Abdominal Massage for Newborn Jaundice

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2026
Neonatal jaundice is a common condition during the early postnatal period and isassociated with immature bilirubin metabolism, increased red blood cell breakdown,limited hepatic conjugation and excretion, and increased enterohepatic circulation.Although most cases are physiologic, markedly elevated bilirubin levels may lead toserious neurologic complications if not identified and treated promptly. Standard newborncare therefore includes jaundice assessment, feeding support, bilirubin monitoring, andphototherapy when clinically indicated.Abdominal massage is a non‐pharmacological and non‐invasive nursing intervention that maystimulate intestinal motility, increase stool passage, promote meconium excretion, andreduce intestinal reabsorption of bilirubin. Previous studies have suggested that infantmassage may lower bilirubin levels and increase stool frequency; however, evidence fromstandardized clinical protocols in healthy full‐term newborns remains limited. This studywill evaluate the effectiveness, feasibility, and safety of a standardized abdominalmassage intervention for neonatal jaundice.This study is a two‐arm, parallel‐group randomized controlled trial. A total of 84eligible full‐term newborns will be randomly assigned in a 1:1 ratio to either anintervention group or a control group. Block randomization with a fixed block size offour will be used to maintain balanced enrollment between groups. Allocation concealmentwill be maintained using sequentially numbered, opaque, sealed envelopes prepared by aresearcher who is not involved in participant recruitment, intervention delivery, oroutcome measurement.Because the abdominal massage procedure is readily identifiable, the nurses providing theintervention cannot be blinded. However, the nurses responsible for bilirubin measurementand data collection will not participate in randomization or massage delivery and willremain unaware of group assignment. Data analysis will also be conducted using codedgroup labels until the primary statistical analyses have been completed.Both groups will receive the same routine newborn care, including feeding support,clinical observation for jaundice, transcutaneous or serum bilirubin assessment,phototherapy when medically indicated, and discharge education. The control group willnot receive abdominal massage during the study period.Newborns assigned to the intervention group will receive routine care plus standardizedabdominal massage. The massage will be administered twice daily for 10 to 15 minutesduring hospitalization for 2 to 5 days. It will begin after medical assessment confirmsthat the newborn is clinically stable and at least 1 hour after feeding. The newborn mustbe awake and calm before the intervention begins.The standardized massage procedure includes gentle clockwise circular massage over theabdomen following the direction of intestinal movement, gentle flexion of the kneestoward the abdomen, and light circular massage across the lower abdomen and groin areafrom right to left. Excessive pressure over the liver, spleen, or unhealed umbilical areawill be avoided. The procedure will be performed by trained nurses who have completedinfant massage education and standardized intervention training. Each session will bedocumented to monitor intervention fidelity.Transcutaneous bilirubin will be measured on the forehead using a standardized bilirubinmeter at approximately 0‐6, 24, 48, 72, 96, and 120 hours after birth. If atranscutaneous bilirubin value approaches the clinical treatment threshold, total serumbilirubin will be measured according to routine clinical practice. Additional clinicaldata will include stool frequency, time to first stool passage, feeding frequency andamount, diaper frequency, daily weight change, use and duration of phototherapy, lengthof hospital stay, and adverse events. Medical records will also be reviewed forjaundice‐related outpatient visits or readmissions within 7 days after discharge.The primary analysis will evaluate differences in transcutaneous bilirubin trends overtime between the two groups. Generalized estimating equations will be used to examine theeffects of group, time, and the group‐by‐time interaction. Potential confoundingvariables, such as gestational age, birth weight, feeding method, delivery mode,percentage of weight loss, and baseline bilirubin level, may be included in adjustedanalyses when necessary. Secondary outcomes will be analyzed using appropriateparametric, nonparametric, categorical, or regression methods according to thedistribution and type of the data. All statistical tests will be two‐sided, withstatistical significance set at p < 0.05.Safety will be assessed before, during, and after each massage session. Nurses willobserve skin color, respiratory pattern, crying, abdominal distension, vomiting,activity, feeding tolerance, and vital signs. Massage will be stopped immediately if thenewborn develops persistent crying, vomiting, marked abdominal distension, skin changes,respiratory abnormalities, unstable vital signs, or any other sign of discomfort. Apediatrician will evaluate the newborn when clinically indicated. Any newborn who reachesthe threshold for phototherapy or other treatment will receive standard medical carewithout delay, regardless of group assignment.
Epistemonikos ID: 801685df410986610a22fa39bdb5267e1daa4807
First added on: Aug 06, 2026