Bastani 2006.
| Methods | Randomised trial | |
| Participants | Iran 110 primigravida women with high levels of anxiety (initial state/trait anxiety scores over 30) recruited from 3 prenatal clinics in Iran Inclusion criteria: primigravida women with a wanted pregnancy, aged 18 to 30, between 14 and 28 weeks' gestation, high levels of anxiety, uncomplicated singleton pregnancies and no identified medical or obstetrical risk factors Exclusion criteria: any medical or obstetric complication during the 7 weeks of intervention and elective caesarean section |
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| Interventions | Nurse‐led 7‐week applied relaxation training in groups Control: routine hospital‐based prenatal care | |
| Outcomes | Non‐vaginal deliveries (surgical or caesarean section and instrumental deliveries including forceps and vacuum extraction), preterm birth, low birth weight | |
| Notes | Baseline (control group) CS rate: 40% Date of study: October 2002 to February 2003 Funding: Not reported Conflicts of interest: Not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Randomly assigned to 2 groups, using a block randomisation method". Unclear on the size of the blocks |
| Allocation concealment (selection bias) | Unclear risk | "Randomly assigned to 2 groups, using a block randomisation method". Unclear on the size of the blocks |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information provided in the report |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Main outcomes (modes of delivery) objective |
| Baseline characteristics similar? | Low risk | "No differences in the demographic variables...or the dependent variables" |
| Baseline outcome measurements similar? | Low risk | "No significant differences in state/anxiety...and perceived stress between the groups before intervention" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data |
| Selective reporting (reporting bias) | Low risk | Prespecified outcomes reported |
| Protected against contamination? | Unclear risk | Insufficient information available to assess likelihood of contamination |
| Other bias | Low risk | No evidence of other bias |