M Castejón-Castejón1, M A Murcia-González2, J L Martínez Gil3, J Todri4, M Suárez Rancel5, O Lena4, R Chillón-Martínez6. 1. Health Science PhD Program, UCAM Catholic University of Murcia, Campus de los Jerónimos nº135, Guadalupe 30107, Murcia, Spain. Electronic address: mccfisio@gmail.com. 2. Department of Physiotherapy, UCAM Catholic University of Murcia, Murcia, Spain. 3. HUVA Virgen Arrixaca, Murcia, Spain. 4. Health Science Department, UCAM Catholic University of Murcia, Murcia, Spain. 5. Departament of Mathematics, Statistics and Operations Research, University of La Laguna, Spain. 6. Faculty of Nursing, Physiotherapy and Podology, University of Seville, Seville, Spain.
Abstract
OBJECTIVES: To determine the effectiveness of Craniosacral Therapy (CST) for the treatment of infantile colic. MATERIAL AND METHODS: This randomized controlled trial was conducted on 58 infants, aged 0-84 days, diagnosed with infantile colic. The babies received a 30-40 minute CST session once a week (experimental group) or no treatment (control group). Babies in the CST group received either 1, 2 or 3 CST sessions over a 14-day period. Data were collected at 4 different times over the 24-day period, day 0 (baseline), day 7, day 14 and day 24. Crying (primary outcome) and sleep (secondary outcome) were evaluated using a crying and sleep diary, and colic severity was measured using the Infant Colic Severity Questionnaire (secondary outcome). RESULTS: There was a statistically significant difference between groups (CST and control) in crying hours (F = 188.47; p < 0.0005; η2 = 0.78), sleep hours (F = 61.20; p < 0.0005, η2 = 0.54) and colic severity (F = 143.74; p < 0.0005, η2 = 0.73) across all the time points. In comparison with the control group, CST babies reported significant and clinically relevant effects in crying hours on day 7 (-2.47 h (95%CI, -2.95 to -1.99); p < 0.0005; d = 1.73), on day 14 (-3.29 h (95%CI, -3.7 to -2.8); p < 0.0005; d = 2.87) and on day 24 (-3.20 h (95%CI, -3.7 to -2.6); p < 0.0005; d = 2.54); in sleep hours on day 7 (-2.47 h (95%CI, -2.95 to -1.99); p < 0.0005; d = 1.73) on day 14 (-3.29 h (95%CI, -3.7 to -2.8); p < 0.0005; d = 2.87) and on day 24 (-3.20 h (95%CI, -3.7 to -2.6); p < 0.0005; d = 2.54). CONCLUSIONS:Craniosacral therapy appears to be effective and safe for infantile colic by reducing the number of crying hours, the colic severity and increasing the total hours of sleep.
RCT Entities:
OBJECTIVES: To determine the effectiveness of Craniosacral Therapy (CST) for the treatment of infantile colic. MATERIAL AND METHODS: This randomized controlled trial was conducted on 58 infants, aged 0-84 days, diagnosed with infantile colic. The babies received a 30-40 minute CST session once a week (experimental group) or no treatment (control group). Babies in the CST group received either 1, 2 or 3 CST sessions over a 14-day period. Data were collected at 4 different times over the 24-day period, day 0 (baseline), day 7, day 14 and day 24. Crying (primary outcome) and sleep (secondary outcome) were evaluated using a crying and sleep diary, and colic severity was measured using the Infant Colic Severity Questionnaire (secondary outcome). RESULTS: There was a statistically significant difference between groups (CST and control) in crying hours (F = 188.47; p < 0.0005; η2 = 0.78), sleep hours (F = 61.20; p < 0.0005, η2 = 0.54) and colic severity (F = 143.74; p < 0.0005, η2 = 0.73) across all the time points. In comparison with the control group, CST babies reported significant and clinically relevant effects in crying hours on day 7 (-2.47 h (95%CI, -2.95 to -1.99); p < 0.0005; d = 1.73), on day 14 (-3.29 h (95%CI, -3.7 to -2.8); p < 0.0005; d = 2.87) and on day 24 (-3.20 h (95%CI, -3.7 to -2.6); p < 0.0005; d = 2.54); in sleep hours on day 7 (-2.47 h (95%CI, -2.95 to -1.99); p < 0.0005; d = 1.73) on day 14 (-3.29 h (95%CI, -3.7 to -2.8); p < 0.0005; d = 2.87) and on day 24 (-3.20 h (95%CI, -3.7 to -2.6); p < 0.0005; d = 2.54). CONCLUSIONS: Craniosacral therapy appears to be effective and safe for infantile colic by reducing the number of crying hours, the colic severity and increasing the total hours of sleep.