Effect of Osteopathic Manipulative Treatment on Pain in Preterms
NCT ID: NCT02146677
Last Updated: 2015-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2014-06-30
2015-09-30
Brief Summary
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OMT was extensively used to treat, prevent and manage pain symptoms. Numerous research was published addressing acute and chronic pain in different medical conditions. However, no trials were carried out on pain in newborns. The aim of the present clinical trial is to explore the effectiveness of OMT in reducing pain in a sample of preterm infants.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sham
newborns will be osteopathically evaluated and softly touched
Sham therapy
Usual care
Usual care
newborns will be undergone usual routine neonatology care
Usual care
OMT
newborns will receive osteopathic evaluation and treatment according to international guidelines. Osteopathic treatment use will be indirect techniques.
Osteopathic manipulative treatment
Usual care
Interventions
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Osteopathic manipulative treatment
Sham therapy
Usual care
Eligibility Criteria
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Inclusion Criteria
* written informed consent by parents or legal guardians
* preterms born in the same hospital
Exclusion Criteria
* genetic disorders
* congenital disorders
* cardiovascular abnormalities
* proven or suspected necrotized enterocolitis with or without gastrointestinal perforation
* proven or suspected abdominal obstruction
* pre/post surgery patients
* pneumoperitoneum
* atelectasis
* Newborn from an HIV seropositive/drug addicted mother
* respiratory disorders
* transferred to/from other hospital
* admitted for preterminal comfort care (defined as neither intubation nor cardio-respiratory resuscitation)
26 Weeks
37 Weeks
ALL
No
Sponsors
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European Institute for Evidence Based Osteopathic Medicine
OTHER
Responsible Party
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Locations
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Pescara Civil Hospital
Pescara, PE, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Cerritelli F, Cicchitti L, Martelli M, Barlafante G, Renzetti C, Pizzolorusso G, Lupacchini M, D'Orazio M, Marinelli B, Cozzolino V, Fusilli P, D'Incecco C. Osteopathic manipulative treatment and pain in preterms: study protocol for a randomised controlled trial. Trials. 2015 Mar 8;16:84. doi: 10.1186/s13063-015-0615-3.
Other Identifiers
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NEO-Pa 1
Identifier Type: -
Identifier Source: org_study_id
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