OsteopathyNCT06967870
The Effect of Cranial Osteopathy Intervention in Preterm Babies
A study testing Osteopathic intervention and Home based exercise education in people with Osteopathy and PreTerm Neonate, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
There are planing to have 2 groups of premature born cases. Each group will include 15 cases. Participants are need to be 28-37 weeks born and no older than post term 6 weeks. All cases are going to be evaluated. Home based exercise plan is going to be explained. Read more about this study
- Who is it for?
- Ages 1 week to 6 weeksHealthy volunteers can take part
- Conditions the study is for
- Osteopathy, PreTerm Neonate, Sensory Profiles
- What is being tested?
- Osteopathic intervention and Home based exercise education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2025to 8 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 week to 6 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Premature birth (<37 weeks)
- Corrected age <6 weeks.
- Discharged to home
- Stable condition
- Family agrees to continue home program
Who cannot join
- Having a congenital cyanotic heart problem,
- Being born earlier than 28 weeks,
- The family not accepting to participate in the study,
- Neglecting check-ups and sessions,
- Using a respiratory appliance,
- Presence of craniosynostosis,
- Being included in another physiotherapy program during the study period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Cranial Osteopathy Intervention on Sensory Profile, Sleep Quality, Colic Symptoms and Motor Movements in Preterm Babies
There are planing to have 2 groups of premature born cases. Each group will include 15 cases. Participants are need to be 28-37 weeks born and no older than post term 6 weeks. All cases are going to be evaluated. Home based exercise plan is going to be explained. The experimental group is going to take 6 osteopathic sessions weekly. After 6 weeks cases are going to be evaluated again.
Read the detailed description
Babies born at or before the 37th week of pregnancy are defined as preterm babies. While the number of premature babies has increased in recent years, the survival rates of preterm babies have also increased with the development of neonatal intensive care units. Neurodevelopmental problems can be seen at a higher rate in premature babies compared to term babies. In preterm births, birth occurs at critical stages of brain and nervous system development in the baby. It has been stated in the literature that even late preterm babies may experience problems in sensory processing and regulation stages. The addition of factors such as neonatal intensive care history to preterm birth causes them to score even lower in terms of sensory profile compared to term babies. It has been stated that preterm babies are in the high-risk group in terms of sensory processing problems. In a systematic review conducted in 2019, it was stated that premature babies and children have sensory modulation problems at a rate of 28-87%; sensory processing problems at a rate of 9-70%, and sensory-based motor processing problems at a rate of 20-70%.
Colic in babies; It is a condition characterized by sudden, persistent and restless crying in a generally healthy situation. Abdominal bloating and irritability often accompany the crying. It is difficult for the baby to calm down and fall asleep.Although the etiopathogenesis of colic in the neonatal period has not been fully determined, it has been stated that the underdeveloped nervous system, gastrointestinal system and stress factors are triggers. Studies have shown that the frequency of colic increases as the baby's gestational age decreases.
Sleep is the primary activity of the developing brain in early life, so it is not surprising that sleep plays a very important role in brain development. The existence of a sleep-wake cycle, sleep architecture and the percentage of the 24-hour period spent sleeping in the neonatal period have been associated with neurodevelopmental outcomes.
The importance of early intervention in preterm babies is emphasized in the literature. Although there are no protocol-determined intervention methods for babies in the developmental risk group, it has been recommended to start developmental intervention as early as possible. Osteopathic manual therapy applications consist of drug-free, non-invasive, and manually applied methods. They are important methods used to contribute to the health of babies. The focus is on tissue tensions that occur especially in the cranial regions of babies. There are a limited number of studies in the literature on the effectiveness of cranial osteopathic applications. No study has been found on the effect of cranial osteopathy on the sensory profile of the baby. Although there are studies evaluating the relationship between the baby's sleep quality and colic symptoms, different results have been obtained. This study was planned to contribute to the literature by investigating the effect of cranial osteopathy on the sensory profile, sleep quality and colic symptoms in premature babies. In the study, in addition to obtaining evidence-based data on cranial osteopathic applications, it was aimed to examine the effects on the sensory profile, sleep quality, colic symptoms and motor performance of preterm babies.
