NCT07322731 The Effect of Massage on Sleep Quality, Stress, Comfort, and Vital Signs in Preterm Infants
| NCT ID | NCT07322731 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yuzuncu Yil University |
| Condition | Premature Infants |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-08-15 |
| Primary Completion | 2026-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-08-15 with a primary completion date of 2026-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This randomized controlled trial investigates the effects of massage therapy on sleep quality, stress, comfort, and vital signs in preterm infants (gestational age 35-37 weeks) admitted to the Neonatal Intensive Care Unit (NICU) at Van YYU Training and Research Hospital. Infants in the intervention group will receive a 15-minute massage three times a day for three consecutive days, while the control group will receive standard care. Data will be collected using the Premature Infant Comfort Scale, Neonatal Stress Scale, actigraphy for sleep monitoring, and vital sign measurements. The study aims to determine whether massage therapy can improve the overall well-being and development of preterm infants in NICU settings.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07322731 clinical trial?
This trial is open to participants of all sexes, aged 35 Months or older, up to 37 Months, studying Premature Infants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07322731 currently recruiting?
Yes, NCT07322731 is actively recruiting participants. Contact the research team at ridvanakdogan@yyu.edu.tr for enrollment information.
Where is the NCT07322731 trial being conducted?
This trial is being conducted at Van, Turkey (Türkiye).
Who is sponsoring the NCT07322731 clinical trial?
NCT07322731 is sponsored by Yuzuncu Yil University. The trial plans to enroll 40 participants.