BACKGROUND: Needle-related procedures are a common source of pain and distress for children. Several psychological (cognitive-behavioral) interventions to help manage or reduce pain and distress are available; however, a previous comprehensive systematic review of the efficacy of these interventions has not been conducted. OBJECTIVES: To assess the efficacy of cognitive-behavioral psychological interventions for needle-related procedural pain and distress in children and adolescents. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library (Issue 4, 2005), MEDLINE (1966 to 2005), PsycINFO (1887 to 2005), EMBASE (1974 to 2005), the Cumulative Index to Nursing and Allied Health Literature (1982 to 2005), Web of Science (1980 to 2005), and Dissertation-Abstracts International (1980 to 2005). We also searched citation lists and contacted researchers via various electronic list-servers and via email requests. SELECTION CRITERIA: Participants included children and adolescents aged two to 19 years undergoing needle-related procedures. Only randomized controlled trials (RCTs) with at least five participants in each study arm comparing a psychological intervention group with a control or comparison group were eligible for inclusion. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed trial quality. Included studies were coded for quality using the Oxford Quality Scale devised by Jadad and colleagues. Standardized mean differences with 95% confidence intervals were computed for all analyses using RevMan 4.0 software. MAIN RESULTS: Twenty eight trials with 1951 participants were included. Together, these studies included 1039 participants in treatment conditions and 951 in control conditions. The most commonly studied needle-procedures were immunizations and injections. The largest effect sizes for treatment improvement over control conditions exist for distraction (on self-reported pain, SMD -0.24 (95% CI -0.45 to -0.04), combined cognitive-behavioral interventions--reduced other-reported distress (SMD -0.88, 95% CI -1.65 to -0.12; and behavioral measures of distress (SMD -0.67, 95% CI -0.95 to -0.38) with hypnosis being the most promising--self-reported pain (SMD -1.47, 95% CI -2.67 to -0.27), with promising but limited evidence for the efficacy of numerous other psychological interventions, such as information/preparation, nurse coaching plus distraction, parent positioning plus distraction, and distraction plus suggestion. AUTHORS' CONCLUSIONS: Overall, there is preliminary evidence that a variety of cognitive-behavioral interventions can be used with children and adolescents to successfully manage or reduce pain and distress associated with needle-related procedures. However, many of the included studies received lower quality scores because they failed to describe the randomization procedure and participant withdrawals or drop-outs from the study. Further RCTs need to be conducted, particularly for the many interventions for which we could not locate any trials.