Infantile Colic Clinical Trial
Official title:
Effectiveness of Supportive Care Training Given to Mothers of Babies With Infant Colic: Randomized Controlled Study
Verified date | December 2023 |
Source | Kirsehir Ahi Evran Universitesi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Infantile Colic is a non-pathological condition that causes babies to cry excessively throughout their first few months of life. It has a prevalence of 15-30% and is defined by excessive sobbing for at least 3 hours per day, 3 days per week for around 3 weeks. Excessive sobbing, blushing, parachroma around the lips, bloating in the abdomen, drawing the legs into the abdomen, coldness at the ends, and fisting of the hands are all symptoms of infantile colic. Another significant clinical aspect of Infantile Colic is its protracted, difficult to soothe, and inexplicable nature. Infantile Colic is thought to have a cicadian pain cycle that begins in the evening. Infantile Colic is a non-pathological condition that causes babies to cry excessively throughout their first few months of life. It has a prevalence of 15-30% and is defined by excessive sobbing for at least 3 hours per day, 3 days per week for around 3 weeks. Excessive sobbing, blushing, parachroma around the lips, bloating in the abdomen, drawing the legs into the abdomen, coldness at the ends, and fisting of the hands are all symptoms of infantile colic. Another significant clinical aspect of Infantile Colic is its protracted, difficult to soothe, and inexplicable nature. Infantile Colic is thought to have a cicadian pain cycle that begins in the evening. Anxiety and stress that arise during the postpartum period cause a variety of issues in both the mother and the baby, and have a negative impact on the mother-baby bond as well as the mother's care and parenting skills. Sleep deprivation, sleep disturbance, and exhaustion are said to be caused by the sensation of not being able to meet the child's demands. It has been found that as parental stress levels rise, the gut flora deteriorates, and increasing cortisol in breast milk increases the baby's crying attacks. Colic and excessive crying are also risk factors for unfavorable parent-infant interactions. Infantile Colic has been shown to have a negative impact on children's health in the short and long term for all of these reasons. As a result, healthcare experts must devise therapies to lessen the painful impact of Infantile Colic on babies and their families. As a result, the purpose of this study was to see how supportive care training for parents affected the colic levels of babies with Infantile Colic, as well as mothers' perceptions of nursing and parental self-efficacy.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | September 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Month to 3 Months |
Eligibility | Inclusion Criteria: - Gestational week >37, birth weight >2500g, - No congenital anomalies related to the digestive system or nutrition, - Postnatal age of 1-3 months, - Not receiving colic treatment, - Diagnosed with Infantile colic by a pediatrician, - Babies who are exclusively breastfed, - Mothers of these babies who are over 18 years old, do not use sedative or antiepileptic drugs, can understand and communicate in Turkish, have no mental disabilities, and volunteer to participate in the study will be included in the research. Exclusion Criteria: - Gestational week = 37 and birth weight = 2500g, - Those with metabolic disease and congenital anomalies of the digestive system, - treated for colic, - not breastfed, - Babies whose postnatal age is less than 1 month and more than 3 months |
Country | Name | City | State |
---|---|---|---|
Turkey | Kirsehir Ahi Evran University | Kirsehi?r |
Lead Sponsor | Collaborator |
---|---|
Kirsehir Ahi Evran Universitesi |
Turkey,
Despriee AW, Magi CO, Smastuen MC, Glavin K, Nordhagen L, Jonassen CM, Rehbinder EM, Nordlund B, Soderhall C, Carlsen KL, Skjerven HO. Prevalence and perinatal risk factors of parent-reported colic, abdominal pain and other pain or discomforts in infants until 3 months of age - A prospective cohort study in PreventADALL. J Clin Nurs. 2022 Oct;31(19-20):2784-2796. doi: 10.1111/jocn.16097. Epub 2021 Oct 26. — View Citation
Hatch M, Landy K. Do parent training programs reduce crying time in infants with and without colic? Evidence-Based Pract. 2022;25(6):16-7.
Hechler C, Beijers R, Riksen-Walraven JM, de Weerth C. Are cortisol concentrations in human breast milk associated with infant crying? Dev Psychobiol. 2018 Sep;60(6):639-650. doi: 10.1002/dev.21761. Epub 2018 Jul 1. — View Citation
Hjern A, Lindblom K, Reuter A, Silfverdal SA. A systematic review of prevention and treatment of infantile colic. Acta Paediatr. 2020 Sep;109(9):1733-1744. doi: 10.1111/apa.15247. Epub 2020 Jun 2. — View Citation
Khajeh M, Sadeghi T, Ramezani M, Derafshi R. Effect of mothers' educational supportive care program on pain intensity and crying duration caused by colic pain in infants aged 1-5 months. Evid Based Care J. 2019;9(1):7-15.
Ong TG, Gordon M, Banks SS, Thomas MR, Akobeng AK. Probiotics to prevent infantile colic. Cochrane Database Syst Rev. 2019 Mar 13;3(3):CD012473. doi: 10.1002/14651858.CD012473.pub2. — View Citation
Shirazinia R, Golabchifar AA, Fazeli MR. Efficacy of probiotics for managing infantile colic due to their anti-inflammatory properties: a meta-analysis and systematic review. Clin Exp Pediatr. 2021 Dec;64(12):642-651. doi: 10.3345/cep.2020.01676. Epub 2021 Apr 12. — View Citation
Zeevenhooven J, Browne PD, L'Hoir MP, de Weerth C, Benninga MA. Infant colic: mechanisms and management. Nat Rev Gastroenterol Hepatol. 2018 Aug;15(8):479-496. doi: 10.1038/s41575-018-0008-7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Breastfeeding Self-efficacy | Breastfeeding Self-efficacy Scale: It is a scale consisting of 33 items developed by Dennis (1999). It consists of two sub-dimensions to determine mothers' breastfeeding skills, beliefs and behaviors regarding breastfeeding. | before intervention/15 days after the intervention | |
Primary | Perceived Maternal Parenting Self-Efficacy | Perceived Maternal Parenting Self-Efficacy Scale: It was created in 2007 by Barnes and Adamson-Macedo to assess the degree of self-efficacy among women who had babies early. The scale yields a minimum of 18 points and a maximum of 72 points. A rise in the score signifies an increase in the mother's degree of self-efficacy. | before intervention/15 days after the intervention | |
Primary | Infant Colic | The Infant Colic Scale was developed in 2002 by Marsha L. Cirgin Ellet and her colleagues to assist healthcare professionals in diagnosing and evaluating colic. The scale consists of 5 sub-dimensions and 22 questions: Cow's milk/soy protein allergy/intolerance, immature digestive system, immature central nervous system, difficult baby, parent-infant interaction + problem baby. | before intervention/15 days after the intervention |
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