- Conditions
- Osteopathy, PreTerm Neonate, Sensory Profiles, Colic, Sleep Quality, Motor Development of Premature Infants
- Being tested
- Osteopathic intervention, Home based exercise education
- Keywords
- manual therapy, premature, sensory integration, early intervention, cranial
- Medical subject headings
- Colic, Sleep Initiation and Maintenance Disorders, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic interventionOther
Researcher will use osteopathic techniques on cranial area includes light touch.
Home based exercises will be show on cases and demand to do exercise regularly
Home based exercise educationOther
Home based exercises will be show on cases and demand to do exercise regularly.
| Study group | Role | What they receive |
|---|---|---|
| Osteopathy intervention group | Experimental | Beginning of the project assesment will be made, home exercises are going to be explained and said to continue exercises every day. Cases in this group will take 6 osteopathy sessions weekly. After 6 weeks assesment will be made again. Receives: Other: Osteopathic intervention; Other: Home based exercise education |
| Home based exercises group | Active comparator | Beginning of the project assesment will be made, home exercises are going to be explained and said to continue exercises every day. After 6 weeks assesment will be made again. Receives: Other: Home based exercise education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test of Infant Motor Performance
The test is a motor outcome measure designed to assess posture and selective control of movement in infants for functional performance in daily life. The test consists of 31 items in standard format, 28 of which are made by observing spontaneous activities and scoring them as pass or fail. Getting higher points means better motor control.
Measured: 6 weeks
Secondary outcomes (3)
Assessment of General Movements
This is a diagnostic tool for the functional assessment of the young nervous system. General Movements is a diagnostic tool based on visual gestalt perception of videoed agespecific normal or abnormal general movements. Motor Optimality Scores < = 23 at 14-16 weeks of corrected age are predictive of motor, cognitive, and neurosensory motor impairment, and scores <=15 are predictive of CP.
Measured: 6 weeks
The Infant Colic Scale
This Scale was developed to help diagnose colic. The scale has a total of 22 items in 5 subscales. Cow's milk/soy protein allergy/intolerance, immature gastrointestinal system, immature central nervous system, difficult baby temperament, parent-baby interaction-problem baby. Infant colic scale items are evaluated over 6 points. Likert-type scale is used. Low score is an indicator of colic
Measured: 6 weeks
Brief Infant Sleep Questionnaire
It is a questionnaire that provides objective measurement of infant sleep. It has 13 items. It is an assessment form regarding sleep patterns, sleep ecology and parents' sleep perceptions of babies aged 0-36 months. The questionnaire includes specific items about the baby's day and night sleep patterns as well as sleep-related behaviors and parental perception.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start5 May 2025 (estimated)
- Primary completion28 Aug 2025 (estimated)
- Study completion8 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopathyStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eylem TÜTÜN YÜMİN, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967870
- Sponsor's protocol ID
- AIBU-FTR-ETY-04
- Status last verified
- May 2025
- First submitted
- 3 Mar 2025
- Last updated
- 13 May 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 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cranial Osteopathy Intervention on Sensory Profile, Sleep Quality, Colic Symptoms and Motor Movements in Preterm Babies
- ClinicalTrials.gov ID
- NCT06967870
- Acronym / sponsor ID
- AIBU-FTR-ETY-04
- Conditions
- Osteopathy, PreTerm Neonate, Sensory Profiles, Colic, Sleep Quality, Motor Development of Premature Infants
- Keywords
- manual therapy, premature, sensory integration, early intervention, cranial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 5 May 2025 (estimated)
- Primary completion
- 28 Aug 2025 (estimated)
- Study completion
- 8 Oct 2025 (estimated)
- First posted
- 13 May 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.
There are planing to have 2 groups of premature born cases. Each group will include 15 cases. Participants are need to be 28-37 weeks born and no older than post term 6 weeks. All cases are going to be evaluated. Home based exercise plan is going to be explained. The experimental group is going to take 6 osteopathic sessions weekly. After 6 weeks cases are going to be evaluated again.
