Clinical Trial: The Effectiveness of the Manual Therapy on Infant Colic (MT-IF)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Effects of Visceral Manual Therapy on Infant Colic Symptoms. A Controlled Clinical Trial

Brief Summary: The main goal of this study is to get to know if applying manual therapy will reduce the infant colic symptoms for to improve quality of life of babies and parents.

Detailed Summary:

Background:

Infant colic is one of the most common disorders in the first year of baby´s life. It is estimated to affect between 10 to 40 % of healthy born children in their first year of life. To determine the effectiveness of a protocol manual therapy in the treatment of colic, using the Infant Colic Severity Questionnaire, we analyzed two intervention groups: experimental in which children received the protocol manual therapy and counseling to parents and the Control group, in which parents received advice only.

Objectives:

To assess the effectiveness of visceral manual therapy to improve the symptoms on infant colic.


Sponsor: University of Seville

Current Primary Outcome: Change from parents-reported infant colic severity at 3 weeks [ Time Frame: At the start of the study and one week after the second session (three weeks after the start of the study) ]

Evaluated by the infant colic severity scale


Original Primary Outcome: Same as current

Current Secondary Outcome: Change from parents-reported infant cry at 3 weeks [ Time Frame: At the start of the study and one week after the second session (three weeks after the start of the study) ]

Evaluated by cry-related items of the infant colic severity scale


Original Secondary Outcome: Same as current

Information By: University of Seville

Dates:
Date Received: March 29, 2016
Date Started: April 2016
Date Completion:
Last Updated: July 11, 2016
Last Verified: April 2016