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. 2018 Oct 4;2018(10):CD005179. doi: 10.1002/14651858.CD005179.pub4

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
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).
Outcomes Pain measure:
  • Child self‐report: Wong Baker FACES Scale


Distress measure:
  • Child self‐report: Wong Baker FACES Scale

  • Behavioral: Procedure Behavior Checklist (PBCL)


Adverse events: none mentioned
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
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