Detailed description
Babies born at or before the 37th week of pregnancy are defined as preterm babies. While the number of premature babies has increased in recent years, the survival rates of preterm babies have also increased with the development of neonatal intensive care units. Neurodevelopmental problems can be seen at a higher rate in premature babies compared to term babies. In preterm births, birth occurs at critical stages of brain and nervous system development in the baby. It has been stated in the literature that even late preterm babies may experience problems in sensory processing and regulation stages. The addition of factors such as neonatal intensive care history to preterm birth causes them to score even lower in terms of sensory profile compared to term babies. It has been stated that preterm babies are in the high-risk group in terms of sensory processing problems. In a systematic review conducted in 2019, it was stated that premature babies and children have sensory modulation problems at a rate of 28-87%; sensory processing problems at a rate of 9-70%, and sensory-based motor processing problems at a rate of 20-70%.
Colic in babies; It is a condition characterized by sudden, persistent and restless crying in a generally healthy situation. Abdominal bloating and irritability often accompany the crying. It is difficult for the baby to calm down and fall asleep.Although the etiopathogenesis of colic in the neonatal period has not been fully determined, it has been stated that the underdeveloped nervous system, gastrointestinal system and stress factors are triggers. Studies have shown that the frequency of colic increases as the baby's gestational age decreases.
Sleep is the primary activity of the developing brain in early life, so it is not surprising that sleep plays a very important role in brain development. The existence of a sleep-wake cycle, sleep architecture and the percentage of the 24-hour period spent sleeping in the neonatal period have been associated with neurodevelopmental outcomes.
The importance of early intervention in preterm babies is emphasized in the literature. Although there are no protocol-determined intervention methods for babies in the developmental risk group, it has been recommended to start developmental intervention as early as possible. Osteopathic manual therapy applications consist of drug-free, non-invasive, and manually applied methods. They are important methods used to contribute to the health of babies. The focus is on tissue tensions that occur especially in the cranial regions of babies. There are a limited number of studies in the literature on the effectiveness of cranial osteopathic applications. No study has been found on the effect of cranial osteopathy on the sensory profile of the baby. Although there are studies evaluating the relationship between the baby's sleep quality and colic symptoms, different results have been obtained. This study was planned to contribute to the literature by investigating the effect of cranial osteopathy on the sensory profile, sleep quality and colic symptoms in premature babies. In the study, in addition to obtaining evidence-based data on cranial osteopathic applications, it was aimed to examine the effects on the sensory profile, sleep quality, colic symptoms and motor performance of preterm babies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteopathy intervention group | Experimental | Other: Osteopathic intervention, Other: Home based exercise educationBeginning of the project assesment will be made, home exercises are going to be explained and said to continue exercises every day. Cases in this group will take 6 osteopathy sessions weekly. After 6 weeks assesment will be made again. |
| Home based exercises group | Active comparator | Other: Home based exercise educationBeginning of the project assesment will be made, home exercises are going to be explained and said to continue exercises every day. After 6 weeks assesment will be made again. |
Who may qualify
- Ages
- 1 week to 6 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Premature birth (<37 weeks)
- Corrected age <6 weeks.
- Discharged to home
- Stable condition
- Family agrees to continue home program
Key exclusion criteria (7 listed)
- Having a congenital cyanotic heart problem,
- Being born earlier than 28 weeks,
- The family not accepting to participate in the study,
- Neglecting check-ups and sessions,
- Using a respiratory appliance,
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 |
|---|---|---|
| Osteopathic interventionResearcher will use osteopathic techniques on cranial area includes light touch. Home based exercises will be show on cases and demand to do exercise regularly | Other | Osteopathy intervention group |
| Home based exercise educationHome based exercises will be show on cases and demand to do exercise regularly. | Other | Home based exercises group, Osteopathy intervention group |
Primary outcome
Test of Infant Motor Performance
Time frame: 6 weeks
The test is a motor outcome measure designed to assess posture and selective control of movement in infants for functional performance in daily life. The test consists of 31 items in standard format, 28 of which are made by observing spontaneous activities and scoring them as pass or fail. Getting higher points means better motor control.
3 secondary outcomes
Assessment of General Movements
Time frame: 6 weeks
The Infant Colic Scale
Time frame: 6 weeks
Brief Infant Sleep Questionnaire
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic intervention and Home based exercise education in people with Osteopathy and PreTerm Neonate, run by Abant Izzet Baysal 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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 13 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eylem Tütün Yümin, Professor (00905056763191, tutun_e@ibu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test of Infant Motor Performance (time frame: 6 weeks). 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 13 May 2025.