Study protocol for a randomized controlled trial of a child and parent mindfulness intervention for pediatric venipuncture

Abstract

Children commonly undergo painful needle procedures. Unmanaged procedural pain can have short- and long-term consequences, including longer procedure times, greater distress at future procedures, and vaccine hesitancy. While parent behaviors are one of the strongest predictors of children's response to acute pain, pediatric procedural pain management interventions focus almost exclusively on the child. Further, existing parent-involved pediatric pain management interventions typically fail to improve child self-reported pain during painful procedures. The current protocol offers the first randomized controlled trial involving a mindfulness intervention for pediatric acute pain that includes children and their parents. This study aims to conduct a single-site, two-arm, parallel-group RCT to examine the effects of a mindfulness intervention for parents and children before child venipuncture compared to a control group on primary (child self-report of pain and fear), secondary (parent self-report and child report of parent distress), and tertiary outcomes (parent report of child pain and fear). Parent-child dyads (n = 150) will be recruited from the McMaster Children's Hospital outpatient blood laboratory. Dyads will be randomly assigned to either a mindfulness group guided through a mindfulness intervention or control group guided through an unfocused attention task. Parents will accompany their child for their venipuncture. Postvenipuncture measures will be collected (eg, child pain-related outcomes as reported by parents and children). The first enrollment occurred in October 2019. We offer a novel intervention that aims to facilitate both parent and child coping during child venipuncture.

Keywords: RCT; mindfulness; needle; pediatric pain.

Figure 1

*Variables captured in Study 2 (see Appendix S1). Italicized text indicates variables not captured in the study. This is an adapted image of study variables mapped onto the Social Communication Model of Pain. In considering the Social Communication Model, the proposed randomized controlled trial aims to target the intrapersonal processes of both the child and parent in addition to indirectly seeking to address the interpersonal process. Specifically, child intrapersonal factors targeted in the intervention include the sensory, emotional, and cognitive aspects of the pain experience. Parent intrapersonal factors targeted in the intervention include parent decoding of the child's pain experience. Thus, we hypothesize that the dyadic mindfulness intervention will improve child pain and related outcomes and parent experience of child pain. We aim to reduce parent distress by changing their decoding of child pain expression to be reflective instead of reflexive. This may improve parent ability to support child coping via reduced parent distress. Study 2 will investigate parent and child trait levels of catastrophizing, experiential avoidance, and mindfulness to assess whether these intrapersonal variables impact responding to condition (see Appendix S1)