The Effect of Cranial Osteopathy Intervention in Preterm Babies

NCT ID: NCT06967870

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-05
• Study Completion Date: 2025-10-08

Brief 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. 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.

Conditions

Osteopathy; PreTerm Neonate; Sensory Profiles; Colic; Sleep Quality; Motor Development of Premature Infants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Osteopathy intervention group

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.

Group Type: EXPERIMENTAL

Osteopathic intervention

Intervention Type: OTHER

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 education

Intervention Type: OTHER

Home based exercises will be show on cases and demand to do exercise regularly.

Home based exercises group

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.

Group Type: ACTIVE_COMPARATOR

Home based exercise education

Intervention Type: OTHER

Home based exercises will be show on cases and demand to do exercise regularly.

Interventions

Osteopathic intervention

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

Intervention Type: OTHER

Home based exercise education

Home based exercises will be show on cases and demand to do exercise regularly.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Premature birth (<37 weeks)
• Corrected age <6 weeks.
• Discharged to home
• Stable condition
• Family agrees to continue home program

Exclusion Criteria

• 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

• Minimum Eligible Age: 1 Week
• Maximum Eligible Age: 6 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abant Izzet Baysal University

OTHER

Sponsor Role: lead

Responsible Party

Eylem TÜTÜN YÜMİN

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bahriye Baş

Bursa, Osmangazi, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Eylem Tütün Yümin, Professor

Role: CONTACT

tutun_e@ibu.edu.tr

00905056763191

Other Identifiers

AIBU-FTR-ETY-04

Identifier Type: -

Identifier Source: org_study_id