Vimala Massage Infantile Colic, Sleep and Development Levels (NCT06993701) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Vimala Massage Infantile Colic, Sleep and Development Levels
Turkey (Türkiye)72 participantsStarted 2025-06-01
Plain-language summary
Objective: The effect of Vimala massage applied by parents on infantile colic, sleep and developmental levels of infants will be investigated.
Method: The data of the randomised controlled study is planned to be conducted in 3 Family Health Centres in Kilis province between 01 Jun 2025-01 January 2026. The population of the study will consist of infants diagnosed with IC who come to the FHC centre for diagnosis, treatment or follow-up between the specified dates and meet the inclusion criteria.
Who can participate
Age range
1 Month – 3 Months
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:
* Infants born at term (38-42 weeks of gestation)
* Aged between 1 and 3 months
* Birth weight between 2500 and 4500 grams
* No health problems other than infantile colic
* Growth and development percentile consistent with current age
* Diagnosed with infantile colic according to Rome IV criteria
* Not yet started any treatment for infantile colic
* No presence of diarrhea or constipation
* Parents with at least primary school education
* Able to speak and write in Turkish
* Provided written and verbal informed consent
* Volunteered to participate in the study
Exclusion Criteria:
Exclusion Criteria:
* Infants and parents who do not meet the inclusion criteria
* Infants with acute or chronic medical conditions (e.g., congenital anomalies, metabolic disorders)
* Infants currently receiving any pharmacological or complementary treatment for infantile colic
* Parents with communication difficulties or cognitive impairments that hinder comprehension of study procedures
* Parents who have previously participated in a similar infant massage or infantile colic intervention study
* Parents who are unable or unwilling to complete follow-up assessments or study procedures
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.