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Completed

NCT Number: NCT07207161

Single-Session Physiotherapy Versus Massage in Premature Infants

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

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Key information

Age range

0 day–1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nezahat Keleşoğlu Faculty of Health Sciences

Konya, Meram, 42090, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Neonatal Infant Stress Scale (NISS)

    Time frame: Pre-intervention to 30 minutes post-intervention

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

  2. Change in Neonatal Infant Pain Scale(NIPS)

    Time frame: Pre-intervention to 30 minutes post-intervention

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

  3. Change in Total Sleep Duration (Brief Infant Sleep Questionnaire)

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

    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.

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

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

    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.

  5. Change in Sleep Onset Latency (Brief Infant Sleep Questionnaire)

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

    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.

Secondary outcomes

  1. Change in Oxygen Saturation (SpO₂-peripheral oxygen saturation)

    Time frame: 15 minutes before intervention, 5 minutes during intervention, and 15 minutes after intervention

    Oxygen saturation (SpO₂, measured in percentage) will be assessed to evaluate respiratory stability in premature infants during and after the intervention. Measurements will be recorded at three time points: (1) 15 minutes before the intervention (baseline), (2) at the 5th minute during the intervention, and (3) 15 minutes after the intervention. Higher oxygen saturation values (closer to 95-100%) will be considered favorable, indicating improved or maintained oxygenation.

  2. Change in Heart Rate

    Time frame: 15 minutes before intervention, 5 minutes during intervention, and 15 minutes after intervention

    Heart rate (beats per minute) will be measured to assess physiological changes in premature infants following the intervention. Measurements will be taken at three distinct time points: (1) 15 minutes before the intervention (baseline), (2) during the intervention at the 5th minute, and (3) 15 minutes after the intervention. The purpose of this outcome is to determine whether the intervention has an effect on autonomic stability, as reflected by heart rate variability. A decrease in heart rate or stabilization within the normal neonatal range will be considered a favorable outcome.

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Official study title

The Comparison of the Effects of a Single-Session Physiotherapy Intervention and Massage in Premature Infants: A Randomized Controlled Trial

Acronym: SPIM-Preterm

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 3, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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