Periprocedural anxiety in children and accompanying caregivers amidst surgery or invasive medical procedures.
Conditions
Interventions
Group 1: Intervention group, pediatric patient and accompanying caregiver receive music-tablet-app MuMa as study intervention before surgery or invasive medical intervention.
Use of the app is volun
these are additionally documented.
Group 2: Control group, pediatric patient and accompanying caregiver don't receive music-tablet-app MuMa, but only standard of care treatment (including application
these are additionally documented.
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
3 Years to 10 Years
Inclusion criteria
Inclusion criteria: Elective surgery or elective invasive procedure of the child patient at Heidelberg University Hospital. Voluntary consent to study participation. Legal age of the caregiver (usually parent).
Exclusion criteria
Exclusion criteria: Children before completion of third year of age or after completion of 11th year of age at time of assessment. Caregiver not of legal age. Higher degree of audiovisual or cognitive impairment of the study participants. Severely limited german language skills among study participants. Emergency intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim is to investigate whether an intervention with a music tablet app relevantly reduces children's and parents' anxiety before performing a medical procedure. The primary endpoint is therefore the change in anxiety level in children using the well-validated observational score mYPAS (modified Yale Perioperative Anxiety Score). The observation period between the two mYPAS measurements will be approximately 30 minutes and will occur before surgery or invasive medical procedures are performed. On the caregiver side, the primary endpoint is the anxiety level of the accompanying caregiver measured in parallel over the same time course using a well-validated questionnaire (State Trait Anxiety Inventory Y6). Thereby, the dynamics of anxiety levels in children and parents can be traced over the course of the intervention or control period. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints examine whether the music intervention achieves an improvement in child heart rate variability (HRV), which is measured throughout the study day using chest sensors. This somatic endpoint to measure anxiety complements the primary endpoint absed on the psychological testing instrument, mYPAS. Beyond the anxiety level, we will investigate whether the anxiety-reducing strategy can lead to an improvement in the child's willingness to cooperate during the anesthesiological induction. This will be measured using a well-validated observation score during anesthesia/sedation induction (Induction Compliance Catalogue). Stress reactions during the recovery phase after surgery will be measured by another well validated observation score (Excitement Score). Last, delayed anxiety reactions will be assessed using the well-validated Post Hospitalization Behavior Questionnaire (PHBQ-AS) at 10 days, 4 weeks, and 3 months via email and telephone. | — |
Countries
Germany
Contacts
Public ContactRoland Imle
Universitätklinikum Heidelberg
Outcome results
None listed