Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT06299358
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Interventional Practices and Their Effectiveness in Infants With İnfantyl Colic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003085', 'term': 'Colic'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'In the study, interviews will be conducted at different times so that mothers or caregivers do not encounter mothers/caregivers in other groups. In this way, participant blinding will be ensured. Since the study will be conducted with newborns, no study will be conducted on other blinding techniques and biases. In order to prevent bias in the data evaluation process, each baby will be numbered by the researcher during the application and these numbers will be used by the statistical expert in statistical evaluations. The statistical expert will not learn the identity information of the participants and will only perform statistics according to the numbering.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Type and Purpose of the Study The study was designed as a randomized experimental study. Sample of the Study G\\* Power 3.1.9.7. program was used to calculate the sample size (Faul et al., 2007). As a result of the analysis, the sample size was calculated as 28 people for each of the three groups, and considering the possible data losses, it was decided to take 30 people for each group.\n\nIn the study, computer-aided randomization (random.org) program was used to determine the groups. Stratified randomization was preferred to ensure group similarity. In stratification, the number of weeks of age, gender and feeding patterns of the babies were used. After stratification, block randomization was used to decide which group the babies would be in.\n\nSPSS 22.0 package program will be used for data analysis.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-29', 'studyFirstSubmitDate': '2024-01-15', 'studyFirstSubmitQcDate': '2024-02-29', 'lastUpdatePostDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in colic scale ratings induced by maternal heart sound', 'timeFrame': 'Two weeks', 'description': 'The colic scale consists of 19 questions. The minimum score that can be obtained from the scale in total is 19 and the maximum score is 114. A score of 48 and above on the scale indicates the presence of colic.After 48 points, each point increase indicates an increase in the severity of colic'}, {'measure': 'Changes in comfort scale ratings as a result of maternal heart sound', 'timeFrame': 'Two weeks', 'description': 'The comfort scale consists of 6 sub-dimensions.Each sub-dimension is evaluated between 1 and 5 points. Comfort is considered good if the total score is 15 or above, and inadequate if it is below.'}, {'measure': 'Changes in colic scale assessments induced by foot massage', 'timeFrame': 'Two weeks', 'description': 'The colic scale consists of 19 questions. The minimum score that can be obtained from the scale in total is 19 and the maximum score is 114. A score of 48 and above on the scale indicates the presence of colic.After 48 points, each point increase indicates an increase in the severity of colic'}, {'measure': 'Changes in comfort scale assessments induced by foot massage', 'timeFrame': 'Two weeks', 'description': 'The comfort scale consists of 6 sub-dimensions.Each sub-dimension is evaluated between 1 and 5 points. Comfort is considered good if the total score is 15 or above, and inadequate if it is below.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['İnfantyl colic', 'Neonatal', 'Pediatric Nurses'], 'conditions': ["Nurse's Role", 'Infantile Colic']}, 'referencesModule': {'references': [{'pmid': '24848255', 'type': 'BACKGROUND', 'citation': 'Aagaard K, Ma J, Antony KM, Ganu R, Petrosino J, Versalovic J. The placenta harbors a unique microbiome. 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Int J Nurs Pract. 2012 Apr;18(2):164-9. doi: 10.1111/j.1440-172X.2012.02015.x.'