A Brief Mindfulness Intervention for Parents and Children before Pediatric Venipuncture: A Randomized Controlled Trial.

BACKGROUND: Routine needle procedures can be distressing for parents and children. Mindfulness interventions may be helpful for parents and children but have not been examined for pediatric needle procedures despite showing benefits in the context of pediatric chronic pain and in lab-based pain tasks. METHODS: This preregistered (NCT03941717) two-arm, parallel-group randomized controlled trial examined the effects of a 5 min mindfulness intervention before pediatric venipuncture for parents and children (aged 7-12) compared to a control group on primary outcomes of child pain and fear, secondary outcomes of parent distress, and tertiary outcomes of parent ratings of child pain and fear. Moderators of parent and children's responses to the intervention were examined: state catastrophizing, trait mindfulness, and experiential avoidance. RESULTS: Sixty-one parent-child dyads were randomized (31 mindfulness; 30 control). Parents and children completed measures, listened to a 5 min audio recording (mindfulness or control), and parents accompanied their child during routine venipuncture. The mindfulness intervention involved breathing and encouraging nonjudgmental attention to one's experiences, while the control condition involved an unfocused attention task. Three between-subject MANCOVAs assessed for group differences. Child pain and fear rated by children and their parents did not differ between groups. Parents in the mindfulness group were less distressed during the venipuncture than the controls. Parent state catastrophizing may have moderated the intervention effects, such that parents with moderate and high catastrophizing levels had lower distress following the mindfulness intervention versus control. CONCLUSIONS: The intervention did not reduce child pain or fear but reduced parent distress. It appeared most helpful for parents catastrophizing about their child's pain, which is noteworthy as these children are prone to worse outcomes.

Parent and child self- and co-regulation during pediatric venipuncture: Exploring heart rate variability and the effects of a mindfulness intervention.

Needle procedures are common throughout childhood and often elicit distress in children and parents. Heart rate variability (HRV), as an index of emotion regulation, can inform both self-regulatory and co-regulatory processes. Mindfulness may serve to regulate distress; however, no research has studied mindfulness or parent and child regulatory responding concurrently during venipuncture. Stemming from a randomized controlled trial investigating a mindfulness intervention, this study sought to describe regulatory responding (via HRV) throughout pediatric venipuncture and the role of cognitive-affective factors (mindfulness, parent anxiety, catastrophizing) in 61 parent-child dyads (7-12 years). We examined (1) patterns of parent and child HRV throughout venipuncture and whether a brief, randomly assigned audio-guided mindfulness versus control exercise affected this pattern and (2) the extent to which changes in parent and child HRV were synchronized throughout venipuncture, and whether parent catastrophizing and anxiety moderated this association. HRV differed as a function of procedural phase. Practicing the mindfulness versus control exercise did not consistently affect HRV in dyads. Positive synchrony was observed during the end of the intervention in dyads with high parental catastrophizing. Otherwise, a pattern of nonsynchrony emerged. Results provide foundational knowledge regarding children's internal (self) and external (parent) regulation mechanisms. RCT registration: NCT03941717.

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

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.