Objective: This study evaluated a combined pharmacologic and psychologic intervention (combined intervention, CI) relative to a pharmacologic-only (PO) intervention in reducing child distress during invasive procedures in childhood leukemia. Predictors of child distress included age, group (CI, PO), and procedural variables (medications and doses, technical difficulty, number of needles required).
Methodology: This was a randomized, controlled prospective study that compared the PO (n = 45) and CI arms (n = 47), at 1, 6, and >12 months after diagnosis. A cross-sectional control group consisted of parents of 70 patients in first remission before the prospective study. Parent questionnaires, staff and parent ratings, and data on medications administered, technical difficulty of the procedure, and needle insertions were obtained for each procedure. This article reports on the final data point for the project (>12 months).
Results: Mothers and nurses reported lower levels of child distress in the CI than the PO group. The CI and PO groups showed lower levels of child and parent distress than the cross-sectional control group. Distress decreased throughout the time, and child age was inversely related to distress (younger children had more distress) regardless of group. Child distress was associated with staff perceptions of the technical difficulty of the procedure and with child age, but not with medications administered.
Conclusions: The data showed that pharmacologic and psychologic interventions for procedural distress were effective in reducing child and parent distress and support integration of the two approaches. Younger children experienced more distress and warranted additional consideration. Staff perceptions of the technical difficulty of procedures were complex and potentially helpful in designing intervention protocols.