}, {'pmid': '34627993', 'type': 'BACKGROUND', 'citation': 'Dos Reis Buzzo Zermiani AP, de Paula Soares ALPP, da Silva Guedes de Moura BL, Miguel ERA, Lopes LDG, de Carvalho Scharf Santana N, da Silva Santos T, Demarchi IG, Teixeira JJ. Evidence of Lactobacillus reuteri to reduce colic in breastfed babies: Systematic review and meta-analysis. Complement Ther Med. 2021 Dec;63:102781. doi: 10.1016/j.ctim.2021.102781. Epub 2021 Oct 7.'}, {'pmid': '27144617', 'type': 'BACKGROUND', 'citation': 'Drossman DA. Functional Gastrointestinal Disorders: History, Pathophysiology, Clinical Features and Rome IV. Gastroenterology. 2016 Feb 19:S0016-5085(16)00223-7. doi: 10.1053/j.gastro.2016.02.032. Online ahead of print.'}, {'pmid': '12811319', 'type': 'BACKGROUND', 'citation': 'Cirgin Ellett ML, Murphy D, Stroud L, Shelton RA, Sullivan A, Ellett SG, Ellett LD. Development and psychometric testing of the infant colic scale. Gastroenterol Nurs. 2003 May-Jun;26(3):96-103. doi: 10.1097/00001610-200305000-00002.'}, {'pmid': '22972642', 'type': 'BACKGROUND', 'citation': 'Gelfand AA, Thomas KC, Goadsby PJ. Before the headache: infant colic as an early life expression of migraine. Neurology. 2012 Sep 25;79(13):1392-6. doi: 10.1212/WNL.0b013e31826c1b7b. Epub 2012 Sep 12.'}, {'pmid': '31794639', 'type': 'BACKGROUND', 'citation': 'Gordon M, Gohil J, Banks SS. Parent training programmes for managing infantile colic. Cochrane Database Syst Rev. 2019 Dec 3;12(12):CD012459. doi: 10.1002/14651858.CD012459.pub2.'}, {'pmid': '16263986', 'type': 'BACKGROUND', 'citation': 'Hill DJ, Roy N, Heine RG, Hosking CS, Francis DE, Brown J, Speirs B, Sadowsky J, Carlin JB. Effect of a low-allergen maternal diet on colic among breastfed infants: a randomized, controlled trial. Pediatrics. 2005 Nov;116(5):e709-15. doi: 10.1542/peds.2005-0147.'}, {'pmid': '26447441', 'type': 'BACKGROUND', 'citation': 'Johnson JD, Cocker K, Chang E. Infantile Colic: Recognition and Treatment. Am Fam Physician. 2015 Oct 1;92(7):577-82.'}, {'pmid': '35352686', 'type': 'BACKGROUND', 'citation': 'Johnson JM, Adams ED. The Gastrointestinal Microbiome in Infant Colic: A Scoping Review. MCN Am J Matern Child Nurs. 2022 Jul-Aug 01;47(4):195-206. doi: 10.1097/NMC.0000000000000832.'}, {'type': 'BACKGROUND', 'citation': 'Kahraman, A., Başbakkal, Z. ve Yalaz, M., Validity and Reliability of the Newborn Comfort Behavior Scale. Journal of Nursing Research. 2014; 1: 1-11.'}, {'type': 'BACKGROUND', 'citation': 'Kanbir, O., Classical Massage, Treatment, Sports Massage, Classical Massage Rest, Ekin Publishing, 5th Edition, Bursa, 2015; 135-157.'}, {'pmid': '24559599', 'type': 'BACKGROUND', 'citation': 'Karakoc A, Turker F. Effects of white noise and holding on pain perception in newborns. Pain Manag Nurs. 2014 Dec;15(4):864-70. doi: 10.1016/j.pmn.2014.01.002. Epub 2014 Feb 20.'}, {'pmid': '16708044', 'type': 'BACKGROUND', 'citation': 'Keefe MR, Kajrlsen KA, Lobo ML, Kotzer AM, Dudley WN. Reducing parenting stress in families with irritable infants. Nurs Res. 2006 May-Jun;55(3):198-205. doi: 10.1097/00006199-200605000-00006.'}, {'pmid': '28092724', 'type': 'BACKGROUND', 'citation': "Koppen IJ, Nurko S, Saps M, Di Lorenzo C, Benninga MA. The pediatric Rome IV criteria: what's new? Expert Rev Gastroenterol Hepatol. 2017 Mar;11(3):193-201. doi: 10.1080/17474124.2017.1282820. Epub 2017 Jan 24."}, {'pmid': '32053826', 'type': 'BACKGROUND', 'citation': 'Korpela K, Renko M, Paalanne N, Vanni P, Salo J, Tejesvi M, Koivusaari P, Pokka T, Kaukola T, Pirttila AM, Tapiainen T. Microbiome of the first stool after birth and infantile colic. Pediatr Res. 2020 Nov;88(5):776-783. doi: 10.1038/s41390-020-0804-y. Epub 2020 Feb 13.'}, {'pmid': '30337035', 'type': 'BACKGROUND', 'citation': 'Mai T, Fatheree NY, Gleason W, Liu Y, Rhoads JM. Infantile Colic: New Insights into an Old Problem. Gastroenterol Clin North Am. 2018 Dec;47(4):829-844. doi: 10.1016/j.gtc.2018.07.008. Epub 2018 Sep 28.'}, {'pmid': '23979927', 'type': 'BACKGROUND', 'citation': 'McKenzie SA. Fifteen-minute consultation: Troublesome crying in infancy. Arch Dis Child Educ Pract Ed. 2013 Dec;98(6):209-11. doi: 10.1136/archdischild-2013-303903. Epub 2013 Aug 26.'