No registrations found.
ID
Source
Brief title
Health condition
music intervention, preoperative anxiety, postoperative pain, parental anxiety.
Sponsors and support
Intervention
Outcome measures
Primary outcome
distress intensity assessed with the COMFORT behavior scale at t=1,t=2, t=4,t=5, t=6, t=7
Secondary outcome
salivary cortisol at t=1, t=3, t=4
heart rate at t=0, t=1, t=2, t=5, t=6, t=7
blood pressure at t=0, t=1, t=2, t=5, t=6, t=7
heart rate, blood pressure, saturation during anesthesia and surgery at t=3 and t=4
observed pain at t=1,t=2, t=4,t=5, t=6, t=7
use of medication at t=1 t/m t=7
parental anxiety at t=0, t=2
parental heart rate at t=0, t=2
parental anxiety and need for information at t=1
Background summary
This study will investigate the effects of a music intervention on distress, anxiety and pain in pediatric surgery. Surgical procedures are accompanied by high levels of distress and pain in the adult as well as the pediatric population. Studies in adult populations found that music interventions prior to and during surgery can alleviate anxiety and distress surrounding surgery and postoperative pain. In this study, we will investigate the hypothesis that music interventions prior to and during surgery will result in less anxiety and distress in infants undergoing surgical procedures.
The research will take place in children in the age of 0-3 years who will have surgery for inguinal hernia, undescended testicle or hypospadias.
This study will be performed as a single-blinded randomized controlled intervention study. Patients will be allocated to one of three study arms, resulting in two, one or no music interventions. Music interventions are administered by headphone. Subjects will listen to an appropriate music intervention, as reported in literature and recommended by music therapists.
The effect of the music intervention will be monitored during the first 24 hours after surgery. All patients will be recruited in The Netherlands.
Study objective
Surgical procedures are accompanied by high levels of distress and pain in the adult as well as the pediatric population. Music interventions have shown to reduce this anxiety and pain in adult populations. In this study, we will investigate the hypothesis that music interventions prior to and during surgery will result in less anxiety, distress and pain in infants undergoing surgical procedures.
Study design
t=0 outpatient clinic
t=1 ward
t=2 holding area
t=3 start of surgery
t=4 end of surgery
t=5 30 minutes postoperatively
t=6 4 hours postoperatively
t=7 24 hours postoperatively
Intervention
Patient randomly allocated to one of three intervention groups:
1. music intervention prior to and during surgery
2. music intervention prior to surgery
3. control group, no music intervention, receives standard care.
Patients in group 1 and 2 receive music intervention by headphone for approximately 15 minutes prior to surgery, patients in group 3 receive standard care. During surgery, all patients receive headphones, but only patients in group 1 will have a music intervention.
Rosalie Kühlmann
s-Gravendijkwal 230, room Z-523
Rotterdam 3015 CE
The Netherlands
0031-10-7038736
a.kuhlmann@erasmusmc.nl
Rosalie Kühlmann
s-Gravendijkwal 230, room Z-523
Rotterdam 3015 CE
The Netherlands
0031-10-7038736
a.kuhlmann@erasmusmc.nl
Inclusion criteria
-Age 0-3 years (inclusively 3 years), both male and female
-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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5293 |
| NTR-old | NTR5402 |
| Other | METC Erasmus MC Rotterdam : MEC 2015-264 NL53900.078.15 |