Massage to improve sleep, comfort, and vital signs in preterm infants
Official title: The Effect of Massage on Sleep Quality, Stress, Comfort, and Vital Signs in Preterm Infants: A Randomized Controlled Trial
Run by Yuzuncu Yil University · NCT07322731 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 35 Months to 37 Months |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Yuzuncu Yil University Academic / other |
| Locations | 1 site (Van, Turkey) |
| Status | Recruiting |
| Started | August 15, 2025 |
| Main results expected | May 15, 2026 |
| Study ends | June 15, 2026 |
| Registry record updated | January 7, 2026 |
| Trial ID | NCT07322731 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.