}, {'pmid': '35922776', 'type': 'BACKGROUND', 'citation': 'Narang M, Shah D. Oral lactase for infantile colic: a randomized double-blind placebo-controlled trial. BMC Pediatr. 2022 Aug 3;22(1):468. doi: 10.1186/s12887-022-03531-8.'}, {'pmid': '31579772', 'type': 'BACKGROUND', 'citation': 'Obermayr F, Seitz G. Recent developments in cell-based ENS regeneration - a short review. Innov Surg Sci. 2018 Mar 9;3(2):93-99. doi: 10.1515/iss-2018-0005. eCollection 2018 Jun.'}, {'pmid': '31711532', 'type': 'BACKGROUND', 'citation': 'Perry R, Leach V, Penfold C, Davies P. An overview of systematic reviews of complementary and alternative therapies for infantile colic. Syst Rev. 2019 Nov 11;8(1):271. doi: 10.1186/s13643-019-1191-5.'}, {'pmid': '29941700', 'type': 'BACKGROUND', 'citation': 'Sarasu JM, Narang M, Shah D. Infantile Colic: An Update. Indian Pediatr. 2018 Nov 15;55(11):979-987. Epub 2018 Jun 13.'}, {'pmid': '27763733', 'type': 'BACKGROUND', 'citation': 'Savino F, Quartieri A, De Marco A, Garro M, Amaretti A, Raimondi S, Simone M, Rossi M. Comparison of formula-fed infants with and without colic revealed significant differences in total bacteria, Enterobacteriaceae and faecal ammonia. Acta Paediatr. 2017 Apr;106(4):573-578. doi: 10.1111/apa.13642. Epub 2016 Nov 15.'}, {'pmid': '28969887', 'type': 'BACKGROUND', 'citation': 'Savino F, Garro M, Montanari P, Galliano I, Bergallo M. Crying Time and RORgamma/FOXP3 Expression in Lactobacillus reuteri DSM17938-Treated Infants with Colic: A Randomized Trial. 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Epub 2021 Apr 12.'}, {'pmid': '28385295', 'type': 'BACKGROUND', 'citation': 'Wolke D, Bilgin A, Samara M. Systematic Review and Meta-Analysis: Fussing and Crying Durations and Prevalence of Colic in Infants. J Pediatr. 2017 Jun;185:55-61.e4. doi: 10.1016/j.jpeds.2017.02.020. Epub 2017 Apr 3.'}, {'pmid': '23319531', 'type': 'BACKGROUND', 'citation': 'de Weerth C, Fuentes S, Puylaert P, de Vos WM. Intestinal microbiota of infants with colic: development and specific signatures. Pediatrics. 2013 Feb;131(2):e550-8. doi: 10.1542/peds.2012-1449. Epub 2013 Jan 14.'}, {'pmid': '23941920', 'type': 'BACKGROUND', 'citation': 'de Weerth C, Fuentes S, de Vos WM. Crying in infants: on the possible role of intestinal microbiota in the development of colic. Gut Microbes. 2013 Sep-Oct;4(5):416-21. doi: 10.4161/gmic.26041. Epub 2013 Aug 9.'}, {'type': 'BACKGROUND', 'citation': "Yavaş, Çelik, M., Comparison of White Noise and Massage Application Methods in 0-12 Month Colicky Infants. Master's Thesis, Çukurova University Institute of Health Sciences, Adana. 2015."}, {'type': 'BACKGROUND', 'citation': 'Yavaş, Çelik, M. Infantile Colic and Nursing Approaches. Turkey Clinics, 2016; 8 (4), 335-342.'}, {'pmid': '21710185', 'type': 'BACKGROUND', 'citation': 'Iacovou M, Ralston RA, Muir J, Walker KZ, Truby H. Dietary management of infantile colic: a systematic review. Matern Child Health J. 2012 Aug;16(6):1319-31. doi: 10.1007/s10995-011-0842-5.'}, {'pmid': '28401050', 'type': 'BACKGROUND', 'citation': 'Zeevenhooven J, Koppen IJ, Benninga MA. The New Rome IV Criteria for Functional Gastrointestinal Disorders in Infants and Toddlers. Pediatr Gastroenterol Hepatol Nutr. 2017 Mar;20(1):1-13. doi: 10.5223/pghn.2017.20.1.1. Epub 2017 Mar 27.'}, {'pmid': '29760502', 'type': 'BACKGROUND', '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."}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3403674/', 'label': 'Alves, J.G.B., De Brito, R.C.C.M. ve Cavalcanti, T.S., (2012). Effectiveness of Mentha piperita in the Treatment of Infantile Colic: A Crossover Study. Evid Based Complement Alternat Med., 981352.'