Infant Massage for Lymphedema and Comfort in Preterm Newborns

NCT07418814 | Not Yet Recruiting

• 1 other identifier: birgul05
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lymphedema; Premature Birth; Edema; Immobilization

Keywords

Infant Massage; Preterm Infant; Lymphedema; Neonatal Comfort; Massage Therapy; Immobilization

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline (Day 0), Day 7, and Day 14

• 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.

  Baseline (Day 0), Day 7, and Day 14

Secondary Outcomes (4)

• Change in Comfort Level (Premature Infant Comfort Scale)

  Baseline (Day 0), Day 7, and Day 14 (Assessed before and after the intervention)

• Change in Heart Rate

  Baseline (Day 0), Day 7, and Day 14 (Measured before, during, and after intervention)

• Change in Oxygen Saturation

  Baseline (Day 0), Day 7, and Day 14 (Measured before, during, and after intervention)

• Change in Body Temperature

  Baseline (Day 0), Day 7, and Day 14 (Measured before, during, and after intervention)

Study Arms (2)

Infant Massage Group

EXPERIMENTAL

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.

Behavioral: Infant Massage Group

Control Group

NO INTERVENTION

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.

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.

Infant Massage Group

Eligibility Criteria

• Age: 28 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erzurum Technical University: lead

MeSH Terms

Conditions

Lymphedema; Premature Birth; Edema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ayşe Gürol, PhD

  Erzurum Technical University

  STUDY DIRECTOR

Central Study Contacts

Birgül Tuncay, PhD

CONTACT

05337615764; birgul.tuncay@erzurum.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 18, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share