protocolSection identificationModule nctId: NCT06299358, orgStudyIdInfo id: KMU_MPEPE_1, briefTitle: Interventional Practices and Their Effectiveness in Infants With İnfantyl Colic, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-11-06, primaryCompletionDateStruct date: 2024-08-15, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Karamanoğlu Mehmetbey University, class: OTHER, 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., conditionsModule conditions: Nurse's Role, conditions: Infantile Colic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, 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.In 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.SPSS 22.0 package program will be used for data analysis., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, 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., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Foot massage, interventions name: Mother heart sound, interventions name: Foot massage and maternal heart sound, outcomesModule primaryOutcomes measure: Changes in colic scale ratings induced by maternal heart sound, primaryOutcomes measure: Changes in comfort scale ratings as a result of maternal heart sound, primaryOutcomes measure: Changes in colic scale assessments induced by foot massage, primaryOutcomes measure: Changes in comfort scale assessments induced by foot massage, eligibilityModule sex: ALL, minimumAge: 2 Weeks, maximumAge: 16 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: Karamanoglu Mehmetbey University, city: Karaman, state: Center, zip: 70100, country: Turkey, geoPoint lat: 37.18111, lon: 33.215, hasResults: False