A randomized controlled trial to compare alternative strategies for preventing infant crying and sleep problems in the first 12 weeks: the COSI study

Abstract This study aimed to investigate whether watching an educational video on infant crying and the dangers of shaking and smothering within 1 week after delivery at maternity wards reduces self-reported shaking and smothering, at a 1-month health checkup. A cluster randomized controlled trial, stratified by area and hospital function, was employed in 45 obstetrics hospitals/clinics in Osaka Prefecture, Japan. In the intervention group, mothers watched an educational video on infant crying and the dangers of shaking and smothering an infant, within 1 week of age, during hospitalization at maternity wards, without blinding on group allocation. Control group received usual care. A total of 4722 (N = 2350 and 2372 for intervention and control group, respectively) mothers who delivered their babies (still birth and gestational age < 22 weeks were excluded) between October 1, 2014, and January 31 were recruited. Outcomes were self-reported shaking and smothering behaviors, knowledge on infant crying and shaking, and behaviors to cope with infant crying, assessed via a questionnaire at a 1-month health checkup. In all, 2718 (N = 1078 and 1640) responded to the questionnaire (response rate: 58.3%), and analytic sample size was 2655 (N = 1058 and 1597 for intervention and control group, respectively). Multilevel analysis was used to adjust for correlation within the cluster. Prevalence of shaking was significantly lower in the intervention group (0.19%) than in the control group (1.69%). Intention-to-treat analysis showed an 89% reduction in the reported prevalence of self-reported shaking (OR: 0.11, 95% CI: 0.02–0.53) due to watching the educational video. However, self-reported smothering behavior showed no significant reduction (OR: 0.66, 95% CI: 0.27–1.60). No side effects were reported. Watching an educational video on infant crying and the dangers of shaking and smothering within 1 week after delivery at maternity wards reduced self-reported shaking at 1 month of age. UMIN Clinical Trial Registry UMIN000015558.

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Behavioral Interventions for Infant Sleep Problems: A Randomized Controlled Trial

PEDIATRICS ◽

10.1542/peds.2015-1486 ◽

2016 ◽

Vol 137 (6) ◽

pp. e20151486-e20151486 ◽

Cited By ~ 51

Author(s):

M. Gradisar ◽

K. Jackson ◽

N. J. Spurrier ◽

J. Gibson ◽

J. Whitham ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Behavioral Interventions ◽

Sleep Problems ◽

Controlled Trial ◽

Infant Sleep ◽

Randomized Controlled

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Efficacy of ear acupuncture on sleep quality in breast cancer survivors: A randomized controlled trial.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.12066 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. 12066-12066

Author(s):

Melanie Désirée Hoextermann ◽

Katja Buner ◽

Heidemarie Haller ◽

Wiebke Kohl ◽

Mattea Reinisch ◽

...

Keyword(s):

Breast Cancer ◽

Randomized Controlled Trial ◽

Sleep Quality ◽

Cancer Survivors ◽

Breast Cancer Survivors ◽

Sleep Problems ◽

Controlled Trial ◽

Ear Acupuncture ◽

Significant Group ◽

Randomized Controlled

12066 Background: Among females, breast cancer is the most commonly diagnosed cancer worldwide. Sleep problems impair 40 to 70 % of breast cancer survivors. The aim of this randomized controlled trial was to evaluate the effect of ear acupuncture on sleep quality in breast cancer survivors. Methods: Fifty-two female breast cancer survivors (mean age 55.73 ± 8.10) were randomized to either 10 treatments of ear acupuncture within five weeks (N = 26) or to a single session of psycho-education and given an advice booklet concerning insomnia (N = 26). Both interventions were delivered in a group setting. Primary outcome was sleep quality (measured by the Pittsburgh Sleep Quality Index) at week 5 corrected for treatment expectancies. Secondary outcomes were inflammation parameters (interleukin-6) at week 5, sleep quality at week 17, and stress, anxiety, depressive symptoms, quality of life and fatigue 5 weeks and 17 weeks after randomization. Results: Intention-to-treat analysis showed a significantly stronger increase of sleep quality in the ear acupuncture group compared to the psycho-education group ( p= .031; d = 0.64) at week 5. Furthermore, ear acupuncture improved stress ( p= .030; d = 0.64), anxiety ( p = .001; d = 0.97), and fatigue ( p = .012; d = 0.75) at week 5 compared to psycho-education. No significant group difference was found on any outcome at week 17. No serious adverse events occurred during the study period. Conclusions: Group ear acupuncture may be a helpful intervention in tackling sleep problems in breast cancer survivors in the short term and may reduce stress, anxiety and fatigue as well. Long-term effects remain questionable. Clinical trial information: NCT03874598 .

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