Massage to improve sleep, comfort, and vital signs in preterm infants
The Effect of Massage on Sleep Quality, Stress, Comfort, and Vital Signs in Preterm Infants: A Randomized Controlled Trial
This trial will see if giving medically stable preterm infants (35–37 weeks) a 15-minute massage three times a day for three days in the NICU improves sleep, reduces stress, increases comfort, and stabilizes vital signs compared with standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 35 Months to 37 Months |
| Sex | All |
| Sponsor | Yuzuncu Yil University Academic / other |
| Locations | 1 site (Van, Turkey) |
| Trial ID | NCT07322731 on ClinicalTrials.gov |
What this trial studies
This randomized controlled study enrolls preterm infants born at 35–37 weeks and admitted to the NICU at Van Regional Training and Research Hospital. Infants are randomly assigned to an intervention group that receives a standardized 15-minute massage three times daily for three consecutive days or to a control group receiving standard care. Outcomes include behavioral measures (Premature Infant Comfort Scale, Neonatal Stress Scale), objective sleep monitoring with actigraphy and timing, and physiological vital signs recorded before and after interventions. Data will be analyzed using standard statistical tests in SPSS to compare within- and between-group changes.
Who should consider this trial
Good fit: Medically stable preterm infants born at 35–37 weeks gestation who are admitted to the NICU and cleared for massage by a neonatologist with parental consent are ideal candidates.
Not a fit: Infants with major congenital anomalies, known neurological disorders, requiring mechanical ventilation or intensive respiratory support, or otherwise medically unstable are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the intervention could improve sleep and comfort and reduce stress in preterm infants, which may support recovery and development in the NICU.
How similar studies have performed: Prior smaller trials and meta-analyses of neonatal massage have reported improvements in weight gain, stress markers, and sleep in some settings, though results vary by protocol and patient population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Preterm infants born between 35-37 weeks gestational age. * Admitted to the neonatal intensive care unit (NICU). * Medically stable and cleared for massage therapy by neonatologist. * Parental/guardian consent obtained. Exclusion Criteria: * Infants with congenital anomalies or major medical complications. * Infants requiring mechanical ventilation or intensive respiratory support. * Infants with known neurological disorders. * Parental/guardian refusal or inability to participate.
Where this trial is running
Van, Turkey
- Van Regional Training and Research Hospital — Van, Turkey, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: RIDVAN AKDOĞAN, PhD
- Email: ridvanakdogan@yyu.edu.tr
- Phone: +905413980680
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.