Goodenough 1997.
Study characteristics | ||
Methods | RCT. 3 arms. | |
Participants | Number of children: 117 (39 in each group) Sex of children: 73 M, 44 F Age range of children: 3.5 ‐ 17.7 years Mean age range of children: not reported Needle procedure: venipuncture Diagnosis of child: none given (19.7% receiving investigation for chronic illness, 30.8% receiving routine investigation prior to hospital admission, 9.4% undergoing assessment of blood medication levels, 40% being treated for a variety of complaints) Inclusion criteria: 3 ‐ 17 years, consecutively scheduled to undergo venipuncture Exclusion: a major mental handicap Setting: Sydney Children’s Hospital, Australia |
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Interventions | 1. Placebo cream plus suggestion: Children were given a placebo cream from a brightly‐wrapped container as the nurse said: “We are trying out a new special cream. I am going to put some cream on your arm that might make the needle hurt less.” 2. Placebo cream alone: Children were given a placebo cream from a plain white wrapped container as the nurse said: “I am going to put some cream on your arm.” 3. No cream control: No cream was applied and the nurse did not say anything beyond standard procedural instruction |
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Outcomes | Pain measures:
Distress measures:
Adverse events: none mentioned |
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Notes | We used a total N of 78 for this study (instead of 117) because we only included 2 of 3 interventions (placebo cream + Suggestion versus placebo cream alone). Study dates: study dates not reported Funding: Big Brother Movement, Brambles, Boots Co. (Australia), and private donations. Placebo cream was kindly supplied by the Pharmacy Department, Prince of Wales Hospital, Australia Conflicts of interest: none declared |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomized ‐ stratified by age ‐ 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 | Unclear risk | Insufficient information to permit judgment of 'low' or 'high' risk |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information to permit judgment of 'low' or 'high' risk |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Reasons for missing data unlikely to be related to true outcome |
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 |