Crevatin 2016.
Study characteristics | ||
Methods | RCT. 2 arms. | |
Participants | Number of children: 100 control, 100 treatment Sex of children: 98 M, 102 F Age range of children: 4 ‐ 13 years Mean age range of children: 8.6 years (treatment); 8.9 years (control) Needle procedure: venipuncture Diagnosis of child: 12% (treatment) and 19% (control) with mixed chronic disease Inclusion criteria: 4 ‐ 13 years, at blood drawing center to have blood sample collected by venipuncture Exclusion criteria: patient history of epilepsy, use of topical, enteral or parenteral analgesics up to 8 hours before blood drawing, inability to have venipuncture performed on their hand or arm, presence of cognitive impairment or inability to report pain verbally Setting: blood‐drawing center of tertiary‐level children’s hospital in Italy |
|
Interventions | 1. Hand‐held computer distraction: Children played Angry Birds, a game in which they had to shoot birds into the pig’s fortresses, on a hand‐held computer. Children started to play the game 3 minutes before the procedure and then continued for a maximum of 3 minutes after the procedure. 2. Nurse‐led low‐tech distraction (‘Standard care’): Children received various kinds of conventional distractions from a nurse (nurse singing a song, reading a book, blowing bubbles, performing a puppet show) starting 3 minutes before the procedure. The technique that most engaged the child was continued during the procedure. |
|
Outcomes | Pain measures:
Adverse events: none mentioned |
|
Notes | Study dates: March to June 2013 Funding: none stated Conflicts of interest: none declared |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "generated using a computer‐based method" p.931 |
Allocation concealment (selection bias) | Low risk | Quote: "guaranteed using sealed consecutively numbered opaque envelopes" p.931 |
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) | Low risk | Primary and secondary outcomes clearly stated and reported |
Other bias | Low risk | Appears to be free of other bias that would affect outcomes |