}, {'url': 'http://theromefoundation.org/rome-iv/rome-iv-criteria/', 'label': 'Roma vakfı'}, {'url': 'http://theromefoundation.org/rome-iv/whats-new-for-rome-iv/', 'label': 'Roma vakfı'}, {'url': 'https://scholar.google.com.tr/scholar?q=Do%C4%9Fal+ve+Yapay+Tatland%C4%B1r%C4%B1c%C4%B1lar%C4%B1n+Sa%C4%9Fl%C4%B1k+A%C3%A7%C4%B1s%C4%B1ndan+%C4%B0ncelenmesi&hl=tr&as_sdt=0&as_vis=1&oi=scholart', 'label': 'Yıldız, S. ve Coşkun, P., (2023). Doğal ve Yapay Tatlandırıcıların Sağlık Açısından İncelenmesi. Sağlık Bilimlerinde Yenilikçi Çalışmalar, 775-791. (Online Kitap Bölümü, 41. bölüm'}]}, 'descriptionModule': {'briefSummary': 'Infantile colic is a developmental disorder that reduces comfort levels in infants with intense crying crises and has negative effects on the infant and family. The study is planned to measure the effect of the combination of maternal heart sound simulation, aromatic foot massage and maternal heart sound simulation and aromatic foot massage on the colic and comfort levels of infants with infantile colic. It is aimed to alleviate colic symptoms, increase comfort levels, regulate daily crying and sleep durations (increase in sleep durations, decrease in crying durations) and support the development of infants in this context by using maternal heart sound simulation, aromatic foot massage and their combined application.', 'detailedDescription': "Infantile colic is a developmental disorder that occurs in the second week of extrauterine life, reaches its peak in the sixth week, continues up to four to six months, and negatively affects the infant and family in healthy infants who develop rapidly. Infantile colic is a very common disorder among functional gastrointestinal diseases. When the studies conducted to determine the prevalence of infantile colic are examined, it is seen that the prevalence varies according to the development level of the countries (prevalence increases as the development level decreases) and the average figures are %5-25.\n\nAlthough there are many studies on infantile colic, there is no clear acceptance about its etiology. Regarding the etiology of infantile colic; it is mentioned that gastrointestinal, psychosocial and immature central nervous system causes may be triggering in the disease. In addition, low birth weight, lactose intolerance, food allergy (cow's milk), hypersensitivity, excessive gas, increased peristalsis, bottle feeding, swallowing excess air during crying, gastroesophageal reflux, perception of distension as pain due to immature intestinal structure, incompatibility in serotonin and melatonin circadian rhythm in the first three months, as well as factors such as family stress, anxiety and psychosocial problems in the mother may play a role in the disease.\n\nIn functional gastrointestinal disorders, the lack of a structural, anatomical or biochemical impairment that can provide an objective assessment of the disease makes the diagnostic process difficult. Considering the lack of verbal expression in infants, it is essential to use certain accepted criteria in the diagnostic process in order to make an objective diagnosis of the disease. Due to these requirements, the Wessel technique and Rome II-III-IV criteria were used in the diagnostic process of infantile colic, respectively, and the use of Wessel, Rome III-IV is still ongoing. The first description of infantile colic in infants was made by Wessel (1954). Wessel defined infantile colic as crying for more than three hours a day, for more than three days a week and for more than three weeks without any developmental or situational discomfort. The first use of a child-specific FGID diagnosis was in the Rome II criteria in 1999. The use of Rome II criteria did not meet the need due to lack of literature and evidence. Therefore, with the publication of Rome III criteria in 2006, the diagnostic process became more objective. With the studies conducted over the years, Rome III diagnostic criteria were revised in 2006 and Rome IV diagnostic criteria were started to be used in order to better understand the diseases and provide the best treatment.\n\nAlthough there is no fixed treatment protocol in the treatment of infantile colic, pharmacological and non-pharmacological methods are used. Although pharmacological agents are occasionally used in treatment, dietary and behavioral treatment methods are mostly used in the treatment of the disease. Although pharmacologic treatment is occasionally used in infantile colic, studies do not support the use of any pharmacologic agent within the scope of evidence-based practice. In the pharmacologic treatment of infantile colic; Although drug groups such as anelgesics, antispasmolytics (especially simethicone, dicyclomine) and proton pump inhibitors are used, there is no evidence-based practice with usability because there is no specific treatment.