Ignite Creation Date:
2025-12-24 @ 12:55 PM
Ignite Modification Date:
2025-12-29 @ 3:04 AM
Study NCT ID:
NCT07207161
Status:
COMPLETED
Last Update Posted:
2025-10-03
First Post:
2025-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single-Session Physiotherapy Versus Massage in Premature Infants
Sponsor:
Necmettin Erbakan University
Organization:
Study Overview
Official Title:
The Comparison of the Effects of a Single-Session Physiotherapy Intervention and Massage in Premature Infants: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPIM-Preterm
Brief Summary:
This study investigates the effects of a single-session physiotherapy intervention compared to massage in premature infants hospitalized in the neonatal intensive care unit. Premature babies are vulnerable to stress, pain, and sleep disturbances due to medical procedures and the intensive care environment. The study aims to evaluate whether physiotherapy or massage can reduce stress and pain, improve sleep, bilirubin levels, and cerebral oxygenation. Infants will be randomly assigned to three groups: control (routine care), massage, and physiotherapy (Moyer-Mileur protocol). The results will contribute to developing evidence-based interventions to support the health and development of premature infants
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: