Liossi 2003.
Study characteristics | ||
Methods | RCT. 4 arms. | |
Participants | Number of children: 20 control, 40 treatment Sex of children: Not reported Age range of children: 6 ‐ 16 years Mean age of children: 8.73 ± 2.86 years Needle procedure: LP Diagnosis of child: leukemia or non‐Hodgkin’s lymphoma Inclusion criteria: 6 ‐ 16 years old, with leukemia or non‐Hodgkin’s lymphoma, undergoing regular LPs over a 4‐year period Exclusion criteria: previous hypnosis treatment, concurrent treatment during the project with analgesic or psychotropic medication, major affective disorder or other psychiatric diagnosis Setting: Hematology/Oncology Department of the Children’s Hospital Aglaia Kyriakou, Athens, Greece |
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Interventions | 1. Hypnosis (direct): Prior to the procedure, children practised analgesic hypnotic suggestions (request for numbness, topical/local/glove anesthesia, and switchbox). This was repeated during the procedure with the help of the therapist. 2. Hypnosis (indirect): Prior to the procedure, children practised hypnotic suggestion to experience immediate relaxation and adaptation to discomfort. This was repeated during the procedure with the help of the therapist. 3. Standard care with attention control: Included elements such as development of rapport, non‐medical play, and non‐medical verbal interactions (e.g. discussing school, activities, sports, etc). New coping skills were not introduced. 4. Standard care control: Children received no therapist contact or treatment intervention, but, like all patients, received standard interventions provided by the hospital staff for pain control during LPs (i.e. medical and nursing staff offered information, support, and reassurance). |
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Outcomes | Pain measure:
Distress measure:
Adverse events: none mentioned |
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Notes | We used a total N of 60 for this study (instead of 80) because we only included 3 of 4 conditions (Direct + indirect hypnosis versus attentional control with standard medical treatment). Outcomes were assessed at various time points; however, for this review we only used the 'intervention' time point. Study dates: over a 4‐year period (study years not reported) Funding: none stated 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 | Low risk | No missing data |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgment of 'low' or 'high' risk |
Other bias | Low risk | Appears to be free of other bias that would affect outcomes |