\n\nSince the foods consumed by the mother may affect the baby through milk, it is recommended to temporarily exclude foods such as citrus fruits, eggs, cola, cow's milk, chocolate, dried legumes, nuts and dairy products from the mother's diet. Herbal teas may improve the symptoms of infantile colic and may also provide sedation, but caution should be exercised because the level of evidence is not sufficient. The use of probiotics is another method that may alleviate colic symptoms because it improves the intestinal microbiota, and the use of hydrolyzed formulas with prebiotics is recommended in infants fed formula.\n\nIn most FGIDs such as infantile colic, supportive therapies, therapeutic communication and approach techniques are prioritized. In FGIDs in infants, direct behavioral therapy methods are frequently used among non-pharmacological treatments and positive effects are reported. Direct behavioral therapy methods include sensorimotor stimulation (auditory stimuli, therapeutic touch, etc.), therapeutic massage, reflexology, not exposing the baby to excessive stimuli, rocking the baby or moving the baby in a car, kangaroo, etc. (kangaroo care), using a pacifier, applying warmth to the abdomen, swaddling the baby in a way that does not squeeze the baby, and warm baths. In addition to direct behavioral therapy methods, practices such as dietary changes, nutritional recommendations, glucose-sucrose applications, probiotic and herbal supplements, acupuncture and spinal manipulation to reduce the frequency and severity of infantile colic symptoms are also used in non-pharmacological treatment.\n\nMassage is the art of touch that concerns all or part of the body and creates a relaxing effect in the area where it is applied. Massage practice in infants also positively affects the baby's attachment process due to health, comfort of life and sensual contact. Massage application is an application that supports the coordination process with muscle stimulation and has positive effects on physical development, circulatory, respiratory and digestive systems. Massage, whose positive effects on colic symptoms are frequently emphasized in studies, also contributes to sleep duration as it also provides relaxation for the baby.\n\nTechniques such as euphlorage, petrissage, friction, vibration and percussion are used in massage application. In baby foot massage applications, euphlorage, petrissage and friction techniques are frequently preferred. Öfloraj; It is a patting movement applied towards the direction of venous circulation returning to the heart, which stimulates nerve, blood and lymph circulation, sweat and sebaceous glands by affecting the skin and subcutaneous tissues. Petrisage is a kneading movement applied by taking the subcutaneous tissue and muscles between the thumb and other fingers. It increases the circulation of the muscles and ensures the removal of metabolic waste products. Friction is a sliding and pressing movement applied to the body surface in small circles with fingertips in order to loosen the fluid accumulations in the skin and subcutaneous tissues with lymph circulation and stiffness around the joints.\n\nComfort is defined as the individual being comfortable, reducing stress and painful situations and making life easier. Comfort in newborns and infants includes indicators whose forms of expression differ from those of adults and are important in maintaining healthy development. Comfort indicators in newborns; Pulse and respiratory rate within normal limits and regularity Minimal body color changes Order in body movements Active use of behaviors that relax the newborn A healthy growth and development process It is defined as the realization of discharge as soon as possible. It is important for the sustainability of growth and development that babies are exposed