hypospadia or defect in opening of penis inguinal hernia or groin hernia orchidopexy or undescended testicle
Conditions
Interventions
Patients will be allocated to one of three study arms. The patients in the
first study arm will receive both pre-operative and intraoperative music
intervention
the patients in the second study arm will only receive
preoperative music intervention
the patients in the third study arm will
receive no intervention and serve as control group. All subjects will wear
headphones during surgery. Subjects will listen to an appropriate music
intervent
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: - Age 0-3 years (inclusively 3 years) - 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 |
|---|---|
| The main study outcome is distress intensity assessed with the Comfort-B scale. Preoperative anxiety at induction and physiological parameters such as blood pressure are secondary outcome parameters to assess physiological stress. Also, the amount of postoperative pain and possible relation of distress in children regarding to distress in their parents are secondary parameters. | — |
Secondary
| Measure | Time frame |
|---|---|
| The use of music as intervention has no known deleterious effects on patients. Safety precautions will be taken to limit the volume of the music on headphones. Patients in all study arms will receive standard perioperative care. Burden includes the completion of several questionnaires and two measurements of heart rate by parents. Measurements of vital signs will be collected from normal care data. No extra site visits will be necessary for participation in this study. This research is performed in minors, as the additive value of this intervention in these age groups has not been sufficiently studied. | — |
Countries
Netherlands
Outcome results
None listed