Mothers’ perceptions of their child’s enrollment in a randomized clinical trial: poor understanding, vulnerability and contradictory feelings
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2013
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Resumo
Background: Little is known about the views of mothers when their children are invited to participate in
randomized clinical trials (RCTs) investigating medicines and/or invasive procedures. Our goal was to understand
mothers’ perceptions of the processes of informed consent and randomization in a RCT that divided uncooperative
children into three intervention groups (physical restraint, sedation, and general anesthesia) for dental rehabilitation.
Methods: This is a qualitative study based on semi-structured interviews with mothers accompanying children
under 3 years old presenting severe early childhood caries. Their responses were analyzed using content analysis.
Results: We identified one major theme from 15 mothers’ responses – “Understanding of, attitudes toward, and
feelings about consenting to participate in a RCT involving advanced behavior guidance techniques and about
randomization” – that was derived from the following subcategories: confusion in defining techniques, questions
after signing the consent form, lack of knowledge about the techniques, acceptance or questioning of the drawing,
sharing responsibility with the child during the drawing, and feelings of faith in God, fear, powerlessness to choose,
and relief from or an increase in pressure.
Conclusions: Despite mothers’ misunderstanding, vulnerability, and contradictory feelings, they were willing to
overlook their thoughts in order to complete their children’s dental treatment.
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Dental care for children, Randomized controlled trial, Qualitative research, Bioethics
Citação
CARVALHO, Adriana Assis; COSTA, Luciane Rezende. Mothers' perceptions of their child-s enrollment in a randomized clinical trial: poor understanding, vulnerability and contradictory feelings. BMC Medical Ethics, London, v. 14, n. 52, p. 1-8, 2013.