Evaluating quality of life and stigmatization in children with congenital melanocytic nevi before and after surgery
Quality of Life and Experience of Stigmatization in Children With Congenital Melanocytic Nevi Before and After Nevus Excision: a Prospective Study
This study looks at how surgery for congenital melanocytic nevi affects the quality of life and feelings of being judged in children before and after the operation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 9 Months to 16 Years |
| Sex | All |
| Sponsor | University Children's Hospital, Zurich Academic / other |
| Locations | 1 site (Zurich) |
| Trial ID | NCT02280889 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on children with congenital melanocytic nevi (CMN) who are scheduled for surgical excision. Participants will complete questionnaires assessing their quality of life and experiences of stigmatization before the surgery and again one year post-operation. The study aims to gather both self-reports from the children and proxy reports from their parents to evaluate the psychological and aesthetic impacts of the nevus and its removal. The findings will help to understand the necessity of surgical intervention from both medical and psychosocial perspectives.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 9 months to 16 years with congenital melanocytic nevi measuring at least 2 cm² who are undergoing surgical removal.
Not a fit: Patients with mental retardation, severe comorbidities, or those who have previously undergone treatments for CMN may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the psychological benefits of nevus excision, improving the quality of life for affected children.
How similar studies have performed: While there is limited data on similar studies, the approach of evaluating quality of life and stigmatization in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients with a congenital melanocytic nevi of at least 2 cm2 that will be removed surgically * age between 9 months and 16 years Exclusion Criteria: * mental retardation of the child * insufficient knowledge of the German language of both parents * severe comorbidities * previous therapies done for the CMN (dermabrasion, surgery, laser)
Where this trial is running
Zurich
- University Children's Hospital Zurich, Division of Pediatric Plastic and reconstructive Surgery — Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Kathrin Neuhaus, MD — University Children's Hospital, Zurich
- Study coordinator: Kathrin Neuhaus, MD
- Email: kathrin.neuhaus@kispi.uzh.ch
- Phone: +41442497466
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.