Bisignano 2006.

Study characteristics
Methods	RCT. 2 arms.
Participants	Number of children: 16 control, 14 treatment Sex of children: 15 M, 15 F Age range of children: 6 ‐ 18 years Mean age range of children: 11.4 years Needle procedure: IV procedures Diagnosis of child: cancer (acute lymphoblastic leukemia, sickle cell anemia, lymphoma, acute myeloid leukemia, osteosarcoma, Hodgkin’s disease, Glanzmann’s thrombasthemia, aplastic anemia, chronic myelomonocystic leukemia) Inclusion criteria: English‐speaking, 7 ‐ 18 years, scheduled for IV procedures, history of at least 2 previous IVs Exclusion: none given Setting: Hematology/Oncology clinic at large urban medical center (Harbor–University of California Los Angeles Medical Center) in the United States
Interventions	1. CD‐ROM: Children had approximately 20 minutes to interact with 2 CD‐ROMs 1 to 2 hours prior to the procedure. The first CD helped children learn about the procedure using education/information, pre‐procedural preparation (video modeling), breathing exercises, and distracting imagery. The CD allowed children to ask questions (e.g. what is an IV?), educated children on IV procedural terms, and taught children simple breathing exercises and an imagery technique. Children were also given a choice of viewing 2 videos on the IV procedure. The second CD focused on particular IV procedures used with some of the children (i.e. Hickman, Broviac, Port‐a‐cath). 2. Standard medical care: Children received the routine hospital preparation for the procedure. This preparation included an explanation of the IV procedure and application of a topical anesthetic cream approximately 1 hour prior to the procedure. Children in both groups received this preparation.
Outcomes	Pain measures: Child self‐report: Children’s Pain Self‐Report (Pain‐SR) Distress measures: Child self‐report of fear: Children’s Fear Self‐Report (Fear‐SR) post‐procedure Experimenter report of anxiety: VAS (1 ‐ 5) Procedural Behavioral Rating Scale (PBRS) during procedure Adverse events: none mentioned
Notes	Study dates: study dates not reported Funding: none stated Conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Stratified randomization process was used. Insufficient information to permit judgment of 'low' or 'high' risk
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgment of 'low' or 'high' risk
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants were not blinded
Blinding of outcome assessment (detection bias) All outcomes	High risk	No blinding of self‐report outcome assessment
Incomplete outcome data (attrition bias) All outcomes	High risk	No reason provided for missing data and imbalance in missing data across groups
Selective reporting (reporting bias)	Unclear risk	Insufficient information to permit judgment of 'low' or 'high' risk
Other bias	High risk	Multiple potential sources of bias related to study design and other problems