Single-Session Physiotherapy Versus Massage in Premature Infants

NCT07207161 | Completed

• 1 other identifier: 23090
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Preterm Infants

Keywords

Premature Infants; Physiotherapy; Infant Massage

Outcome Measures

Primary Outcomes (5)

• Change in Neonatal Infant Stress Scale (NISS)

  Change in Neonatal Infant Stress Scale (NISS, range 0-2; higher scores indicate greater stress) before and after the intervention.

  Pre-intervention to 30 minutes post-intervention

• Change in Neonatal Infant Pain Scale(NIPS)

  Change in Neonatal Infant Pain Scale (NIPS, range 0-7; higher scores indicate more pain) before and after the intervention.

  Pre-intervention to 30 minutes post-intervention

• Change in Total Sleep Duration (Brief Infant Sleep Questionnaire)

  Total sleep duration will be assessed using the Brief Infant Sleep Questionnaire (BISQ). Parents will be asked to report the infant's sleep pattern, and the total amount of time (in minutes) the infant sleeps during a 24-hour period will be recorded. The comparison will be made between pre-intervention and post-intervention data to evaluate whether the intervention has an effect on the infant's overall sleep time. A longer total sleep duration will be interpreted as an improvement in sleep quality.

  Baseline (pre-intervention) and within 24 hours after the intervention

• Change in Number of Night Awakenings (Brief Infant Sleep Questionnaire)

  Night awakenings will be assessed using the Brief Infant Sleep Questionnaire (BISQ). Parents will record the number of times the infant wakes up during the night within a typical 24-hour period. The data will be collected before and after the intervention to determine whether the procedure reduces the frequency of nighttime awakenings. A decrease in the number of awakenings will be considered as an indicator of improved sleep continuity and quality.

  Baseline (pre-intervention) and within 24 hours after the intervention

• Change in Sleep Onset Latency (Brief Infant Sleep Questionnaire)

  Sleep onset latency (the time it takes for the infant to fall asleep) will be measured using the Brief Infant Sleep Questionnaire (BISQ). Parents will report the average duration (in minutes) from when the infant is put to bed until the infant falls asleep. Comparisons will be made between pre-intervention and post-intervention values. A shorter sleep onset latency will be interpreted as a positive outcome, suggesting that the intervention may help infants fall asleep more quickly.

  Baseline (pre-intervention) and within 24 hours after the intervention

Secondary Outcomes (2)

• Change in Oxygen Saturation (SpO₂-peripheral oxygen saturation)

  15 minutes before intervention, 5 minutes during intervention, and 15 minutes after intervention

• Change in Heart Rate

  15 minutes before intervention, 5 minutes during intervention, and 15 minutes after intervention

Study Arms (3)

Control Group

NO INTERVENTION

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.

Massage Group

EXPERIMENTAL

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.

Behavioral: Infant Massage

Physiotherapy Group

EXPERIMENTAL

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.

Behavioral: Physiotherapy (Moyer-Mileur Protocol)

Interventions

Infant Massage BEHAVIORAL

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

Massage Group

Physiotherapy (Moyer-Mileur Protocol) 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.

Physiotherapy Group

Eligibility Criteria

• Age: 0 Days - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Nezahat Keleşoğlu Faculty of Health Sciences

Konya, Meram, 42090, Turkey (Türkiye)

Location

Related Links

• Related Info

MeSH Terms

Conditions

Premature Birth

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Neslihan Altuntaş Yılmaz

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Neither participants, care providers, investigators, nor outcome assessors are blinded to group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: October 3, 2025
• Study Start: February 13, 2025
• Primary Completion: May 2, 2025
• Study Completion: September 1, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)