Objective. This study evaluated a combined pharmacologic and psycholog
ic intervention (combined intervention, CI) relative to a pharmacologi
c-only (PO) intervention in reducing child distress during invasive pr
ocedures 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 w
as 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, s
taff and parent ratings, and data on medications administered, technic
al difficulty of the procedure, and needle insertions were obtained fo
r each procedure. This article reports on the final data point for the
project (>12 months). Results. Mothers and nurses reported lower leve
ls 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-secti
onal control group. Distress decreased throughout the time, and child
age was inversely related to distress (younger children had more distr
ess) regardless of group. Child distress was associated with staff per
ceptions of the technical difficulty of the procedure and with child a
ge, but not with medications administered. Conclusions. The data showe
d that pharmacologic and psychologic interventions for procedural dist
ress were effective in reducing child and parent distress and support
integration of the two approaches. Younger children experienced more d
istress and warranted additional consideration. Staff perceptions of t
he technical difficulty of procedures were complex and potentially hel
pful in designing intervention protocols.