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Nurse's RoleNCT06299358

Interventional Practices and Their Effectiveness in Infants With İnfantyl Colic

A study testing Foot massage, Mother heart sound and Foot massage and maternal heart sound in people with Nurse's Role and Infantile Colic, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 2 to 16 weeks
Conditions the study is for
Nurse's Role, Infantile Colic
What is being tested?
Foot massage, Mother heart sound and Foot massage and maternal heart sound
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteTurkey (Türkiye)
Study dates
6 Nov 2023to 1 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 16 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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,
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Karamanoglu Mehmetbey University

    Karaman, Center, 70100

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Foot Massage and Maternal Heart Sound on Colic and Comfort Levels in Infants With Infantile Colic

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.

Read the 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.

Being tested
Foot massage, Mother heart sound, Foot massage and maternal heart sound
Keywords
İnfantyl colic, Neonatal, Pediatric Nurses
Medical subject headings
Colic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Foot massageOther

    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.

  • Mother heart soundOther

    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.

  • Foot massage and maternal heart soundOther

    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.

Study groups in NCT06299358
Study groupRoleWhat they receive
Foot massage groupExperimentalFoot 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. Infants 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.
Receives: Other: Foot massage
Mother heart sound groupExperimentalFor 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. The 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.
Receives: Other: Mother heart sound
Foot massage and mother heart sound group (mixed group)ExperimentalFor 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.
Receives: Other: Foot massage and maternal heart sound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in colic scale ratings induced by maternal heart sound

    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

    Measured: Two weeks

  2. Changes in comfort scale ratings as a result of maternal heart sound

    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.

    Measured: Two weeks

  3. Changes in colic scale assessments induced by foot massage

    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

    Measured: Two weeks

  4. Changes in comfort scale assessments induced by foot massage

    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.

    Measured: Two weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2024
  2. Study start6 Nov 2023
  3. Primary completion15 Aug 2024 (estimated)
  4. Study completion1 Jan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06299358
Sponsor's protocol ID
KMU_MPEPE_1
Status last verified
Feb 2024
First submitted
15 Jan 2024
Last updated
7 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Aagaard K, Ma J, Antony KM, Ganu R, Petrosino J, Versalovic J. The placenta harbors a unique microbiome. Sci Transl Med. 2014 May 21;6(237):237ra65. doi: 10.1126/scitranslmed.3008599.

    PubMed 24848255
  • Ahmed M, Billoo AG, Iqbal K, Memon A. Clinical Efficacy Of Lactase Enzyme Supplement In Infant Colic: A Randomised Controlled Trial. J Pak Med Assoc. 2018 Dec;68(12):1744-1747.

    PubMed 30504935
  • Baldassarre ME, Di Mauro A, Mastromarino P, Fanelli M, Martinelli D, Urbano F, Capobianco D, Laforgia N. Administration of a Multi-Strain Probiotic Product to Women in the Perinatal Period Differentially Affects the Breast Milk Cytokine Profile and May Have Beneficial Effects on Neonatal Gastrointestinal Functional Symptoms. A Randomized Clinical Trial. Nutrients. 2016 Oct 27;8(11):677. doi: 10.3390/nu8110677.

    PubMed 27801789
  • Bellaiche M, Ategbo S, Krumholz F, Ludwig T, Miqdady M, Abkari A, Vandenplas Y. A large-scale study to describe the prevalence, characteristics and management of functional gastrointestinal disorders in African infants. Acta Paediatr. 2020 Nov;109(11):2366-2373. doi: 10.1111/apa.15248. Epub 2020 Mar 18.

    PubMed 32150302
  • Benninga MA, Faure C, Hyman PE, St James Roberts I, Schechter NL, Nurko S. Childhood Functional Gastrointestinal Disorders: Neonate/Toddler. Gastroenterology. 2016 Feb 15:S0016-5085(16)00182-7. doi: 10.1053/j.gastro.2016.02.016. Online ahead of print.

    PubMed 27144631
  • Chogle A, Velasco-Benitez CA, Koppen IJ, Moreno JE, Ramirez Hernandez CR, Saps M. A Population-Based Study on the Epidemiology of Functional Gastrointestinal Disorders in Young Children. J Pediatr. 2016 Dec;179:139-143.e1. doi: 10.1016/j.jpeds.2016.08.095. Epub 2016 Oct 7.

    PubMed 27726867
  • Coughlin M, Gibbins S, Hoath S. Core measures for developmentally supportive care in neonatal intensive care units: theory, precedence and practice. J Adv Nurs. 2009 Oct;65(10):2239-48. doi: 10.1111/j.1365-2648.2009.05052.x.

    PubMed 19686402
  • Çelik, H.İ., Elbasan, B., Gücüyener, K., Kayıhan, H. ve Huri, M., Investigation of Sensory Processing Skills in Preterm and Term Infants. Physiotherapy Rehabilitation, 2018; 29 (2): 31-36. doi: 10.21653/tjpr.343255.

  • Cetinkaya B, Basbakkal Z. A validity and reliability study investigating the Turkish version of the Infant Colic Scale. Gastroenterol Nurs. 2007 Mar-Apr;30(2):84-90; discussion 90. doi: 10.1097/01.SGA.0000267925.31803.30.

    PubMed 17440307
  • Cetinkaya B, Basbakkal Z. The effectiveness of aromatherapy massage using lavender oil as a treatment for infantile colic. Int J Nurs Pract. 2012 Apr;18(2):164-9. doi: 10.1111/j.1440-172X.2012.02015.x.

    PubMed 22435980
  • 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.

    PubMed 34627993
  • 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.

    PubMed 27144617
  • 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.

    PubMed 12811319
  • 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.

    PubMed 22972642
  • 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.

    PubMed 31794639

Questions about this trial

What is this clinical trial studying?

A study testing Foot massage, Mother heart sound and Foot massage and maternal heart sound in people with Nurse's Role and Infantile Colic, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in colic scale ratings induced by maternal heart sound (time frame: Two weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06299358, which also lists 43 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.

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