Clinical trial NCT06299358: Interventional Practices and Their Effectiveness in Infants With İnfantyl Colic
Official title: The Effect of Foot Massage and Maternal Heart Sound on Colic and Comfort Levels in Infants With Infantile Colic
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Nurse's Role
Infantile Colic
Keywords: İnfantyl colic
Neonatal
Pediatric Nurses
Lead sponsor: Karamanoğlu Mehmetbey University
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 90
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Although 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.

In 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.

Although 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.

Since 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.

In 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.

Massage 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.

Techniques 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.

Comfort 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.

Eligibility criteria: Inclusion criteria:

* Babies crying more than three hours a day, three days a week, according to the Wessel technique,
* Babies are between 2 and 16 weeks postpartum,
* The baby does not have any other illness that may cause restlessness and crying,
* The baby does not have a chronic disease,
* Absence of any anomaly in the foot area that would prevent massage,
* Babies have passed the hearing test,
* Babies do not have a problem that prevents hearing,
* Infants are not receiving pharmacologic treatment for infantile colic,
* Infants are not receiving non-pharmacologic treatment for infantile colic,
* Babies are not receiving any pharmacologic (analgesic/sedative) treatment that may affect pain and comfort.

Exclusion and exclusion criteria:

* Initiation of any pharmacologic treatment that may affect colic, comfort, sleep and crying times in infants included in the study,
* Initiation of any non-pharmacologic treatment that may affect colic, comfort, sleep and crying times in infants included in the study,
* Incomplete data.

Primary outcomes:
measure: Changes in colic scale ratings induced by maternal heart sound
timeFrame: Two weeks
measure: Changes in comfort scale ratings as a result of maternal heart sound
timeFrame: Two weeks
measure: Changes in colic scale assessments induced by foot massage
timeFrame: Two weeks
measure: Changes in comfort scale assessments induced by foot massage
timeFrame: Two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karamanoglu Mehmetbey University
state: Center
Study officials:
affiliation: Karamanoğlu Mehmetbey University Faculty of Health Sciences
name: Nejla CANBULAT ŞAHİNER, Professor
role: STUDY_DIRECTOR
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