| Methods |
Design: four group parallel trial
Purpose: study the effect of hypnosis on procedure‐related pain |
| Participants |
Patients: children (6 to 16 years) with cancer
Baseline comparability: yes |
| Interventions |
Placebo: attention control treatment ('development of rapport, nonmedical play, nonmedical verbal interaction'. Therapist was 'supportive, warm, encouraged the child to express freely their interests, and formed a close relationship with the child.'
Untreated: no hypnosis
Experimental:
‐direct hypnosis (hypnotic indiction by reference to request for numbness and imagining 'numbing medicine', etc)
‐indirect hypnosis (hypnotic induction by reference to 'the setting sun metaphor' and the 'Mexican food metaphor')
(Co‐intervention: standard medical care) |
| Outcomes |
Pain (6 point scale)
Anxiety
Observed distress |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Unclear risk |
NS |
| 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? |
Low risk |
No variance inequality (F‐test not statistically significant) and no skewness (1.64 standard deviations does not exceed the mean) |
| Trial size > 49? |
High risk |
N = 40 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
