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The Effect of Massage on Sleep Quality, Stress, Comfort, and Vital Signs in Preterm Infants: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 3
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Turkey
Van Regional Training and Research Hospital
RECRUITING
Van
Contact Information
Primary
RIDVAN AKDOĞAN, PhD
ridvanakdogan@yyu.edu.tr
+905413980680
Backup
YUSUF GÜRGAN, Msc Student
yusufgurgan95@gmail.com
+905442941180
Time Frame
Start Date: 2025-08-15
Estimated Completion Date: 2026-06-15
Participants
Target number of participants: 40
Treatments
Experimental: Experimental Group
Preterm infants receiving massage therapy three times daily for 15 minutes over 3 days, in addition to standard care.
No_intervention: Control - Standard Care
Preterm infants receiving standard care only, without massage intervention.
Related Therapeutic Areas
Sponsors
Leads: Yuzuncu Yil University

This content was sourced from clinicaltrials.gov