Promoting self-management of breast and nipple pain in breastfeeding women: Protocol of a pilot randomized controlled trial.
Ruth Lucas, Katherine Bernier, Mallory Perry and 5 others
PMID 30835887WHAT IT FOUND
Nurse-led texts and educational modules were acceptable to breastfeeding women, but paper journals were burdensome and many did not return them.
The paper reports feasibility and acceptability lessons, not tested effects on pain.
Key findings
01Women overall responded well to nurse-led texts and did not find them invasive, but many did not complete or return the paper breastfeeding journal.
02Recruitment reached 65 women, with 33 in the control group and 32 in the intervention group, meeting the target of 60 women with complete data, and five intervention-group women did not complete.
03The pilot planned estimation rather than formal testing of intervention effects.
STILL TO COME
How it was doneWhat they foundWhat it means for RNs
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What it does not show
This is a protocol and pilot feasibility study, not a completed trial of clinical outcomes. The analyses were planned to estimate effects rather than test whether the intervention worked. Sixty-five women were recruited to reach a target of 60 with complete data, and five intervention-group women did not complete. Baseline data collection was burdensome for women and clinical staff, and paper journal completion was poor. The intervention included educational modules, cognitive restructuring, nurse-led texting, a paper journal, and online resources together, so the contribution of any single component cannot be separated. The control group was usual care or attention control, so comparisons are with routine support, not with an isolated component.
Declared interests
The authors declared no conflicts of interest. The article is listed as supported by NIH and non-U.S. government sources.
The easy way to misread this
Do not read the positive response to nurse-led texts as evidence that the intervention reduces breast or nipple pain. The pilot planned estimation rather than testing of intervention effects.