NCT07322731

The Effect of Massage on Sleep Quality, Stress, 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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Yuzuncu Yil University · Academic / Other
• Sex: All
• Age: 35 Months – 37 Months
• Healthy volunteers: Not accepted

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.

Detailed description

This randomized controlled study evaluates the impact of massage therapy on preterm infants' sleep quality, stress levels, comfort, and vital signs in the Neonatal Intensive Care Unit (NICU) at Van YYU Training and Research Hospital. Infants born between 35 and 37 weeks of gestation and meeting inclusion criteria will be randomly assigned to either an intervention group receiving massage or a control group receiving standard care. The intervention consists of a 15-minute massage administered three times daily for three consecutive days by a trained researcher. Massage includes gentle stroking and circular movements of the legs, arms, back, and hands, following a standardized protocol. Physiological parameters (heart rate, respiratory rate, blood pressure, oxygen saturation), sleep patterns (using actigraphy and chronometer), and behavioral assessments using the Premature Infant Comfort Scale and Neonatal Stress Scale will be recorded before and after the intervention. Data will be analyzed using SPSS version 25. Group homogeneity will be assessed with chi-square or Fisher's exact tests, within-group comparisons with paired t-tests, and between-group comparisons with independent t-tests. Significance will be set at p \< 0.05. This study aims to provide evidence on the efficacy of massage therapy as a non-pharmacological intervention to improve preterm infants' comfort, reduce stress, and enhance sleep quality in NICU settings.

Conditions

• Premature Infants
• Sleep Quality
• İnfant Stress
• İnfant Comfort
• Vital Signs
• NICU

Interventions

Type	Name	Description
OTHER	Infant Massage Therapy	Preterm infants receive a standardized massage therapy protocol three times daily for 15 minutes over 3 days. The massage is applied by a trained nurse and includes legs, arms, and back following a structured sequence.

Timeline

• Start date: 2025-08-15
• Primary completion: 2026-05-15
• Completion: 2026-06-15
• First posted: 2026-01-07
• Last updated: 2026-01-07

Locations

1 site across 1 country: Turkey (Türkiye)