Liossi 2009.
Study characteristics | ||
Methods | RCT. 3 arms. | |
Participants | Number of children: 15 control, 15 treatment Sex of children: 14 M, 16 F Age range of children: 6 ‐ 16 years Mean age of children: 8.5 ± 2.21 years Needle procedure: venepuncture Diagnosis: pediatric outpatients Inclusion criteria: 7 ‐ 16 years old, Greek‐speaking patients with cancer, off active treatment and undergoing regular venepuncture as part of disease status monitoring, had 1 parent in attendance Exclusion criteria: major affective psychiatric disorders within last 5 years, concurrent treatment during project with analgesic or psychotropic medication, no clearly visible veins as judged by nurse performing procedure, diagnosis of anxiety or mood disorder or other psychiatric diagnosis in past 5 years Setting: Hematology/Oncology Department, Athens, Greece |
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Interventions | 1. Hypnosis (and EMLA):Prior to the procedure, hypnosis was practised 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). Children were then taught self‐hypnosis following an abbreviated version of Gardner’s model. EMLA was applied 60 minutes prior to the procedure and children were cued by their parent 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: Treated only with EMLA cream applied to the intact skin for approximately 60 minutes before the procedure. The other 2 groups also received the same EMLA application. |
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Outcomes | Pain measure:
Distress measure:
Adverse events: none mentioned |
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Notes | The study involved 3 time points (Time 1, Time 2, and Time 3) but we only included Time 1 which occurred during the venepuncture and closest to the intervention. Times 2 and 3 were 3 and 6 months after the initial session and did not involve therapist‐led intervention; therefore, we did not include them in this review. Also, 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). 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 using computer‐generated random positive integers (p. 256 Par 4) |
Allocation concealment (selection bias) | High risk | Used an open random allocation schedule (p. 256 par 11) |
Blinding of participants and personnel (performance bias) All outcomes | High risk | 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 |