signs will be collected every 1-4 minutes during music session.
- After session behavior state using CRIES scale will be recorded.
- Family/caregiver will be given a questionnaire to fill out.
- 30 min of quiet will start.
- At the end of quiet time, behavior state and vital signs will be recorded for the last time.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Prior to starting the music therapy session, family/caregivers, if present, will be informed of study session progression. They will be reminded of appropriate behavioral protocol to maintain therapeutic environment during session - i.e. minimal taking & touching, cell phones off etc. A "Do Not Disturb - Music Therapy Session in Progress" will be posted outside pts room on the door.
Behavioral state data and vitals signs collected during sessions will be entered into a database. Also recorded, will be general information about the baby and its mother, such as, gestational age, apgar scores, mothers age and race, number of days post surgical repair etc.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55404
- Recrutement
- Childrens Hospitals and Clinics of MN
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Contact:
- Catherine T Worwa
- Numéro de téléphone: 612-813-6864
- E-mail: cathy.worwa@childrensmn.org
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Chercheur principal:
- Ellen Bendel-Stenzel, MD
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Sous-enquêteur:
- Melissa Wenszell, MT-BC, NMT
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Diagnosis of Gastroschisis
- Patient is stable enough to receive music therapy as determined by Neonatologist
- Patient has passed their newborn hearing screen
Exclusion Criteria:
1. Neonatologist feels patient/family would not be an acceptable research candidate.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Music Therapy will produce stable physiologic, states as well as, positive behavior states
Délai: 3 years
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Vital signs monitor data and stress assessment scores will be collected before, during and post Music Therapy sessions
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3 years
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1110096A
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