Tak 2006.

Study characteristics
Methods	RCT. 6 arms.
Participants	Number of children: 20 control, 20 treatment Sex of children: 25 M, 15 F Age range of children: 3 ‐ 12 years Mean age of children: 6.6 ± 2.9 years (intervention); 6.6 ± 2.7 years (control) Needle procedure: venepuncture Diagnosis: none reported Inclusion criteria: Dutch children receiving a venepuncture Exclusion criteria: children of non‐Dutch parentage Setting: outpatient centre of the St Antonius Ziekenhuis in Nieuwegein (the Netherlands)
Interventions	Definitions for the following condition components are provided below. 1. Placebo, distraction, information 2. EMLA, distraction, information 3. Placebo, information 4. EMLA, information 5. Information 6. Non‐treatment control Distraction: During the venepuncture, a funny 6‐minute fragment of a video cartoon (Walk Disney's 'Beauty and the Beast') was shown. Sound could be heard through a headphone. Procedural Information: All children except those in the control groups received information on the venepuncture by means of a photo book. The supervising research assistant asked the child to read the book with his/her parent(s) while in the waiting room. The 24 photos, each accompanied by a short and simple text, showed step‐by‐step what was to come from entrance to departure from the hospital. A boy 8 years old acted as the model. EMLA: EMLA cream was applied by the laboratory personnel on duty who did not know whether the cream was EMLA or a placebo cream. These were not necessarily the same persons as those who did the pricking. Placebo: A placebo cream was applied by the laboratory personnel on duty who did not know whether the cream was EMLA or a placebo cream. These were not necessarily the same persons as those who did the pricking. *Because EMLA requires 1 hour to produce its effect, the children in the4 ‘cream conditions’ passed that time in the waiting room in the presence of their parent(s). Non‐treatment control: no treatment provided
Outcomes	Pain measure: Child self‐report: Oucher scale (for children < 6 years) Child self‐report: VAS (for children > 6 years) Distress measure: Behavioral: Groningen Distress Scale (GDS) Adverse events: none mentioned
Notes	We used a total N of 94 for this study (instead of 136) because we only included 4 of 6 conditions (i.e. placebo, distraction, information versus placebo, information and information versus non‐treatment control). Although GDS ratings were calculated at 3 time points in this study (child entering the room, just before venepuncture, and during venepuncture), we only used the 'during venepuncture' scores in the analyses for this review. Study dates: September 1993 to February 1995 Funding: none stated Conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomized ‐ no further details. 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 and personnel were not blinded
Blinding of outcome assessment (detection bias) All outcomes	High risk	No blinding of outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No reasons for missing data provided
Selective reporting (reporting bias)	Unclear risk	Insufficient information to permit judgment of 'low' or 'high' risk
Other bias	Unclear risk	Insufficient information to assess whether an important risk of bias exists