Single-Session Physiotherapy Versus Massage in Premature Infants (SPIM-Preterm)

October 2, 2025 updated by: Seyma Atalar, Necmettin Erbakan University

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Meram
      • Konya, Meram, Turkey (Türkiye), 42090
        • Nezahat Keleşoğlu Faculty of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: 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.
Experimental: 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.
Behavioral: 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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Pre-intervention to 30 minutes post-intervention
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.
Pre-intervention to 30 minutes post-intervention
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.
Baseline (pre-intervention) and within 24 hours after the intervention
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.
Baseline (pre-intervention) and within 24 hours after the intervention
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.
Baseline (pre-intervention) and within 24 hours after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
15 minutes before intervention, 5 minutes during intervention, and 15 minutes after intervention
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.
15 minutes before intervention, 5 minutes during intervention, and 15 minutes after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Necmettin Erbakan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Neslihan Altuntaş Yılmaz, Necmettin Erbakan University Nezahat Keleşoğlu Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 13, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 2, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 3, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23090

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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