CompletedNot Applicable

Efficacy of a Craniosacral Therapy Protocol in the Treatment of Infant Colic

58 participantsStarted 2015-03-02

Plain-language summary

This is a randomised controlled trial that aims to determine the effectiveness of craniosacral therapy for the treatment of infantile colic. Manual therapy was applied to a group of young infants diagnosed with colic while a second group did not received any treatment.

Who can participate

Age range

0 Days – 90 Days

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 diagnosed with colic, * with 0-90 days of age, * who have had 3 hours of unexplainable crying per day for at least 3 days during the week previous to the study. Exclusion criteria: * infants diagnosed with any sort of pathological illness, allergies or food intolerance * who have suffered any intracranial hemorrhages or skull fractures.

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

Crying

Timeframe: Change from baseline crying at 24 days, also evaluated at days 7 and 14

Trial details

NCT IDNCT03675763

SponsorUniversidad Católica San Antonio de Murcia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-12-20

View on ClinicalTrials.gov More Infant Conditions trials

Who can participate

Age range

0 Days – 90 Days

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.