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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
Van Regional Training and Research Hospital
Van, Turkey, Turkey (Türkiye)
RECRUITINGSleep Quality of Preterm Infants
Sleep duration and awakenings assessed using actigraphy and researcher observation before and after massage sessions.
Time frame: Measured daily over 3 days of massage intervention
Infant Comfort Level
Measured using Premature Infant Comfort Scale , higher scores indicate lower comfort.
Time frame: Assessed before first massage and after last massage session (Day 3)
Infant Stress Levels
Measured using Neonatal Stress Scale; higher scores indicate greater stress.
Time frame: Assessed before first massage and after last massage session (Day 3)
Heart Rate of Preterm Infants During Massage Therapy
Heart rate will be measured using a bedside monitor as an indicator of physiological response to massage therapy. Unit of measure: beats per minute (bpm).
Time frame: Baseline (prior to the first massage session) and immediately after each massage session over 3 days
Respiratory Rate of Preterm Infants During Massage Therapy
Respiratory rate will be measured using a bedside monitor as an indicator of physiological response to massage therapy. The outcome will be expressed as breaths per minute.
Time frame: Baseline (prior to the first massage session) and immediately after each massage session over 3 days
Oxygen Saturation of Preterm Infants During Massage Therapy
Oxygen saturation will be measured noninvasively using pulse oximetry to assess physiological response to massage therapy. The outcome will be expressed as percentage (%).
Time frame: Baseline (prior to the first massage session) and immediately after each massage session over 3 days
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