to less pain and stress at birth. The pain experienced by babies in infantile colic creates distress for them and reduces the comfort level in both the baby and the family. Nursing is a special occupational group in which complementary, care-oriented practices are frequently used, based on holistic care philosophy, and caring about the support and sustainability of health. Nurses are the professionals who will perform these practices in complementary treatment. Nursing care applied systematically in infantile colic contributes to the health of the baby and family. A good family support programming, education, counseling, strengthening support factors and ensuring effective practices, implemented by taking all variables into consideration, will reduce the symptoms of infantile colic, while at the same time supporting infant and family attachment, spending more quality time and strengthening family ties, while reducing the frequency or severity of negative experiences that family members experience / may experience such as inadequacy and helplessness. Thus, family members will be helped to prevent/reduce psychological problems that may be seen due to infantile colic and the comfort of life will increase for both the baby and the family."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Weeks', 'minimumAge': '2 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Babies crying more than three hours a day, three days a week, according to the Wessel technique,\n* Babies are between 2 and 16 weeks postpartum,\n* The baby does not have any other illness that may cause restlessness and crying,\n* The baby does not have a chronic disease,\n* Absence of any anomaly in the foot area that would prevent massage,\n* Babies have passed the hearing test,\n* Babies do not have a problem that prevents hearing,\n* Infants are not receiving pharmacologic treatment for infantile colic,\n* Infants are not receiving non-pharmacologic treatment for infantile colic,\n* Babies are not receiving any pharmacologic (analgesic/sedative) treatment that may affect pain and comfort.\n\nExclusion and exclusion criteria:\n\n* Initiation of any pharmacologic treatment that may affect colic, comfort, sleep and crying times in infants included in the study,\n* Initiation of any non-pharmacologic treatment that may affect colic, comfort, sleep and crying times in infants included in the study,\n* Incomplete data.'}, 'identificationModule': {'nctId': 'NCT06299358', 'briefTitle': 'Interventional Practices and Their Effectiveness in Infants With İnfantyl Colic', 'organization': {'class': 'OTHER', 'fullName': 'Karamanoğlu Mehmetbey University'}, 'officialTitle': 'The Effect of Foot Massage and Maternal Heart Sound on Colic and Comfort Levels in Infants With Infantile Colic', 'orgStudyIdInfo': {'id': 'KMU_MPEPE_1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Foot massage group', 'description': "Foot massage will be performed by the researcher for 10 minutes on two consecutive days a week in the infants' own homes. In foot massage, euphlorage, petrisage and friction techniques will be used in the appropriate order.\n\nInfants in the foot massage group will be visited five times in total, two times each in the first encounter, first and second weeks. Related forms (Infantile colic and newborn comfort behavior scale) will be filled out by the researcher three times in total, once for the first encounter and once for each week. A total of two forms related to crying and sleep, one for each week, will be completed by the mother at the end of the study. The maternal state-trait anxiety scale will be completed twice, at the first encounter and at the end of the intervention.", 'interventionNames': ['Other: Foot massage']}, {'type': 'EXPERIMENTAL', 'label': 'Mother heart sound group', 'description': "For the group to listen to the mother's heart sounds, the heart sounds of the mothers of the babies will be recorded on an mp3 player in a quiet environment (in their own homes) with the help of hand-held doopes. The volume (65 decibels) and distance of the mp3 player will be determined by the researcher with the help of a decibel meter and the appropriate distance will be determined. The mother will play this sound to the infant for half an hour every day for two weeks, in coordination with the hours of the intervention in the other groups.