An interventional study of Osteopathy manual therapy and Measures to support and education to the family in Infantile Colic and Manual Therapy, sponsored by Universidad de Almeria. Completed at 1 site in Spain. Open to participants aged 3 Weeks to 6 Weeks. Per ClinicalTrials.gov, last updated 2020-11-13.
Sponsored by Universidad de Almeria · Not applicable, Interventional, and Treatment
This study compares the effectiveness of manual therapy (osteopathy) on infant colic versus education to the family, and a third group with no specific intervention.
Infant colic is a problem that affects 10-30% of babies in their first months of life. This research project aims to verify the effectiveness of manual therapy on infant colic. The sample is divided in three groups, performing in the firts one osteopathy manual therapy; in the second one, measures to support and education to the family; and in the third, there is no specific intervention.
127 studies on the registry are indexed under Colic; 18 are open to participants now.
This study's enrollment of 120 is above the median of 76 across 110 interventional studies indexed under Colic.
Browse Colic studies →Universidad de Almeria is the lead sponsor of 72 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Osteopathy manual therapy applying the following treatment: Technique for the treatment of parasympathetic innervation, Techniques for the treatment of sympathetic innervation of the digestive system, Functional visceral techniques.
Other: Osteopathy manual therapy
Measures to support and education to the family that consist on pedagogical intervention in parents, health education.
Behavioral: Measures to support and education to the family
No specific intervention, prescriptions by pediatrician
Technique for the treatment of parasympathetic innervation, Techniques for the treatment of sympathetic innervation of the digestive system, Functional visceral techniques.
Pedagogical intervention in parents and health education
Change from baseline FCL Questionnaire at 12 weeks of infants' life.
FCL (Fisioterapia en el Cólico del Lactante) QUESTIONNAIRE: Infant colic assessment questionnaire. Group CTS (Ciencias y Técnicas de la Salud) 305 of the University of Seville.
Time frame: At baseline, at 4 weeks, at 8 weeks, at 12 weeks of infants' life and at 3 months of infants' life
Maternal stress in the last month.
Perceived Stress Questionnaire (PSQ).
Time frame: At baseline and at 12 weeks of infants' life.
Intensity of irritability
Analogue visual scale from 0 to 6.
Time frame: At baseline and at 12 weeks of infants' life
Ran from Jan 2017 to primary completion in Jun 2020, 41 months.
Of 32 non-industry interventional studies with no phase under Colic, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 40. This study's 41 months is above that.
Counting every sponsor, half of 44 studies reached it within 21 months; a quarter within 10 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Universidad de Almeria