UnknownNot Applicable

Interventional Practices and Their Effectiveness in Infants With İnfantyl Colic

Turkey (Türkiye)90 participantsStarted 2023-11-06

Plain-language 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.

Who can participate

Age range

2 Weeks – 16 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in colic scale ratings induced by maternal heart sound

Timeframe: Two weeks

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

Timeframe: Two weeks

Changes in colic scale assessments induced by foot massage

Timeframe: Two weeks

Changes in comfort scale assessments induced by foot massage

Timeframe: Two weeks

Trial details

NCT IDNCT06299358

SponsorKaramanoğlu Mehmetbey University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-15

View on ClinicalTrials.gov More Nurse's Role trials

Plain-language summary

Who can participate

Age range

2 Weeks – 16 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Changes in colic scale ratings induced by maternal heart sound

Timeframe: Two weeks

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

Timeframe: Two weeks

Changes in colic scale assessments induced by foot massage

Timeframe: Two weeks

Changes in comfort scale assessments induced by foot massage

Timeframe: Two weeks