Bussone 1998.
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed at pretreatment, post‐treatment, 6 months, 12 months | |
| Participants | End of treatment: n = 35 Start of treatment: n = 35 Sex: 17 F, 18 M Mean age = 11.4 years (range 11 to 15) Source = specialised headache clinic Diagnosis = headache Mean years of pain (mean) = 2.6 |
|
| Interventions | "Biofeedback (assisted relaxation)" "Relaxation" |
|
| Outcomes | Primary pain outcome: Pain Index Primary disability outcome: none Primary depression outcome: none Primary anxiety outcome: State Trait Anxiety Index
|
|
| Notes | COI: not reported Funding: "Preparation of this research was supported in part by a research grant from the National Institute of Nuerological Disorders and Stroke, NS‐29855." |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Patients were randomly assigned to one of two experimental conditions" Comment: probably done, method not described |
| Allocation concealment (selection bias) | High risk | "... with the constraint that subjects be over‐sampled in BFB‐REL treatment (2:1 ratio) in order to make actual treatment available to as many children as possible." |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No description found in text Comment: probably not done |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts reported in study |
| Selective reporting (reporting bias) | High risk | Data incompletely reported |