Liossi 2006.
Study characteristics | ||
Methods | RCT. 3 arms. | |
Participants | Number of children: 30 control (15 = with attention), 15 treatment Sex of children: 23 M, 22 F Age range of children: 6‐16 years Mean age of children: 8.84 ± 2.86 years Needle procedure: LP Diagnosis of child: leukemia or non‐Hodgkin’s lymphoma Inclusion criteria: 6 ‐ 16 years old, Greek‐speaking patients with leukemia or non‐Hodgkin’s lymphoma Exclusion criteria: Previous therapy with hypnosis, concurrent treatment during the project with analgesia or psychotropic medication, major affective disorder or other psychiatric diagnosis Setting: Hematology/Oncology Department of the Children’s Hospital Algaia Kriakou, Athens, Greece |
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Interventions | 1. Hypnosis (and EMLA):Prior to the procedure, hypnosis was practiced and involved visual imagery (favorite place, activity, or television program) and analgesic suggestion was given after several minutes (numbness, topical/local/glove anesthesia, and switchbox). EMLA was applied 60 minutes prior to the procedure and children were cued by a therapist to use the hypnosis during the procedure. 2. Attention control (and EMLA): Prior to the procedure, children met with a therapist and engaged in non‐medical play and non‐medical verbal interactions. Children also had EMLA applied 60 minutes prior to the procedure. 3. EMLA only: : 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, and EMLA cream was applied approximately 60 min before the procedure). |
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Outcomes | Pain measure:
Distress measure:
Adverse events: none mentioned |
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Notes | We used a total N of 30 for this study (instead of 45) because we only included 2 of 3 conditions (EMLA + Hypnosis versus EMLA + Attention). Outcomes were assessed at various time points; however, for this review we only used the outcomes assessed closest to the procedure (i.e., during the procedure or after the procedure if a during procedure outcome was not available). Study dates: study dates 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) | Low risk | "randomly allocated…with the use of a table of random numbers" p.308 Par 9 |
Allocation concealment (selection bias) | High risk | Use of an open random allocation schedule (e.g., random number table) |
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‐report 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 |