Olsen 2007.
Study characteristics | ||
Methods | Randomised controlled trial | |
Participants | Setting: single‐centre study at the Sahlgrenska University Hospital, Gothenburg, Sweden during 2004 Inclusion criteria: 22 women following uncomplicated vaginal birth and painful postpartum uterine contractions requiring pain relief Exclusion criteria: women with systemic disorders; abnormal pregnancy; operative delivery and receiving analgesic treatment for other pain; Swedish as 2nd language |
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Interventions | Women were randomly allocated to 1 of 2 treatment groups:
In both groups the TENS electrodes were placed over the lower part of the abdomen bilaterally over the uterus |
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Outcomes | Adequate pain relief as reported by the woman: women were asked to estimate their pain intensity using a 100 mm VAS ranging from no pain to worst possible pain, before and after treatment
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Notes | Dates of study: women recruited in 2004 Funding sources: not stated Declarations of interest: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Women were randomised using a "computer generated random table" |
Allocation concealment (selection bias) | Low risk | Quote: "Groups coded and transferred to pre‐sealed opaque envelopes" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible to blind study personnel |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There were 13 women allocated to the HI TENS group and 8 women to the LI TENS group. The data from 1 of 13 women (8%) in 1 allocated to the HI TENS intervention group was excluded because she withdrew after experiencing discomfort |
Selective reporting (reporting bias) | Unclear risk | No published protocol or trial registration available |
Other bias | High risk | Baseline imbalance ‐ numbers in abstract differ from those given in results |