Pourmovahed 2013.
| Study characteristics | ||
| Methods | RCT. 2 arms. | |
| Participants | Number of children: 50 control, 50 treatment Sex of children: 58 M, 42 F Age range of children: 6 ‐ 15 years Mean age range of children: 9.45 ± 2.80 years Needle procedure: LP Diagnosis of child: leukemia Inclusion criteria: 6 ‐ 15 years, coming to oncology ward suffering from leukemia and hospitalized in the pediatric ward, alertness, verbal, subjective, visual and hearing ability, absence of pain and physiological needs (thirst, need for excretion) before injection Exclusion criteria: patients who received a second injection, had respiratory difficulties Setting: pediatric ward at Shahid Sadoughi University of Medical Sciences, Yazd, Iran |
|
| Interventions | 1. Hey‐Hu regular breathing: The Hey‐Hu technique was demonstrated to the children before injection. In this method, the child takes a deep breath, exhales while whispering hey, then inhales deeply again and exhales whispering hu. This was practiced with the child before the procedure and was then performed 1 minute before until the end of the procedure. 2. Control: No specific description was mentioned in the study. |
|
| Outcomes | Pain measure:
Adverse events: 3 children discontinued intervention due to respiratory difficulties. |
|
| Notes | Registered in Iranian Registry of Clinical Trials (Code IRCT2012102311230N1 Study dates: 2011 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: "sampling method was random (using random allocation software)" (p. 565) |
| 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 outcome assessment |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing data balanced across groups and 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 |