The Effect of Massage on Sleep Quality, Stress, Comfort, and Vital Signs in Preterm Infants: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Sleep Quality of Preterm Infants
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
No masking; open-label study.
Eligibility Criteria
- Ages
- 35 Months to 37 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Sleep Quality of Preterm Infants
Time Frame: Measured daily over 3 days of massage intervention
Sleep duration and awakenings assessed using actigraphy and researcher observation before and after massage sessions.
Secondary Outcomes
- Infant Comfort Level(Assessed before first massage and after last massage session (Day 3))
- Infant Stress Levels(Assessed before first massage and after last massage session (Day 3))
- Heart Rate of Preterm Infants During Massage Therapy(Baseline (prior to the first massage session) and immediately after each massage session over 3 days)
- Respiratory Rate of Preterm Infants During Massage Therapy(Baseline (prior to the first massage session) and immediately after each massage session over 3 days)
- Oxygen Saturation of Preterm Infants During Massage Therapy(Baseline (prior to the first massage session) and immediately after each massage session over 3 days)
Investigators
Rıdvan Akdogan
Assistant Professor
Yuzuncu Yil University