Preterm InfantsSPIM-PretermNCT07207161
Single-Session Physiotherapy Versus Massage in Premature Infants
A study testing Infant Massage and Physiotherapy (Moyer-Mileur Protocol) in people with Preterm Infants, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days to 1 month
- Conditions the study is for
- Preterm Infants
- What is being tested?
- Infant Massage and Physiotherapy (Moyer-Mileur Protocol)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Feb 2025to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Nezahat Keleşoğlu Faculty of Health Sciences
Konya, Meram, 42090
About this study
Official title: 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
- Conditions
- Preterm Infants
- Being tested
- Infant Massage, Physiotherapy (Moyer-Mileur Protocol)
- Keywords
- Premature Infants, Physiotherapy, Infant Massage
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant MassageBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Physiotherapy (Moyer-Mileur Protocol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (pre-intervention) and within 24 hours after the intervention
Secondary outcomes (2)
Change in Oxygen Saturation (SpO₂-peripheral oxygen saturation)
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.
Measured: 15 minutes before intervention, 5 minutes during intervention, and 15 minutes after intervention
Change in Heart Rate
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.
Measured: 15 minutes before intervention, 5 minutes during intervention, and 15 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start13 Feb 2025
- Primary completion2 May 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantsStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyma Atalar, Necmettin Erbakan University
- Investigators
- Neslihan Altuntaş Yılmaz, Study director, Necmettin Erbakan University Nezahat Keleşoğlu Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207161
- Sponsor's protocol ID
- 23090
- Acronym
- SPIM-Preterm
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of the Effects of a Single-Session Physiotherapy Intervention and Massage in Premature Infants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07207161
- Acronym / sponsor ID
- SPIM-Preterm / 23090
- Conditions
- Preterm Infants
- Keywords
- Premature Infants, Physiotherapy, Infant Massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 2 May 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Infant MassageInfants 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. |
| Physiotherapy Group | Experimental | Behavioral: Physiotherapy (Moyer-Mileur Protocol)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. |
Who may qualify
- Ages
- 0 days to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infant MassageA standardized infant massage protocol applied by a physiotherapist, including gentle tactile stimulation to promote growth, relaxation, and neuromuscular development in premature infants. | Behavioural | Massage Group |
| 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. | Behavioural | Physiotherapy Group |
Primary outcome
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.
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.
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.
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.
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.
2 secondary outcomes
Change in Oxygen Saturation (SpO₂-peripheral oxygen saturation)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Preterm Infants
Not yet recruiting
Effects of a Multisensory Intervention Program on the Term Behavior of the Very Premature Baby
Very Premature Baby
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neslihan Altuntaş Yılmaz study director
Necmettin Erbakan University Nezahat Keleşoğlu Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant Massage and Physiotherapy (Moyer-Mileur Protocol) in people with Preterm Infants, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Neonatal Infant Stress Scale (NISS) (time frame: Pre-intervention to 30 minutes post-intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.