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Children's self reported discomforts as participants in clinical research
Mira S Staphorst1, Joke A M Hunfeld1, Suzanne van de Vathorst2
1Department of Psychiatry, Section Medical Psychology and Psychotherapy, Erasmus University Medical Center, PO Box 2040, 3000 CA, Rotterdam, The Netherlands.
Insights
Children experience physical and mental discomforts during clinical research. Strategies like distraction and clear information can reduce these issues, improving the research experience.
Area of Science:
- Pediatric Research
- Clinical Trials
- Patient Experience
Background:
- Limited empirical data exists on children's subjective discomforts in clinical research.
- Institutional Review Boards (IRBs) lack sufficient information to guide decisions on children's research participation.
- Understanding children's experiences is crucial for ethical research conduct.
Purpose of the Study:
- To explore children's subjective experiences of discomfort during clinical research procedures.
- To gather children's suggestions for mitigating discomforts in research settings.
- To provide empirical evidence for IRBs regarding pediatric research discomforts.
Main Methods:
- Qualitative study involving interviews with 46 children (aged 6-18) undergoing various clinical research procedures.
- Procedures included needle-related interventions, food challenges, MRI scans, pulmonary function tests, and questionnaires.
- Thematic analysis was employed to analyze interview data.
Main Results:
- Discomforts were categorized into physical (pain, breathlessness, nausea, itchiness, hunger) and mental (anxiety, boredom, tiredness, embarrassment).
- Physical discomforts were frequently linked to needle procedures, pulmonary tests, and food challenges.
- Mental discomforts stemmed from anticipation, procedural uncertainty, lengthy durations, and specific assessments like Tanner staging.
Conclusions:
- Children report diverse physical and mental discomforts during clinical research.
- Children suggested practical strategies for reducing discomfort, including distraction, age-appropriate information, and shorter procedure times.
- Further quantitative research is recommended to assess the prevalence of these discomforts.
Introduction:
There is little empirical evidence on children's subjective experiences of discomfort during clinical research procedures. Therefore, Institutional Review Boards have limited empirical information to guide their decision-making on discomforts for children in clinical research. To get more insight into what children's discomforts are during clinical research procedures, we interviewed a group of children on this topic and also asked for suggestions to reduce possible discomforts.
Materials And Methods:
Forty-six children (aged 6-18) participating in clinical research studies (including needle-related procedures, food provocation tests, MRI scans, pulmonary function tests, questionnaires) were interviewed about their experiences during the research procedures. Thematic analysis was used to analyze the interviews.
Results:
The discomforts of the interviewed children could be divided into two main groups: physical and mental discomforts. The majority experienced physical discomforts during the research procedures: pain, shortness of breath, nausea, itchiness, and feeling hungry, which were often caused by needle procedures, some pulmonary procedures, and food provocation tests. Mental discomforts included anxiousness because of anticipated pain and not knowing what to expect from a research procedure, boredom and tiredness during lengthy research procedures and waiting, and embarrassment during Tanner staging. Children's suggestions to reduce the discomforts of the research procedures were providing distraction (e.g. watching a movie or listening to music), providing age-appropriate information and shortening the duration of lengthy procedures.
Discussion:
Our study shows that children can experience various discomforts during research procedures, and it provides information about how these discomforts can be reduced according to them. Further research is needed with larger samples to study the number of children that experience these mentioned discomforts during research procedures in a quantitative way.
