NCT01852500

Are Newborns Conscious of the Placebo Effect? Result From an RCT in Osteopathy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: European Institute for Evidence Based Osteopathic Medicine · Academic / Other
• Sex: All
• Age: 29 Weeks – 37 Weeks
• Healthy volunteers: Accepted

Summary

Results from previous studies suggest the association between Osteopathic Manipulative Treatment (OMT) and length of stay (LOS) reduction in a population of preterm infants. The primary objective of the present study is to evaluate the effectiveness of sham OMT in reducing LOS in a sample of preterm newborns, in order to investigate whether previous clinical results could be related to a hypothetical placebo effect.

Conditions

• Prematurity

Interventions

Type	Name	Description
OTHER	Sham Osteopathic Manipulative Treatment	Patients from this group received sham osteopathic treatments twice a week for the entire length of stay in the unit.
OTHER	Standard care	Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2013-05-13
• Last updated: 2013-05-13

Locations

1 site across 1 country: Italy