Single-Session Physiotherapy Versus Massage in Premature Infants

NCT ID: NCT07207161

Last Updated: 2025-10-03

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-13

Study Completion Date

2025-09-01

Brief Summary

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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

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Conditions

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Preterm Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study uses a parallel assignment model with three groups. Premature infants are randomly allocated to one of three arms: (1) Control group receiving routine neonatal care, (2) Massage group receiving infant massage, and (3) Physiotherapy group receiving a single-session physiotherapy intervention based on the Moyer-Mileur protocol.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

This is an open-label study. Neither participants, care providers, investigators, nor outcome assessors are blinded to group allocation.

Study Groups

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Control Group

Infants in this group will receive routine neonatal intensive care without any additional physiotherapy or massage intervention. This arm serves as the standard care control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Massage Group

Infants in this group will receive infant massage as an intervention. Massage will be performed by a trained physiotherapist following a standardized protocol. The purpose is to evaluate the effects of massage on physiological stability, weight gain, and overall development in premature infants.

Group Type EXPERIMENTAL

Infant Massage

Intervention Type BEHAVIORAL

A standardized infant massage protocol applied by a physiotherapist, including gentle tactile stimulation to promote growth, relaxation, and neuromuscular development in premature infants.

Physiotherapy Group

Infants in this group will receive a single-session physiotherapy intervention based on the Moyer-Mileur protocol. The intervention includes gentle range of motion and flexion-extension exercises designed to stimulate neuromuscular development in premature infants. The effects will be compared with those of massage and routine neonatal care.

Group Type EXPERIMENTAL

Physiotherapy (Moyer-Mileur Protocol)

Intervention Type BEHAVIORAL

A single-session physiotherapy intervention consisting of gentle range of motion and flexion-extension exercises following the Moyer-Mileur protocol to stimulate musculoskeletal and neuromotor development in premature infants.

Interventions

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Infant Massage

A standardized infant massage protocol applied by a physiotherapist, including gentle tactile stimulation to promote growth, relaxation, and neuromuscular development in premature infants.

Intervention Type BEHAVIORAL

Physiotherapy (Moyer-Mileur Protocol)

A single-session physiotherapy intervention consisting of gentle range of motion and flexion-extension exercises following the Moyer-Mileur protocol to stimulate musculoskeletal and neuromotor development in premature infants.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Preterm infants born between 20 and 37 gestational weeks

Apgar score ≥ 4 at the 5th minute after birth

Parental consent obtained for participation

Infants able to receive oxygen via CPAP (Continuous Positive Airway Pressure) or nasal prongs during the intervention if necessary

Exclusion Criteria

Congenital anomalies or chromosomal abnormalities

Chronic medical conditions such as bronchopulmonary dysplasia

Intraventricular hemorrhage grade III or IV (IVH)

Necrotizing enterocolitis (NEC)

Asphyxia or seizures
Minimum Eligible Age

0 Days

Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Necmettin Erbakan University

OTHER

Sponsor Role lead

Responsible Party

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Seyma Atalar

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Neslihan Altuntaş Yılmaz

Role: STUDY_DIRECTOR

Necmettin Erbakan University Nezahat Keleşoğlu Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Locations

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Nezahat Keleşoğlu Faculty of Health Sciences

Konya, Meram, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Related Links

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Other Identifiers

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23090

Identifier Type: -

Identifier Source: org_study_id

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