| Methods |
Design: three group parallel trial
Purpose: examine the effect of transcutaneous electrical nerve stimulation (TENS) for children's pain on blood sampling |
| Participants |
Patients: children attending out‐patient clinics undergoing venepuncture
Baseline comparability: yes (age, sex, expected pain, anxiety) |
| Interventions |
Placebo: TENS with machine off
Untreated: no TENS
Experimental: TENS with machine on
(Co‐intervention: NS) |
| Outcomes |
Pain (VAS, Faces Affective Pain Scale) |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Low risk |
'sealed envelopes' |
| Blinding?
Treatment provider |
High risk |
Not |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
High risk |
Either variance inequality (F‐test statistically significant) or skewness (1.64 standard deviations exceeds the mean) |
| Trial size > 49? |
Low risk |
N = 340 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
Low risk |
All three categories fulfilled |
