Interventional Practices and Their Effectiveness in Infants With İnfantyl Colic

NCT06299358 | Active Not Recruiting

• 1 other identifier: KMU_MPEPE_1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Nurse's Role; Infantile Colic

Keywords

İnfantyl colic; Neonatal; Pediatric Nurses

Outcome Measures

Primary Outcomes (4)

• 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

  Two weeks

• 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.

  Two weeks

• 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

  Two weeks

• 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.

  Two weeks

Study Arms (3)

Foot massage group

EXPERIMENTAL

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. 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.

Other: Foot massage

Mother heart sound group

EXPERIMENTAL

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. 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.

Other: Mother heart sound

Foot massage and mother heart sound group (mixed group)

EXPERIMENTAL

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.

Other: Foot massage and maternal heart sound

Interventions

Foot massage OTHER

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.

Foot massage group

Mother heart sound OTHER

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.

Mother heart sound group

Foot massage and maternal heart sound OTHER

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.

Foot massage and mother heart sound group (mixed group)

Eligibility Criteria

• Age: 2 Weeks - 16 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karamanoğlu Mehmetbey University: lead

Study Sites (1)

Karamanoglu Mehmetbey University

Karaman, Center, 70100, Turkey (Türkiye)

Location

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• Roma vakfı
• Roma vakfı
• Yıldız, S. ve Coşkun, P., (2023). Doğal ve Yapay Tatlandırıcıların Sağlık Açısından İncelenmesi. Sağlık Bilimlerinde Yenilikçi Çalışmalar, 775-791. (Online Kitap Bölümü, 41. bölüm

MeSH Terms

Conditions

Colic

Condition Hierarchy (Ancestors)

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

Study Officials

• Nejla CANBULAT ŞAHİNER, Professor

  Karamanoğlu Mehmetbey University Faculty of Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: March 7, 2024
• Study Start: November 6, 2023
• Primary Completion: August 15, 2024
• Study Completion: January 1, 2025
• Last Updated: March 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)