Back to resultsEfficacy of a Craniosacral Therapy Protocol in the Treatment of Infant Colic
Primary Purpose
Infant Conditions, Colic, Infantile, Gastro-Intestinal Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Manual treatment
Sponsored by
About this trial
This is an interventional treatment trial for Infant Conditions focused on measuring Skull, Osteopathic Manipulation, Infantile Colic, Clinical Trial, Massage, Infant, Osteopathic Medicine
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Craniosacral therapy
Parent information
Arm Description
Craniosacral therapy and parent information on how to manage colic.
Parent information on how to manage colic.
Outcomes
Primary Outcome Measures
Crying
Total amount of time the infant cries within a day. Crying is recorded by the parents in a diary. The higher the score is, the more hours of crying per day.
Secondary Outcome Measures
Sleep
Total amount of time the infant sleeps within a day. Sleep is recorded by the parents in a diary. The higher the score is, the more hours of sleep per day.
Severity-ICSQ
Severity of colic is measured according to a validated Infant Colic Severity Questionnaire. Minimum score is 24 and maximum 100. A score higher than 50 points suggests that the patient suffers from infantile colic.
Full Information
NCT ID
NCT03675763
First Posted
September 15, 2018
Last Updated
January 20, 2022
Sponsor
Universidad Católica San Antonio de Murcia
1. Study Identification
Unique Protocol Identification Number
NCT03675763
Brief Title
Efficacy of a Craniosacral Therapy Protocol in the Treatment of Infant Colic
Official Title
Efficacy of a Craniosacral Therapy Protocol in the Treatment of Infant Colic
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 2, 2015 (Actual)
Primary Completion Date
December 20, 2016 (Actual)
Study Completion Date
December 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Católica San Antonio de Murcia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant Conditions, Colic, Infantile, Gastro-Intestinal Disorder
Keywords
Skull, Osteopathic Manipulation, Infantile Colic, Clinical Trial, Massage, Infant, Osteopathic Medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Craniosacral therapy
Arm Type
Experimental
Arm Description
Craniosacral therapy and parent information on how to manage colic.
Arm Title
Parent information
Arm Type
No Intervention
Arm Description
Parent information on how to manage colic.
Intervention Type
Other
Intervention Name(s)
Manual treatment
Intervention Description
Craniosacral therapy protocol.
Primary Outcome Measure Information:
Title
Crying
Description
Total amount of time the infant cries within a day. Crying is recorded by the parents in a diary. The higher the score is, the more hours of crying per day.
Time Frame
Change from baseline crying at 24 days, also evaluated at days 7 and 14
Secondary Outcome Measure Information:
Title
Sleep
Description
Total amount of time the infant sleeps within a day. Sleep is recorded by the parents in a diary. The higher the score is, the more hours of sleep per day.
Time Frame
Change from baseline sleep at 24 days, also evaluated at days 7 and 14
Title
Severity-ICSQ
Description
Severity of colic is measured according to a validated Infant Colic Severity Questionnaire. Minimum score is 24 and maximum 100. A score higher than 50 points suggests that the patient suffers from infantile colic.
Time Frame
Change from baseline severity -ICSQ at 24 days, also evaluated at days 7 and 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
90 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of a Craniosacral Therapy Protocol in the Treatment of Infant Colic
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