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Efficacy 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
Universidad Católica San Antonio de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

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

0 Days - 90 Days (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 15, 2018
    Last Updated
    January 20, 2022
    Sponsor
    Universidad Católica San Antonio de Murcia
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    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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