Mothers’ perceptions of their child’s enrollment in a randomized clinical trial: poor understanding, vulnerability and contradictory feelings

Abstract

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.