The Effect of Massage on Sleep Quality, Stress, Comfort, and Vital Signs in Preterm Infants

Yuzuncu Yil University

Status: Enrolling

Conditions: NICU; Vital Signs; Premature Infants; Sleep Quality; İnfant Comfort; İnfant Stress

Treatments: Other: Infant Massage Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07322731

YUZUNCU_YIL_UNIVERSITY_NICU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 35 to 37 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Experimental Group

Experimental group

Description:

Preterm infants receiving massage therapy three times daily for 15 minutes over 3 days, in addition to standard care.

Treatment:

Other: Infant Massage Therapy

Control - Standard Care

No Intervention group

Description:

Preterm infants receiving standard care only, without massage intervention.