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Osteopathic manipulative treatment and pain in preterms: study protocol for a randomised controlled trial
Francesco Cerritelli1,2, Luca Cicchitti3,4, Marta Martelli5,6
1Clinical-based Human Research Department, C.O.ME. Collaboration, Via Amerigo Vespucci 188, 65126, Pescara, Italy. francesco.cerritelli@gmail.com.
Trials
|April 16, 2015
Summary
This study investigates osteopathic manipulative treatment (OMT) for pain reduction in preterm newborns. Results will inform OMT
Area of Science:
- Neonatal care
- Pain management
- Osteopathic manipulative treatment
Background:
- Evidence indicates a need for improved pain management in newborns.
- Osteopathic manipulative treatment (OMT) is used for painful conditions in newborns.
- Previous studies show OMT can reduce hospital stay and costs, but its effect on newborn pain is unstudied.
Purpose of the Study:
- To explore the effectiveness of osteopathic manipulative treatment (OMT) in reducing pain in preterm newborns.
- To evaluate potential advantages of OMT in neonatal pain management.
Main Methods:
- A three-armed, single-blinded, placebo-controlled randomized trial involving 120 preterm newborns.
- Participants were randomized into study (OMT), sham (soft touch), and control groups.
- The primary outcome was the change in the Premature Infant Pain Profile (PIPP) questionnaire scores; secondary outcomes included length of stay and costs.
Main Results:
- This section is not available in the provided abstract.
Conclusions:
- This clinical trial protocol is designed to assess the benefits of OMT for pain in preterm infants.
- The study adopts a patient-centered approach, focusing on the overall benefit of osteopathic care.
