Actively Recruiting
The Effect of Massage on Sleep Quality, Stress, Comfort, and Vital Signs in Preterm Infants: A Randomized Controlled Trial
Led by Yuzuncu Yil University · Updated on 2026-01-07
40
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of massage therapy on sleep quality, stress, comfort, and vital signs in preterm infants born between 35 and 37 weeks gestational age who are admitted to the Neonatal Intensive Care Unit (NICU) at Van YYU Training and Research Hospital. This randomized controlled trial aims to determine whether massage therapy can improve the overall well-being and development of these infants during their NICU stay. Infants in the intervention group will receive a 15-minute massage three times a day for three consecutive days, administered by a trained nurse following a standardized protocol that includes gentle stroking and circular movements of the legs, arms, back, and hands. The control group will receive standard care without massage. Physiological parameters such as heart rate, respiratory rate, blood pressure, and oxygen saturation will be monitored, along with sleep patterns using actigraphy and chronometer, and behavioral assessments using the Premature Infant Comfort Scale and Neonatal Stress Scale. Participants will be evaluated before and after the massage sessions over the three-day period. Data collection includes daily measurements of sleep quality, stress levels, comfort, and vital signs immediately before and after massage sessions. The research team will analyze these results to assess the impact of massage therapy on infant health and comfort in the NICU environment. The total participation period is three days during the intervention phase.
CONDITIONS
Brief Title
The Effect of Massage on Sleep Quality, Stress, Comfort, and Vital Signs in Preterm Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or guardian consent obtained
You will not qualify if you...
- Infants with congenital anomalies or major medical complications
- Infants requiring mechanical ventilation or intensive respiratory support
- Infants with known neurological disorders
- Parental or guardian refusal or inability to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants receive a standardized massage therapy three times daily for 15 minutes over 3 consecutive days, or receive standard care without massage. Physiological parameters, sleep patterns, and behavioral assessments are recorded before and after the intervention.
Daily visits for 3 days
Trial Site Locations
Total: 1 location
1
Van Regional Training and Research Hospital
Van, Turkey, Turkey (Türkiye), 65090
Actively Recruiting
Research Team
R
RIDVAN AKDOĞAN, PhD
Y
YUSUF GÜRGAN, Msc Student
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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