The Effect of Massage on Sleep Quality, Stress, Comfort, and Vital Signs in Preterm Infants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-37
SponsorYuzuncu Yil University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Infant Massage Therapy
Other interventionPreterm 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Experimental GroupExperimental treatment 1 intervention
Group B: Control - Standard CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Sleep 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 interventionSecondary outcomes
1
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)2
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)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 days4
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 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov