Study protocol for a randomized controlled trial of a child and parent mindfulness intervention for pediatric venipuncture
Bibliographic record
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.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".