Music Under Surgery In Childre

Recruiting

Conditions: hypospadia or defect in opening of penis
inguinal hernia or groin hernia
orchidopexy or undescended testicle
10013355
10040795

Registration Number: NL-OMON43650

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 195

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

- 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study outcome is distress intensity assessed with the Comfort-B scale.<br /><br>Preoperative anxiety at induction and physiological parameters such as blood<br /><br>pressure are secondary outcome parameters to assess physiological stress. Also,<br /><br>the amount of postoperative pain and possible relation of distress in children<br /><br>regarding to distress in their parents are secondary parameters.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The use of music as intervention has no known deleterious effects on patients.<br /><br>Safety precautions will be taken to limit the volume of the music on<br /><br>headphones. Patients in all study arms will receive standard perioperative<br /><br>care. Burden includes the completion of several questionnaires and two<br /><br>measurements of heart rate by parents. Measurements of vital signs will be<br /><br>collected from normal care data. No extra site visits will be necessary for<br /><br>participation in this study. This research is performed in minors, as the<br /><br>additive value of this intervention in these age groups has not been<br /><br>sufficiently studied. </p><br>