Infant Massage for Lymphedema and Comfort in Preterm Newborns
The Effectiveness of Infant Massage in Reducing Immobilization-Related Lymphedema Symptoms and Increasing Comfort in Preterm Newborns
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Birgül Tuncay, PhD
- Phone Number: 05337615764
- Email: birgul.tuncay@erzurum.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Infant Massage Group
The massage application consists of gentle tactile stimulation targeting the extremities and lymphatic drainage pathways.
The therapy is performed for 15 minutes once daily for 14 days by a trained researcher/nurse.
The technique is adapted for preterm physiology to ensure safety and comfort.
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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.
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|
No Intervention: Control Group
Routine clinical management provided to preterm infants in the NICU, including standard medical treatment, feeding, positioning, and hygiene care according to the unit's protocols.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Extremity Circumference
Time Frame: 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.
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Baseline (Day 0), Day 7, and Day 14
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Change in Pitting Edema Grade
Time Frame: 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.
|
Baseline (Day 0), Day 7, and Day 14
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Comfort Level (Premature Infant Comfort Scale)
Time Frame: 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).
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Baseline (Day 0), Day 7, and Day 14 (Assessed before and after the intervention)
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Change in Heart Rate
Time Frame: Baseline (Day 0), Day 7, and Day 14 (Measured before, during, and after intervention)
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Heart rate is monitored to evaluate the infant's physiological response to the massage.
It is measured in beats per minute (bpm).
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Baseline (Day 0), Day 7, and Day 14 (Measured before, during, and after intervention)
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Change in Oxygen Saturation
Time Frame: Baseline (Day 0), Day 7, and Day 14 (Measured before, during, and after intervention)
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Oxygen saturation levels are monitored to assess respiratory stability and physiological comfort.
It is measured as a percentage (SpO2 %).
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Baseline (Day 0), Day 7, and Day 14 (Measured before, during, and after intervention)
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Change in Body Temperature
Time Frame: Baseline (Day 0), Day 7, and Day 14 (Measured before, during, and after intervention)
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Body temperature is recorded to monitor thermoregulation during the massage application.
It is measured in degrees Celsius (°C).
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Baseline (Day 0), Day 7, and Day 14 (Measured before, during, and after intervention)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ayşe Gürol, PhD, Erzurum Technical University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- birgul05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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