Lima 2014.
Study characteristics | ||
Methods | Randomised controlled single‐blind study, Brazil. | |
Participants | 34 women undergoing caesarean delivery (primiparous or multiparous), aged more than 18 years (18 to 42 years), with pain greater than 3, undergoing spinal anaesthesia and incision P‐fannestiel, literate, oriented and absence of pathology genitourinary. There were three treatment groups: TENS High frequency (n: 13), TENS low frequency (n: 12), and one placebo group (n: 9). | |
Interventions | 13 women received TENS high frequency 100 Hz (G100), 12 women in the TENS low frequency 4 Hz (G4) and 9 women in the placebo group (GP) (appliance off), the pulse duration of 100 μs with a current intensity of according to the threshold of each participant. The TENS device was continuously used for 30 minutes in each participant, only 1 section, 8 hours after the CS. Participants who received drug prescription inflammatory or analgesic were submitted to the assessment and intervention after 6 and 8 hours, respectively, to minimise possible interactions between effects of drugs and TENS. | |
Outcomes | Pain score and adverse effect were evaluated immediately after, 20, 40 and 60 minutes after finalised treatment, using numerical rating scale (0‐10). | |
Notes | Funding sources: not mentioned. Setting: Santa Casa de Misericórdia and Hospital Estadual Dirceu Arcoverde (HEDA), Brazil. Conflicts of interest: not mentioned. Dates of trial: not mentioned, published 2014. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The participants were randomly allocated into 3 groups according to software. |
Allocation concealment (selection bias) | Low risk | The randomisation and allocation, hidden in opaque envelopes and numbered, were performed by a researcher no research participant. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | The participants were unaware of the treatment protocol to which each participant was allocated. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The assessor was unaware in treatment protocol to which each participant was allocated. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | There were losses which were not described. We contacted the author in 24 June 2015 with no response. |
Selective reporting (reporting bias) | Low risk | Presents the results of the analysis proposed in the methods. |
Other bias | Low risk | We do not suspect any other bias related to this study. |