Infant Massage for Lymphedema and Comfort in Preterm Newborns

Sponsor
Erzurum Technical University
Study ID
NCT07418814
Status
Not Yet Recruiting

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Conditions

  • Edema
  • Immobilization
  • Lymphedema
  • Premature Birth

Eligibility Criteria

Sex
ALL
Age
28 Weeks - 37 Weeks
Healthy Volunteers
Not accepted

Interventions

  • Infant Massage Group — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Feb 18, 2026
Start date
Apr 1, 2026
Status verified
Feb 2026
Primary completion
Jun 30, 2026
Completion
Apr 1, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.
  • 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.

Primary Outcome Measure

Change in Extremity Circumference [ Time Frame: Baseline (Day 0), Day 7, and Day 14 ]

Central Contacts

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