Methods |
Design: three group parallel trial
Purpose: examine the effect of hypnosis and placebo on nausea and vomiting in children receiving chemotherapy |
Participants |
Patients: in‐patients with cancer in need of nausea‐inducing chemotherapy
Baseline comparability: chemotherapy type and dose NS |
Interventions |
Placebo: sessions with psychologists who talked with the children about what they liked
Untreated: no sessions
Experimental: sessions with hypnosis
(Co‐intervention: NS) |
Outcomes |
Nausea (VAS)
Vomiting |
Notes |
The number of patients in each group was not reported. The number was estimated to n = 10 (total patient number 30 divided by 3 groups) |
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/hypnosis) |
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? |
High risk |
No protocol available. The number of patients in each group was not reported. The number was estimated to n=10 (total patient number 30 divided by 3 groups) |
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 = 20 |
Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |