R10.4
Conditions
Interventions
Group 1: 3 osteopathic treatments within 3 weeks
Group 2: untreated (waiting list)
Sponsors
Akademie für Osteopathie e.V.
Eligibility
Sex/Gender
All
Age
1 Weeks to 3 Months
Inclusion criteria
Inclusion criteria: - Neuropediatric findings unremarkable, - Fulfillment of Rome IV criteria - Birth weight > 2500 - Informed consent and sufficient knowledge of the German language from at least one parent
Exclusion criteria
Exclusion criteria: - U2 or U3 examinations by the pediatrician must be performed and without findings that would preclude participation in the study - Infants will be excluded if they have active comorbidities that require medical treatment at the time of enrollment in the study (e.g., medication such as antibiotics, failure to thrive, GERD, gastrointestinal tract disorders, other etiologic predisposing factors for irritability) - In the event of acute fever (or acute illness), enrollment in the study will be postponed until symptoms have resolved - Physical therapy or manual treatment already in progress
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Do osteopathic treatments of infants with infantile colic/excessive crying (according to Rome IV criteria) have an impact on the subjectively perceived distress of the parents compared to routine care ("usual care")? measured with a visual analog scale (VAS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Recording of average daily crying time over 21 days (diary), total crying time over 21 days, crying intensity (NRS), parent survey: Satisfaction and confidence (Karitane confidence Scale), adverse event data. | — |
Countries
Germany
Contacts
Public ContactFlorian Schwerla
Akademie für Osteopathie e.V.
Outcome results
None listed