Infant Massage for Lymphedema and Comfort in Preterm Newborns
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age28-37
SponsorErzurum Technical University
About this trial
This randomized controlled trial investigates the effectiveness of infant massage in reducing symptoms of immobilization-related lymphedema and improving comfort in preterm newborns hospitalized in the Neonatal Intensive Care Unit (NICU). Preterm infants frequently develop lymphedema due to their immature circulatory systems and prolonged lack of movement.
The study compares two groups of infants: one receiving standard care and another receiving a daily 15-minute massage therapy session for 14 consecutive days in addition to standard care. Researchers will evaluate the impact of the massage by measuring the circumference of the infants' wrists, elbows, ankles, and knees to assess fluid reduction. Additionally, the infants' comfort levels will be assessed using the Premature Infant Comfort Scale (PICS). The goal is to determine if massage can serve as a safe, non-invasive method to manage lymphedema and reduce distress in this vulnerable population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis of lymphedema.
Hemodynamic and clinical stability.
No current or recent (within 24 hours) administration of analgesic or sedative medications that could mask comfort assessments.
Intact skin integrity with no contraindications for topical massage.
Disqualifiers
Major congenital anomalies.
Severe respiratory, cardiac, or neurological instability during the study period.
Any acute medical contraindication identified by the attending neonatologist.
Trial design
Design model
Parallel
Treatments tested in this trial
Infant Massage Group
BehavioralThe intervention involves a standardized infant massage therapy protocol applied by a trained researcher. The massage consists of gentle tactile stimulation targeting the upper and lower extremities to facilitate lymphatic drainage. The sessions are conducted for 15 minutes, once daily, for a period of 14 consecutive days. This intervention is provided in addition to standard NICU care.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Infant Massage GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in Extremity Circumference
Circumference measurements of the upper and lower extremities (specifically the wrist, elbow, ankle, and knee) will be taken using a non-elastic tape measure. Measurements are recorded in centimeters to assess the reduction of fluid accumulation. A decrease in circumference indicates improvement in lymphedema symptoms.
Time frame
Baseline (Day 0), Day 7, and Day 142
Change in Pitting Edema Grade
Pitting edema severity is assessed by applying gentle pressure to the edematous area for 5 seconds and observing the depth and duration of the indentation (pitting). It is graded on a standard clinical scale (e.g., +1 to +4), where higher scores indicate more severe edema and lower scores indicate improvement.
Time frame
Baseline (Day 0), Day 7, and Day 14Secondary outcomes
1
Change in Comfort Level (Premature Infant Comfort Scale)
Neonatal comfort is assessed using the Premature Infant Comfort Scale. The scale consists of 7 items, each scored from 1 to 5. The total score ranges from 7 to 35. A score of 35 indicates the lowest level of comfort (highest distress), while a score of 7 indicates the highest level of comfort. Higher scores indicate lower comfort levels (worse outcome).
Time frame
Baseline (Day 0), Day 7, and Day 14 (Assessed before and after the intervention)2
Change in Heart Rate
Heart rate is monitored to evaluate the infant's physiological response to the massage. It is measured in beats per minute (bpm).
Time frame
Baseline (Day 0), Day 7, and Day 14 (Measured before, during, and after intervention)3
Change in Oxygen Saturation
Oxygen saturation levels are monitored to assess respiratory stability and physiological comfort. It is measured as a percentage (SpO2 %).
Time frame
Baseline (Day 0), Day 7, and Day 14 (Measured before, during, and after intervention)4
Change in Body Temperature
Body temperature is recorded to monitor thermoregulation during the massage application. It is measured in degrees Celsius (°C).
Time frame
Baseline (Day 0), Day 7, and Day 14 (Measured before, during, and after intervention)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: