Music Interventions in Pediatric Surgery (The Music Under Surgery In Children Study): A Randomized Clinical Trial
Kühlmann AYR, van Rosmalen J, Staals LM, Keyzer-Dekker CMG, Dogger J, de Leeuw TG, van der Toorn F, Jeekel J, Wijnen RMH, van Dijk M
Anesthesia and analgesia · 31 citas
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2019-01-15 · Anesth Analg · vol. 130 · número 4 · págs. 991–1001
- Editorial
- Lippincott Williams & Wilkins
- Citado
- 56 citas · más que el 95% de estudios similares · 5.3× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 41 trabajos
- Acceso
- De pago
- Áreas de investigación
- Music Therapy and Health · Pediatric Pain Management Techniques · Infant Development and Preterm Care
- Palabras clave
- Medicine, Randomized controlled trial, Anxiety, Perioperative, Psychological intervention, Interquartile range, Distress, Observational study, Music therapy, Physical therapy, FLACC scale, Anesthesia, Surgery, Internal medicine
- MeSH
- humans, treatment outcome, music therapy, intraoperative care, preoperative care, anesthesia, single-blind method, child behavior, anxiety, blood pressure, heart rate, child, preschool, infant, female, male, patient comfort
10 autores
- A. Y. Rosalie Kühlmann🇳🇱 · autor de correspondenciaErasmus MC
- Joost van Rosmalen🇳🇱Erasmus MC
- Lonneke M. Staals
- Claudia M. G. Keyzer‐Dekker🇳🇱 · autor de correspondenciaErasmus MC
- Jaap Dogger
- Thomas G. de Leeuw
- Fred van der Toorn🇳🇱Erasmus MC
- J Jeekel
- Rene M. H. Wijnen🇳🇱 · autor de correspondenciaErasmus MC
- Monique van Dijk🇳🇱 · autor de correspondenciaErasmus MC
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Perioperative music interventions have been shown to reduce anxiety and pain in adults. This inexpensive, easily applicable intervention could be of benefit to children as well. Our objective was to determine the effects of music interventions on distress, anxiety, and postoperative pain in infants undergoing surgery.
Methods
The Music Under Surgery In Children study was designed as a parallel, single-blind, randomized controlled trial with an a priori formulated hypothesis. Data were collected between August 2015 and October 2016 in a single tertiary care children's hospital. There was a 24-hour follow-up with blind primary outcome assessment. A random sample of 432 eligible 0-3 years of age infants admitted for orchidopexy, hypospadias, or inguinal hernia repair receiving general anesthesia and caudal block were asked for participation. Subjects were assigned to a preoperative music intervention, pre- and intraoperative music intervention, or no music intervention (control) via random allocation using a computer-generated list with the use of opaque envelopes. The main outcome measure was the postoperative level of distress assessed with the COMFORT-Behavior scale, which is an observational scale; furthermore, preoperative level of distress, preoperative anxiety, and physiological measurements such as heart rate (HR) and blood pressure were measured. The trial was registered at the Dutch Trial Register, number NTR5402 (www.trialregister.nl).
Results
One hundred ninety-five infants with median age 6.9 months (interquartile range, 3.3-11.1) were randomized, 178 of whom were included in the primary analysis. A nonsignificant difference in COMFORT-Behavior scale scores between the pre- and intraoperative music intervention group and control group at 4 hours after surgery was found (mean difference, -1.22; 95% CI, 2.60-0.17; P = .085). Additional analysis showed weak nonsignificant evidence for an interaction effect between music exposure and COMFORT-Behavior score at baseline (P = .027 with a Bonferroni-adjusted significance level of .025). General linear modeling showed a statistically significantly reduced HR after the preoperative music intervention in the holding area in the combined preoperative music intervention and intraoperative music intervention group compared to the control group (P = .003). The differences in HR among the 3 study arms at all time points were not statistically significant (P = .069).
Conclusions
Music interventions do not seem to benefit all young infants undergoing surgery. The potential benefits of music interventions in the preoperative period and in more distressed children warrant further exploration.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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