A randomized controlled prospective outcome study of a psychological and pharmacological intervention protocol for procedural distress in pediatric leukemia.

Evaluated distress during invasive procedures in childhood leukemia. Child and parent distress, assessed by questionnaires and ratings, were compared in two arms of a randomized, controlled prospective study, one a pharmacologic only (PO) (n = 45) and the other a combined pharmacologic and psychological intervention (Cl) (n = 47), at 1, 2, and 6 months after diagnosis. The cross-sectional control group (CC) consisted of parents of 70 patients in first remission prior to the prospective study. Mothers' and nurses' ratings of child distress indicated less child distress in the Cl group than the PO. When contrasted with the CC group, the Cl group showed lower levels of child distress. Data showed decreases over time in distress and concurrent improvements in quality of life and parenting stress and supported an inverse association between distress and child age.

RCT Entities:   Population Interventions Outcomes