Katz 1987.
Study characteristics | ||
Methods | RCT. 2 arms | |
Participants | Number of children: 18 control, 18 treatment Sex of children: 24 M, 12 F Age range of children: 6 ‐ 11 years Mean age of children: 8.3 ± 1.68 years Needle procedure: BMA Diagnosis of child: acute lymphoblastic leukemia (ALL) Inclusion criteria: baseline self‐reported pain score > 50 (0 ‐ 100), baseline self‐reported fear score > 4 (1 ‐ 7), PBRS‐R > 4 (0 ‐ 33), nurse rating of child anxiety > 3 (1 ‐ 5) Exclusion criteria: none reported. Setting: Hematology‐Oncology clinic at Children’s Hospital of Los Angeles, USA |
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Interventions | 1.Hypnosis: Children received training in hypnosis and self‐hypnosis from trained psychologist prior to needle procedure. Hypnotic induction used eye fixation with or without eye closure, active imagery tailored to child’s interests, deep muscle relaxation, and suggestions. Children were cued to use hypnosis during actual procedure. 2. Non‐directed play control: Children engaged in play sessions designed to match the amount of time and attention from a psychologist prior to the needle procedure. No discussions about the child’s illness or treatment were initiated. |
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Outcomes | Pain measure:
Distress measure:
Adverse events: none mentioned |
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Notes | We only used data from the first BMA procedure (i.e. post‐treatment 1) Study dates: September 1979 to July 1982 Funding: grant #R01‐6292 from the National Cancer Institute Conflicts of interest: none declared |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomized ‐ stratified by sex ‐ no further details. Insufficient information to permit judgment of 'low' or 'high' risk |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgment of 'low' or 'high' risk |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Study participants were not blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding of self‐reported outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgment of 'low' or 'high' risk |
Other bias | High risk | Potential source of bias related to timing of outcome measurement (e.g. sometimes after multiple procedures) |