| Methods |
Design: three group parallel trial
Purpose: examine the effect of cognitive‐behavior modification on coping with dental procedure stress |
| Participants |
Patients: children attending a dental clinic for a painful procedure
Baseline comparability: yes (sex, procedure) |
| Interventions |
Placebo: one session where a child received the full attention of the experimenter without implementing strategies for stress coping
Untreated: no session
Experimental: one session where stress coping strategies of a cognitive‐behavioral nature were given
(co‐intervention: NS) |
| Outcomes |
Frequency (per min) of behaviour expressing stress (facial grimaces, restlessness, moving legs and arms, sitting up, gripping chair and verbalizations) |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/cognitive‐behavior intervention) |
| Blinding?
Outcome assessor |
Low risk |
'... each child's behavior was categorized by a judge who was blind to treatment conditions' |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
| 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? |
High risk |
N = 20 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
