music intervention, preoperative anxiety, postoperative pain, parental anxiety.
Conditions
Interventions
Patient 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, rec
Sponsors
Sophia Kinderziekenhuis Rotterdam
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| distress intensity assessed with the COMFORT behavior scale at t=1,t=2, t=4,t=5, t=6, t=7 | — |
Secondary
| Measure | Time frame |
|---|---|
| salivary 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 | — |
Contacts
Public ContactRosalie Kühlmann
Erasmus MC
Outcome results
None listed