LymphedemaNCT07418814
Infant Massage for Lymphedema and Comfort in Preterm Newborns
A study testing Infant Massage Group in people with Lymphedema and Premature Birth, run by Erzurum Technical University.
Trial 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). Read more about this study
- Who is it for?
- Ages 28 to 37 weeks
- Conditions the study is for
- Lymphedema, Premature Birth, Edema
- What is being tested?
- Infant Massage Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
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- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lymphedema, Premature Birth, Edema, Immobilization
- Being tested
- Infant Massage Group
- Keywords
- Infant Massage, Preterm Infant, Lymphedema, Neonatal Comfort, Massage Therapy, Immobilization
- Medical subject headings
- Lymphedema, Premature Birth, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant Massage GroupBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (Day 0), Day 7, and Day 14
Secondary outcomes (4)
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).
Measured: Baseline (Day 0), Day 7, and Day 14 (Assessed before and after the intervention)
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).
Measured: Baseline (Day 0), Day 7, and Day 14 (Measured before, during, and after intervention)
Change in Oxygen Saturation
Oxygen saturation levels are monitored to assess respiratory stability and physiological comfort. It is measured as a percentage (SpO2 %).
Measured: Baseline (Day 0), Day 7, and Day 14 (Measured before, during, and after intervention)
Change in Body Temperature
Body temperature is recorded to monitor thermoregulation during the massage application. It is measured in degrees Celsius (°C).
Measured: Baseline (Day 0), Day 7, and Day 14 (Measured before, during, and after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzurum Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Birgül Tuncay, Erzurum Technical University
- Investigators
- Ayşe Gürol, PhD, Study director, Erzurum Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418814
- Sponsor's protocol ID
- birgul05
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy laws and ethical restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Infant Massage in Reducing Immobilization-Related Lymphedema Symptoms and Increasing Comfort in Preterm Newborns
- ClinicalTrials.gov ID
- NCT07418814
- Acronym / sponsor ID
- birgul05
- Conditions
- Lymphedema, Premature Birth, Edema, Immobilization
- Keywords
- Infant Massage, Preterm Infant, Lymphedema, Neonatal Comfort, Massage Therapy, Immobilization
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Erzurum Technical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infant Massage Group | Experimental | Behavioral: Infant Massage GroupThe 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. |
| 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. |
Who may qualify
- Ages
- 28 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (4 listed)
- Major congenital anomalies.
- Severe respiratory, cardiac, or neurological instability during the study period.
- Any acute medical contraindication identified by the attending neonatologist.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infant Massage GroupThe 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. | Behavioural | Infant Massage Group |
Primary outcome
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.
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.
4 secondary outcomes
Change in Comfort Level (Premature Infant Comfort Scale)
Time frame: Baseline (Day 0), Day 7, and Day 14 (Assessed before and after the intervention)
Change in Heart Rate
Time frame: Baseline (Day 0), Day 7, and Day 14 (Measured before, during, and after intervention)
Change in Oxygen Saturation
Time frame: Baseline (Day 0), Day 7, and Day 14 (Measured before, during, and after intervention)
Change in Body Temperature
Time frame: Baseline (Day 0), Day 7, and Day 14 (Measured before, during, and after intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy laws and ethical restrictions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ayşe Gürol, PhD study director
Erzurum Technical University
Questions about this trial
What is this clinical trial studying?
A study testing Infant Massage Group in people with Lymphedema and Premature Birth, run by Erzurum Technical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Birgül Tuncay, PhD (05337615764, birgul.tuncay@erzurum.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Extremity Circumference (time frame: Baseline (Day 0), Day 7, and Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.