A randomized-controlled trial investigating the effects of a magic-based intervention in children undergoing catheter-based ablation.

Conditions: Cardiac arrhythmias
10007521

Registration Number: NL-OMON53192

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

In order to be eligible to participate in this study, the child must meet all
of the following criteria:
• Between 7-18 years of age
• Undergoing catheter-based ablation at WAKZ
• Sufficient understanding of written and spoken Dutch
• Consent to participate in the study by (all) legal guardians in children < 16
years of age

One parent/caregiver per child is eligible for inclusion if they meet all three
criteria:
• Is planning to be present with the child during the catheter-based ablation
and the hospital stay
• Has sufficient understanding of written and spoken Dutch
• The other parent/caregiver (if applicable) does not participate in our study

Healthcare professionals of all disciplines are eligible for inclusion if they
meet both criteria:
• Employed at WAKZ/LUMC
• Directly involved in the care of children undergoing catheter-based ablation

Exclusion Criteria

A child who lacks the necessary skills to report its own thoughts and emotions
due to cognitive impairment will be excluded from participating in this study.

In addition, children using corticosteroids (i.e. for asthma) or using oral
contraceptive pills, will be excluded from participation in this study as these
substances may blunt the cortisol stress response.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the childs self-reported distress during the three<br /><br>time points on the day of the cardiac ablation (directly before the procedure,<br /><br>after the procedure before the magic training, and after the magic training).<br /><br>We will investigate whether this overall* self-reported distress of the three<br /><br>time points is successfully reduced in the magic-based intervention group<br /><br>compared to the control group. </p><br>

Secondary Outcome Measures