Impact of Intraoperative Music Application on Postoperative Behaviour in Children and Adolescents.
Overview
- Phase
- N/A
- Intervention
- music application
- Conditions
- Postoperative Behaviour
- Sponsor
- University Children's Hospital, Zurich
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Occuring of a behaviour change
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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
Investigators
Eligibility Criteria
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
Arms & Interventions
Music group
music application
Intervention: music application
Music group
music application
Intervention: a caudal block
Control group
only headphones
Intervention: only headphones
Control group
only headphones
Intervention: a caudal block
Outcomes
Primary Outcomes
Occuring of a behaviour change
Time Frame: 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 Outcomes
- occurring of postoperative vomiting(before discharge to the ward, which means after an expected average stay of 2 hours at the recovery room)
- rating of the behaviour of the child in the recovery room by parents using a questionnaire(before discharge to the ward, which means after an expected average stay of 2 hours at the recovery room)
- rating of the behaviour of the child in the recovery room by caretaking personnel using a questionnaire(before discharge to the ward, which means after an expected average stay of 2 hours at the recovery room)