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.

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

“…The data for this study were collected as part of a larger single‐site, two‐arm, parallel‐group randomized control trial (RCT, registration number NCT03941717; for details on methodology, see Moline et al., 2021). Approval for the current study was obtained from the Hamilton Integrated Research Ethics Board and from the Research Ethics Board at the University of Guelph.…”

“…Parents completed the Pain Catastrophizing Scale for Parents‐State (PCS‐P‐State) and the Short Form of the State–Trait Anxiety Inventory‐State (SF‐STAI‐State) on a tablet. Dyads were then randomly assigned to either a mindfulness group (i.e., brief mindfulness intervention) or control group (i.e., unfocused attention exercise), which involved listening to a 5‐min audio recording (see Moline et al., 2021 for the intervention and control audio scripts). Next, each parent accompanied their child for the venipuncture, which was provided as usual, except the dyad wore ECG equipment.…”

“…However, the effects of mindfulness on both parent and child emotion regulation in the context of acute pediatric pain remain to be examined. By targeting cognitive and affective reactions, mindfulness practice may help shift automatic self‐oriented distress responses that some parents experience, to promote other‐oriented responses that are in greater congruence with their child's needs (Moline et al., 2021). Similarly, children's emotion regulation may be enhanced through mindfulness practice by altering the child's way of relating to the nociceptive stimulus, to attenuate the impact of distressing thoughts and emotions thereby improving the subjective pain experience (Petter et al., 2013).…”

Biopsychosocial Contributors to Parent Behaviors during Child Venipuncture

“…Parents self-reported on state pain catastrophizing and anxiety through online survey software on a tablet. Parents and their child were randomly assigned to either a mindfulness group (i.e., brief mindfulness intervention; n = 31) or control group (i.e., unfocused attention task; n = 30), in which dyads listened to a 5-min audio recording (see [ 24 ] for protocol). Baseline HRV was acquired during the first 30 s of the audio.…”

“…The following supporting information can be downloaded at: https: //www.mdpi.com/article/10.3390/children9071000/s1, Figure S1: Visual depiction of objective 1, examining whether emotion regulation capacity (via baseline HRV) moderates the association between parents' cognitive-affective states (measured before the procedure) and their behaviors (during the entire procedure); Figure S2: Visual depiction of objective 2, examining whether parent emotion regulation capacity (via baseline HRV) moderates the association between child displays of distress and parent behaviors; Table S1: Reasons for cardiac and observational data not being usable from a sample of 61 parents; Table S2: Excerpts from scripts for audio recording during baseline HRV based on participant and RCT group. For full scripts see Moline et al [24]; Table S3: Demographic characteristics of the sample (n = 61).…”