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

Windich‐Biermeier 2007.

Study characteristics
Methods RCT. 2 arms.
Participants Number of children: 28 control, 22 treatment
Sex of children: 27 M, 23 F
Age range of children: 5 ‐ 18 years
Mean age of children: 10.5 ± 3.8 years
Needle procedure: venous port access or venepuncture
Diagnosis: cancer
Inclusion criteria: 5 ‐ 18 years old, able to understand and speak English, able to hear and see, had a diagnosis of leukemia, lymphoma, a solid tumor, histiocytosis, were receiving chemotherapy, had a physician order for a port access/venepuncture, had a least 1 previous access/venepuncture
Exclusion criteria: septic, dehydrated, vomiting, sedated, medically unstable, diagnosed with mental illness, or scheduled for another procedure following port access/venepuncture
Setting: hospital pediatric medical centre in the southwestern United States
Interventions 1. Parent coaching and child distraction: In addition to standard care, children chose 1 distracter (book, bubbles, music, Gameboy, or virtual reality glasses). Parents were instructed to actively coach the child throughout the procedure to use the distracter.
2. Standard care control: Included an explanation of the procedure, use of topical anesthetic, and parental presence during the procedure.
Outcomes Pain measure:
  • Child self‐report: CAS


Distress measures:
  • Child self‐report: GFS

  • Parent report: GFS

  • Nurse report: GFS

  • Behavioral: OSBD


Adverse events: none mentioned
Notes Data for parent‐reported fear, nurse‐reported fear, and OBSD broken down by group (intervention versus control) were not reported, and therefore could not be included in the analyses for this review. Also, although the authors label the intervention as "distraction", they describe it as involving distraction with parent coaching. We therefore classified it in the 'Parent Coaching + Child Distraction' intervention category for this review. Lastly, the intervention and control groups differed in terms of various variables (e.g. type of topical analgesic used, parental presence, number of cannulation attempts); however, there were no statistically significant differences between the groups on any of these variables.
Study dates: study dates not reported
Funding: American Holistic Nurses’ Association, Children’s Medical Center Dallas Foundation, and Children’s Medical Center Dallas Woman’s Auxiliary
Conflicts of interest: none declared.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "randomly assigned using an SPSS pseudo‐random number generator" (p. 9)
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 self‐report outcome assessment
Incomplete outcome data (attrition bias)
All outcomes Low risk No missing data
Selective reporting (reporting bias) High risk One or more outcomes of interest are reported incompletely
Other bias Unclear risk Insufficient information to assess whether an important risk of bias exists