Clinical Research Directory

Applying a Small Procedure Prior to Injection/Vaccination Reduces Pain in Children

In this proposed study, the investigators aim to apply a minor procedure prior to a treatment that induces pain (e.g., injection/vaccination) to help manage pediatric pain. The proposed study builds on the well-known placebo effect, which occurs when individuals experience improvements in condition (e.g., pain relief) after using an inert substance (e.g., a placebo analgesic). This effect is primarily attributed to expectations about the placebo's effectiveness. The investigators extend this line of research by demonstrating that, under certain circumstances, merely possessing a placebo can also lead to pain relief. This possession-based placebo analgesic effect arises from a sense of ownership, which enhances the expectation that the owned placebo can provide benefits to the self. This study expands the scope of the possession-based placebo effect by examining its applicability in a real-life situation - the investigators expect that providing children with ownership of a first-aid bandage before vaccination will improve the overall pain experience. Focusing on children's pain is critical for several reasons. First, pain is a common experience for children, who are often less mature and independent than adults in assessing and managing it. This renders children a vulnerable population requiring improved pain management interventions. Unfortunately, pediatric pain recognition and treatment are still inadequate. Second, most past placebo analgesic studies have focused on adults, leading to significant knowledge gaps regarding implications for pediatric care. This knowledge gap is attributed to historical ethical and legal ambiguities that hindered randomized controlled trials involving children, resulting in exclusion from research. Third, research targeting children is essential to understand these unique circumstances and deliver appropriate benefits. The U.S. Department of Health and Human Services and the Food and Drug Administration have emphasized the need to broaden pediatric research participation. A recent motion by the Hong Kong Legislative Council on "Promoting the Development of Children's Healthcare Services" further highlights this commitment. Finally, age-related factors may influence individuals' pain outcomes or responses. Children are more susceptible to the placebo effect than adults; this may be due to the stronger influence of parental (compared to professional) expectations on pediatric pain perceptions. Thus, caution is needed when generalizing adult findings to children. Investigating pain in children is crucial for developing tailored interventions for the pediatric population. This project will allow healthcare practitioners and physicians to learn about the possibility of tailoring, forming, or optimizing medical intervention strategies to enhance positive pain outcomes and novel pain management. For instance, practitioners, clinicians, and dentists could consider tailoring therapeutic interactions and treatments by incorporating appropriate procedures to reduce undesired negative pain outcomes.