Postoperative Behaviour
Conditions
Keywords
Music Therapy
Brief 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
Interventions
OTHERmusic application
music is applied during anaesthesia using headphones
OTHERonly headphones
music is not applied, only headphones are placed
DRUGa caudal block
Sponsors
University Children's Hospital, Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
4 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* age: 4-16 years * American Society of Anesthesiologists (ASA) physical status of 1 and 2 * elective inguinal herniotomy or circumcision * general anaesthesia with sevoflurane and caudal block * written informed consent available
Exclusion criteria
* age \<4 or \>16.99 years * ASA physical status of 3 or higher * emergency surgery * no general anaesthesia with sevoflurane or/and caudal block * no written informed consent available
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occuring of a behaviour change | patients are followed during the first 4 weeks after the operation | Patients are followed during the first 4 weeks after the operation by parents using a questionnaire in order to detect behaviour changes after the operation. |
Secondary
| Measure | Time frame |
|---|---|
| occurring of postoperative vomiting | baseline |
| rating of the behaviour of the child in the recovery room by parents using a questionnaire | baseline |
| rating of the behaviour of the child in the recovery room by caretaking personnel using a questionnaire | baseline |
Countries
Switzerland
Outcome results
None listed