Kuttner 1987.
Study characteristics | ||
Methods | RCT. 3 arms. | |
Participants | Number of children: 8 control, 17 treatment Sex of children: not reported Age range of children: 3 ‐ 6 years Mean age of children: not reported Needle procedure: BMA Diagnosis of child: leukemia Inclusion criteria: leukemia patients who had expressed difficulty in coping with recurrent BMAs and LPs that constituted an essential part of their treatment for cancer Exclusion criteria: none reported Setting: treatment/surgery room at children's hospital in Canada |
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Interventions | 1. Hypnosis: Hypnotic techniques included using the child’s favorite story for hypnotic suggestion and reframing of the experience. Children practised the therapist‐led technique prior to the procedure. Procedural and sensory information was interwoven into the storyline. 2. Distraction: Distracters included books, bubbles, and toys. 3. Standard care control: Standard medical practice included information, reassurance, and support. |
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Outcomes | Pain measure:
Distress measure:
Adverse events: none mentioned |
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Notes | Data necessary for the meta‐analysis pooling (i.e. means and SDs) was reported for the PBRS‐R only. Also, because there were 2 treatment sessions, data were reported for 3 time points (i.e. baseline, 1st intervention, 2nd intervention). For the analyses in this review, we used data for the 1st intervention only. Study dates: study dates not reported Funding: BC Health Care Research Foundation Grant #54‐82‐2. 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 ‐ 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 and personnel were not blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding of outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient reporting of exclusions to permit judgment of 'low' or 'high' risk. One or more outcomes of interest are reported incompletely. |
Selective reporting (reporting bias) | High risk | One or more outcomes of interest are reported incompletely. |
Other bias | High risk | Multiple potential sources of bias related to study design (e.g. small sample size) |