Jackson 2013.
| Methods | Randomised controlled trial | |
| Participants | 186 in‐hospital breastfeeding women who had given birth to a term infant and were within 4 days' postpartum. All women presented with complaints of nipple pain with signs of trauma. Excluded women with the following: 1. infant not expected to be discharged home with mother; 2. infant with congenital abnormalities that would impair breastfeeding, and 3. maternal allergy to lanolin Potential participants were identified by hospital staff nurses and were recruited from a large teaching hospital in Canada |
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| Interventions |
Intervention group: lanolin (n = 93): women were provided with a tube of lanolin and a handout with instructions for its use. Participants were instructed to wash their hands, and to then gently apply a pea‐sized amount of lanolin to the nipple and the areola following every feed until resolution of symptoms or the end of the intervention period Control group: usual care (n = 93): women were instructed to apply nothing to their nipples for the trial period |
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| Outcomes | 1. Nipple pain: maternal self report measured at initial assessment and at 4 and 7 days' post‐randomisation using a Numeric Rating Scale (0‐10) (primary outcome) Exploratory analyses (not included in the review) were completed with the Sensory Pain Rating Index (0‐33), Affective Pain Rating Index (0‐12), Total Pain Rating Index (0‐45), Present Pain Intensity (0‐5), and Short Form McGill Pain Questionnaire (0‐60) 2. Breastfeeding duration: measured at 4 and 12 weeks' postpartum by asking women if their infant received any breast milk during the past 24 hours 3. Breastfeeding exclusivity: measured at 4 and 12 weeks' postpartum using the levels of infant feeding suggested by Labbok 1990 4. Maternal satisfaction with treatment: measured at 12 weeks' postpartum using questions related to satisfaction with the effectiveness of the ointment. 1 item was rated on a 5‐point Likert‐type scale where 1 = definitely satisfied to 5 = definitely not satisfied |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Small pieces of paper were labelled either 'control group' or 'intervention group' and folded in half and then randomly placed in envelopes by a research assistant not involved in the trial |
| Allocation concealment (selection bias) | Low risk | Sequentially numbered, sealed, opaque envelopes |
| Blinding of participants and personnel (performance bias) wound healing | High risk | Participants could not be blinded to group allocation |
| Blinding of outcome assessment (detection bias) wound healing | Low risk | Research assistant blinded to group allocation collected outcome data |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 186 women were randomised of which data were available for 165 (88.7%) at 4 and 7 days' post‐randomisation, 162 (87.1%) at 4 weeks' postpartum, and 165 (88.7%) at 12 weeks' postpartum; 160 women completed the maternal satisfaction questionnaire at 12 weeks' postpartum |
| Selective reporting (reporting bias) | Low risk | Intention‐to‐treat analysis completed |
| Other bias | Low risk | None noted |