NCT02339298

Intraoperative Music Application and Postoperative Behaviour in Children and Adolescents.

Impact of Intraoperative Music Application on Postoperative Behaviour in Children and Adolescents.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: University Children's Hospital, Zurich · Academic / Other
• Sex: All
• Age: 4 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate whether intraoperative music application has a positive impact on postoperative behavior in children and adolescents.

Detailed description

After induction of anesthesia, paralyzation of the patient and subsequent intubation, a caudal block is applied. After positioning of the patient, headphones are placed on the patients head and in case of the interventional group, music is played. Previously, the volume of the music is adjusted to a range from 50 to 60 decibel. Headphones are removed before extubation. Postoperative behaviour is evaluated by parents and by caretaking personnel in the recovery room at arrival, after 15 minutes and before discharge to the ward and at home by parents after one, two and four weeks using questionnaires. sample size calculation: n = minimal number of required probands π = 70% (proportion of interest) → 0.7 π0 = 50% (null hypothesis proportion) → 0.5 μ = (100% - 90%power) → 1.28 v = 1.96 (level of significance p=0.05) n \> \[ μ√ π(1- π) + v√ π0(1- π0)\]2 / (π - π0) n \> 61.4 + correction for drop-outs (+10%) n = 70 per group → 140 probands in total

Conditions

• Postoperative Behaviour

Interventions

Type	Name	Description
OTHER	music application	music is applied during anaesthesia using headphones
OTHER	only headphones	music is not applied, only headphones are placed
DRUG	a caudal block

Timeline

• Start date: 2009-07-01
• Primary completion: 2015-10-01
• Completion: 2015-11-01
• First posted: 2015-01-15
• Last updated: 2015-11-10

Locations

1 site across 1 country: Switzerland