Fowler‐Kerry 1987.

Study characteristics
Methods	RCT. 5 arms.
Participants	Number of children: 80 control, 120 treatment Sex of children: 100 M, 100 F Age range of children: 4.5 ‐ 6.5 years Mean age of children: 5.5 years Needle procedure: immunization Diagnosis of child: none Inclusion criteria: 4.5 ‐ 7 years old, healthy children Exclusion criteria: none given Setting: patients attending 1 of 3 community health clinics located near a large metropolitan area in Canada
Interventions	1.Music distraction through headphones: Age‐appropriate music using headphones, played immediately prior to and during the injection. 2. Suggestion: Children were told that the experimenter was going to help them when they had their injection. They wore headphones but no music was played. 3. Music distraction and suggestion: Children were told that the experimenter was going to help them when they had their injection. They wore headphones and music was played. 4. Control condition with headphones: Children did not receive distraction or suggestion, but did wear headphones. 5. Control condition without headphones: Children did not receive distraction or suggestion, and did not wear headphones.
Outcomes	Pain measure: Child self‐report: 4‐point VAS Adverse events: none mentioned
Notes	We used a total N of 160 for this study (instead of 200), because we only included 4 of 5 interventions (Distraction versus Combined 2 Control Conditions and Suggestion versus Combined 2 Control Conditions). Study dates: study dates not reported Funding: grant from the Alberta Association of Registered Nurses Conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomized ‐ randomly assigned with the restriction that there be equal numbers of boys and girls in each group ‐ no further details. Insufficient information to permit judgment of 'low' or 'high' risk
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	Although authors report blinding of participants and personnel, the nature of psychological intervention precludes this
Blinding of outcome assessment (detection bias) All outcomes	High risk	No blinding of self‐report outcome assessment (see previous comment)
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	Unclear risk	Insufficient information to assess whether an important risk of bias exists (e.g., "failure of suggestion may be attributed to an ineffective suggestion statement" p.174 Par 2)