跳至主要内容
临床试验/NCT06934759
NCT06934759Enrolling By Invitation不适用

Impact and Lived Experience of Parents of a Child With a Large or Giant Congenital Melanocytic Nevus (PANGEA Study) : A National Qualitative Study

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
30
试验地点
1
主要终点
Results of the Semi-Structured Interviews with Parents

研究概览

简要总结

The goal of this observational study is to describe the experiences of parents at the birth of a child with a large or giant congenital melanocytic nevus through semi-structured interviews, and to identify potential intervention strategies to improve their care and support.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 years or older
  • Willing to participate in a semi-structured interview
  • Has received full information about the research and has not objected to participating or to the use of their data
  • Able to understand and speak French
  • Parent of a child under 18 years of age

排除标准

  • Under 18 years of age
  • Not willing to participate
  • Currently under legal protection (e.g., guardianship or curatorship)
  • Cognitive and/or psychological impairments preventing participation in a semi-structured interview
  • Poor understanding and/or expression of the French language
  • Parent of a child over 18 years of age

结局指标

主要结局

Results of the Semi-Structured Interviews with Parents

时间窗: Socio-demographic data and interview transcripts will be collected during the semi-structured interviews (lasting between 30 minutes and 1 hour), thus at a single time point (Day 1). No follow-up is required.

Analysis of the interview transcripts = verbatim analysis Individual semi-structured interviews will be conducted via videoconference, with an estimated duration of 30 minutes to 1 hour. An interview guide has been developed to define the key dimensions to be explored. Each interview will be audio-recorded using a voice recorder and then fully transcribed. The interviews will undergo a thematic content analysis to identify meaningful patterns ("nodes of meaning") within participants' narratives, using an inductive approach. A double coding will be performed by two investigators on five interviews to strengthen the thematic framework. The remaining interviews will be coded by a single investigator

次要结局

未报告次要终点

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne Claire BURSZTEJN

Clinical Professor and Principal Investigator

Central Hospital, Nancy, France

研究点 (1)

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