Edema, Immobilization, Lymphedema, Premature Birth
Conditions
Keywords
Infant Massage, Preterm Infant, Lymphedema, Neonatal Comfort, Massage Therapy, Immobilization
Brief summary
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.
Detailed description
Preterm infants born before the 37th week of gestation frequently encounter health challenges due to immature physiological systems, with lymphedema being a significant clinical concern precipitated by circulatory insufficiency and prolonged immobilization in the Neonatal Intensive Care Unit (NICU). This condition is characterized by abnormal fluid accumulation that, if untreated, can lead to chronic pain, infection risks, and developmental delays. While manual lymphatic drainage is the standard for adults, its application in preterm infants is limited due to skin fragility, and surgical options carry substantial risks. Consequently, there is an urgent need for non-invasive approaches to facilitate fluid movement in the absence of natural physical activity. Although infant massage is known to enhance weight gain and reduce stress, its specific efficacy in mitigating immobilization-related lymphedema through mechanical drainage has not been rigorously examined. This randomized controlled trial aims to evaluate the clinical effectiveness of infant massage as a non-invasive intervention for reducing lymphedema symptoms and enhancing comfort levels among preterm neonates. The study will be conducted at a Level III NICU, involving preterm infants hospitalized for a minimum of two weeks who meet specific eligibility criteria, including hemodynamic stability and a diagnosis of lymphedema. Participants will be randomized into an intervention group receiving standardized massage therapy and a control group receiving standard care. The intervention consists of a 15-minute daily massage regimen applied for 14 consecutive days, focusing on affected extremities and lymphatic regions using an oil-free, hypoallergenic formula. Primary outcomes, including extremity circumference measurements (wrist, elbow, ankle, knee) and pitting edema grading, will be assessed on Day 0, Day 7, and Day 14. Secondary outcomes involving neonatal comfort will be evaluated using the Premature Infant Comfort Scale (PICS). The study seeks to determine whether mechanical stimulation can effectively mitigate fluid accumulation and alleviate physiological distress in this vulnerable population.
Interventions
BEHAVIORALInfant Massage Group
The 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.
Sponsors
Erzurum Technical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
28 Weeks to 37 Weeks
Healthy volunteers
No
Inclusion criteria
To ensure a homogenous and clinically stable sample, infants meeting the following criteria will be recruited: * 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. * Absence of congenital heart disease or neurological disorders (antenatal or postnatal diagnosis). * No immediate requirement for endotracheal aspiration. * Requirement for only non-invasive respiratory support (e.g., nCPAP). * Provision of written informed consent by the legal guardians (parents).
Exclusion criteria
Infants will be excluded if they present with: * Major congenital anomalies. * Severe respiratory, cardiac, or neurological instability during the study period. * Any acute medical contraindication identified by the attending neonatologist.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Extremity Circumference | Baseline (Day 0), Day 7, and Day 14 | 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. |
| Change in Pitting Edema Grade | Baseline (Day 0), Day 7, and Day 14 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Comfort Level (Premature Infant Comfort Scale) | Baseline (Day 0), Day 7, and Day 14 (Assessed before and after the intervention) | 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). |
| Change in Heart Rate | Baseline (Day 0), Day 7, and Day 14 (Measured before, during, and after intervention) | Heart rate is monitored to evaluate the infant's physiological response to the massage. It is measured in beats per minute (bpm). |
| Change in Oxygen Saturation | Baseline (Day 0), Day 7, and Day 14 (Measured before, during, and after intervention) | Oxygen saturation levels are monitored to assess respiratory stability and physiological comfort. It is measured as a percentage (SpO2 %). |
| Change in Body Temperature | Baseline (Day 0), Day 7, and Day 14 (Measured before, during, and after intervention) | Body temperature is recorded to monitor thermoregulation during the massage application. It is measured in degrees Celsius (°C). |
Contacts
CONTACTBirgül Tuncay, PhD
STUDY_DIRECTORAyşe Gürol, PhD
Erzurum Technical University
Outcome results
None listed