\n\nThe infants in this group will be visited three times in total, once at the first encounter and once at the end of the first and second weekends, and the relevant forms (Infantile colic and newborn comfort behavior, state-trait anxiety scale) will be applied. Forms related to crying and sleep will be completed by the mother two times in total, one for each week.", 'interventionNames': ['Other: Mother heart sound']}, {'type': 'EXPERIMENTAL', 'label': 'Foot massage and mother heart sound group (mixed group)', 'description': "For the group in which maternal heart sounds and foot massage will be applied, the heart sounds of the mothers of the babies will be recorded on an mp3 player in a quiet environment (in their own homes) with the help of hand-held doopes. The sound (65 decibels) and distance of the mp3 player will be determined by the researcher with the help of a decibel meter. The researcher will perform foot massage as in the massage group and the mother's heart sound will be played for a total of half an hour with the massage. The infants in this group will be visited five times in total, once in the first encounter and twice each in the first and second week, and the relevant forms (Infantile colic, neonatal comfort behavior scales will be applied 3 times for infants; state-trait anxiety scale will be applied twice for the mother, once at the beginning and twice at the end). A total of two forms related to crying and sleep will be completed by the mother, one for each week.", 'interventionNames': ['Other: Foot massage and maternal heart sound']}], 'interventions': [{'name': 'Foot massage', 'type': 'OTHER', 'description': "Infants in the foot massage group will receive foot massage by the researcher on two consecutive days of the week for a total of four times. The massage will be performed in accordance with the specified application steps for 10 minutes just before the baby's restlessness starts.", 'armGroupLabels': ['Foot massage group']}, {'name': 'Mother heart sound', 'type': 'OTHER', 'description': "The sound recorded by the researcher under appropriate conditions will be played to the babies in the maternal heart sound group from an appropriate distance. The sound will be played a total of four times, on two consecutive days of the week, just before the baby's restlessness begins and for half an hour.", 'armGroupLabels': ['Mother heart sound group']}, {'name': 'Foot massage and maternal heart sound', 'type': 'OTHER', 'description': "Infants in the foot massage and maternal heart sound group will receive foot massage by the researcher on two consecutive days of the week for a total of four times. The massage will be performed in accordance with the specified application steps for 10 minutes just before the baby's restlessness starts. From the beginning of the massage, the pre-recorded maternal heart sound will be played to the infant for 30 minutes from an appropriate distance.", 'armGroupLabels': ['Foot massage and mother heart sound group (mixed group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70100', 'city': 'Karaman', 'state': 'Center', 'country': 'Turkey (Türkiye)', 'facility': 'Karamanoglu Mehmetbey University', 'geoPoint': {'lat': 37.18111, 'lon': 33.215}}], 'overallOfficials': [{'name': 'Nejla CANBULAT ŞAHİNER, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Karamanoğlu Mehmetbey University Faculty of Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The study is a doctoral thesis and the data collection process is ongoing. For this reason, it is planned to share only the title until the study is finalized and the whole study at the end of the study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karamanoğlu Mehmetbey University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Meltem Pepe', 'investigatorAffiliation': 'Karamanoğlu Mehmetbey University'}}}}