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Music Under Surgery In Children


- candidate number22799
- NTR NumberNTR5402
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-aug-2015
- Secondary IDsMEC 2015-264 NL53900.078.15 METC Erasmus MC Rotterdam
- Public TitleMusic Under Surgery In Children
- Scientific TitleMusic Under Surgery In Children
- ACRONYMMUSIC
- hypothesisSurgical procedures are accompanied by high levels of distress and pain in the adult as well as the pediatric population. Music interventions have shown to reduce this anxiety and pain in adult populations. In this study, we will investigate the hypothesis that music interventions prior to and during surgery will result in less anxiety, distress and pain in infants undergoing surgical procedures.
- Healt Condition(s) or Problem(s) studiedPreoperative anxiety, Post-operative pain, Music intervention
- Inclusion criteria-Age 0-3 years (inclusively 3 years), both male and female
-Scheduled for surgery for inguinal hernia (uni- or bilateral), undescended testicle (uni- or bilateral), hypospadias
-American Society of Anesthesiologists (ASA) physical status 1 and 2
-General anaesthesia with caudal block
-Parents good knowledge of the Dutch or English language
-Signed informed consent
- Exclusion criteria-Age ≥ 4 years
-Hearing impairments
-Emergency surgery
-Premedication with midazolam
-Impaired communication with parents
-Difficulties in speaking and reading Dutch or English in parents
-Missing informed consent
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 27-aug-2015
- planned closingdate31-dec-2016
- Target number of participants195
- InterventionsPatient randomly allocated to one of three intervention groups:
1. music intervention prior to and during surgery
2. music intervention prior to surgery
3. control group, no music intervention, receives standard care.
Patients in group 1 and 2 receive music intervention by headphone for approximately 15 minutes prior to surgery, patients in group 3 receive standard care. During surgery, all patients receive headphones, but only patients in group 1 will have a music intervention.
- Primary outcomedistress intensity assessed with the COMFORT behavior scale at t=1,t=2, t=4,t=5, t=6, t=7
- Secondary outcomesalivary cortisol at t=1, t=3, t=4
heart rate at t=0, t=1, t=2, t=5, t=6, t=7
blood pressure at t=0, t=1, t=2, t=5, t=6, t=7
heart rate, blood pressure, saturation during anesthesia and surgery at t=3 and t=4
observed pain at t=1,t=2, t=4,t=5, t=6, t=7
use of medication at t=1 t/m t=7
parental anxiety at t=0, t=2
parental heart rate at t=0, t=2
parental anxiety and need for information at t=1
- Timepointst=0 outpatient clinic
t=1 ward
t=2 holding area
t=3 start of surgery
t=4 end of surgery
t=5 30 minutes postoperatively
t=6 4 hours postoperatively
t=7 24 hours postoperatively
- Trial web site
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES Rosalie Kühlmann
- CONTACT for SCIENTIFIC QUERIESProf. Dr. R.M.H. Wijnen
- Sponsor/Initiator Erasmus Medical Center, Sophia Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
Stichting Swart van Essen, WM de Hoop Stichting, Dokter Izak Wessel Stichting
- Publications
- Brief summaryThis study will investigate the effects of a music intervention on distress, anxiety and pain in pediatric surgery. Surgical procedures are accompanied by high levels of distress and pain in the adult as well as the pediatric population. Studies in adult populations found that music interventions prior to and during surgery can alleviate anxiety and distress surrounding surgery and postoperative pain. In this study, we will investigate the hypothesis that music interventions prior to and during surgery will result in less anxiety and distress in infants undergoing surgical procedures.
The research will take place in children in the age of 0-3 years who will have surgery for inguinal hernia, undescended testicle or hypospadias.
This study will be performed as a single-blinded randomized controlled intervention study. Patients will be allocated to one of three study arms, resulting in two, one or no music interventions. Music interventions are administered by headphone. Subjects will listen to an appropriate music intervention, as reported in literature and recommended by music therapists.
The effect of the music intervention will be monitored during the first 24 hours after surgery. All patients will be recruited in The Netherlands.
- Main changes (audit trail)
- RECORD26-aug-2015 - 7-feb-2017


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