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Effect of digital step counter feedback on mobility after cesarean delivery: a randomized controlled trial |
Ganer Herman H, Kleiner I, Tairy D, Gonen N, Ben Zvi M, Kovo M, Bar J, Weiner E |
Obstetrics and Gynecology 2020 Jun;135(6):1345-1352 |
clinical trial |
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: To assess the effect of a personalized repeated feedback approach using digital step counters (pedometers) on mobility after cesarean delivery in high-risk patients. METHODS: This was a randomized controlled trial at a tertiary university hospital. Patients who underwent cesarean delivery and were defined as high risk for thromboembolic events were asked to wear a pedometer around their wrists postpartum for 48 hours. Patients were randomized to the feedback group, which received personalized feedback by the research staff regarding their mobility at three set timepoints, or the control group, which received standard care. The number of steps taken by patients was compared between the groups and served as the primary outcome. Secondary outcomes included patient reported pain, physical and mental recovery, and overall satisfaction. Sample size was predetermined to detect a 25% between-group difference in the primary outcome. RESULTS: From December 2018 to July 2019, 215 patients were recruited, randomized and completed follow-up -- 108 in the feedback group and 107 in the control group. Patients' demographics and intrapartum course were similar between the groups. The number of steps taken was significantly higher in the feedback group compared with the control group: 5,918 +/- 3,116 versus 4,161 +/- 2,532 steps, p < 0.001. Pain scores were similar between the groups, as was analgesic consumption. Patients in the feedback group reported a significantly easier physical and mental postpartum recovery and were significantly more satisfied with their delivery experience. Postpartum complications did not differ between the groups. CONCLUSION: In high-risk patients after cesarean delivery, mobility was improved by using a personalized feedback approach. Enhanced mobility was not associated with a higher rate of complications or pain and was positively associated with patient satisfaction. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT03724760.
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