Supportive Care Training Given to Mothers of Babies With Infants Colic

NCT06197100 | Unknown

• 1 other identifier: AhiEvranU-UTubaKOÇ-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mothers; Infantile Colic

Keywords

infant; Infantile Colic; support intervention; mothers; Breast Feeding; crying baby

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

supportive care training

EXPERIMENTAL

Training in supportive care will be given to the experimental group (Training group). The mothers will also receive a training booklet from the researchers. The training booklet covers burping newborns, massage, and nourishment for mothers. In addition, mothers will be observed nursing their children, and appropriate breastfeeding instruction will be given if the baby's holding position is a problem. Over the course of a week, the supportive care training intervention will be given in three modules to the experimental group. The interventions will be carried out by the first investigator, a pediatric nursing specialist.

Other: Supportive care training

control groups

ACTIVE COMPARATOR

An educational pamphlet regarding mother-baby nutrition and how to soothe a crying infant will be distributed to mothers in the control group.

Other: control grups

Interventions

Supportive care training OTHER

The program includes breastfeeding teaching, baby massage, managing gas issues (shaking, white noise), and nutrition for mothers.

Also known as: The researcher will conduct training with the supporting training group and provide them with a booklet that they have created.

supportive care training

control grups OTHER

Mothers in this group will be given an educational brochure containing information about colic.

Also known as: educational brochure

control groups

Eligibility Criteria

• Age: 1 Month - 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

Study Sites (1)

Kirsehir Ahi Evran University

Kirşehi̇r, 40100, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 34704296 BACKGROUND

• 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.

  PMID: 32150292 BACKGROUND

• 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.

  PMID: 33848417 BACKGROUND

• 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.

  PMID: 29760502 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 29961271 BACKGROUND

• 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.

  PMID: 30865287 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Colic; Breast Feeding

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Child Health and Diseases Nursing Department President

Model Details: there are three sections to it, and they will all be finished simultaneously. This is not a study of drugs or devices. The two arms of the study are Supportive care training, and control groups.

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 9, 2024
• Study Start: March 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: January 9, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)