Methods | Randomised trial (methods unclear). | |
Participants | 25 women (30 women were recruited to this 5-arm trial, we have not included data for the arm where women (n = 5) were allocated to receive pethidine) Inclusion criteria: “co-operative patients” with no drug dependency. Various ages and social groups Exclusion criteria: unclear. |
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Interventions | 5 study groups: 1) TENS group - TENS to lower back (10 women). 2) 50 mg pethidine (5 women). 3) Placebo TENS (no current) (5 women). 4) “Wrong” TENS (electrodes applied to wrong positions) (5 women) 5) No analgesia or intervention (5 women). |
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Outcomes | Pain measured on a VAS over 70-minute period. Progress in labour | |
Notes | Paper in German. Translation notes used for data extraction. In the analysis in this review study groups 3 to 5 have been combined to form the control group |
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Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described - “randomly divided”. |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding (performance bias and detection bias) Participants |
Unclear risk | The study included two placebo TENS devices (TENS with no current or TENS with the electrodes in the wrong position). It is not clear if the placebo devices were convincing to women or others |
Blinding (performance bias and detection bias) Clinical staff |
Unclear risk | It is not clear if the placebo devices were convincing to women or others |
Blinding (performance bias and detection bias) Outcome assessor |
Unclear risk | It is not clear if the placebo devices were convincing to women or others |
Incomplete outcome data (attrition bias) All outcomes |
Unclear risk | One woman was lost to follow up. |
Other bias | Unclear risk | Small study and results were difficult to interpret. |