Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:13 AM
Study NCT ID:
NCT07388732
Status:
COMPLETED
Last Update Posted:
2026-02-05
First Post:
2026-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Abdominal Massage on Jaundice and Defecation in Newborn Babies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007567', 'term': 'Jaundice, Neonatal'}, {'id': 'D007565', 'term': 'Jaundice'}, {'id': 'D006932', 'term': 'Hyperbilirubinemia'}], 'ancestors': [{'id': 'D051556', 'term': 'Hyperbilirubinemia, Neonatal'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Newborns meeting the sampling criteria were assigned to experimental and control groups using a simple random number table. The study was single-blind because the researchers knew which group the newborns in the sample were in. However, the statistical analysis was double-blind because the statistics for the data were performed by a different person.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-04', 'studyFirstSubmitDate': '2026-01-28', 'studyFirstSubmitQcDate': '2026-02-04', 'lastUpdatePostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A transcutaneous bilirubin levels', 'timeFrame': '6 hours after phototherapy'}, {'measure': 'Defecation', 'timeFrame': 'Diapers were changed a total of 8 times a day. Defecation outcome was assessed in 24-hour intervals for 3 days.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Infant massage', 'Newborn', 'Phototherapy', 'Jaundice', 'Hyperbilirubinemia', 'Bilirubin'], 'conditions': ['Hyper Bilirubinemia', 'Phototherapy', 'Jaundice, Neonatal']}, 'descriptionModule': {'briefSummary': 'Hyperbilirubinemia is a common condition in term newborns and is often treated with phototherapy. It is thought that abdominal massage may increase bowel movements, thereby increasing the frequency of defecation and supporting bilirubin excretion.\n\nThis randomized controlled trial aimed to evaluate the effect of abdominal massage, applied once or twice daily using the Vimala technique, on transcutaneous bilirubin levels and defecation frequency in hyperbilirubinemia-affected term newborns receiving phototherapy in the neonatal intensive care unit.\n\nThe study was conducted in the neonatal intensive care unit of a university hospital between February 29, 2020, and August 17, 2023. A total of 35 newborns meeting the inclusion criteria were randomly divided into three groups. Group Massage-1 received 10 minutes of abdominal massage once daily before feeding for three days (n=12). Group Massage-2 received massage twice daily for the same duration (n=10). The control group received routine care (n=13).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Days', 'minimumAge': '2 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Term newborns (37-42 weeks gestation)\n* 2-10 days postpartum\n* Diagnosed with hyperbilirubinemia\n* Receiving phototherapy\n* Fully orally fed.\n\nExclusion Criteria:\n\n* Newborns with ABO incompatibility or Rh incompatibility.\n* Diagnosed with direct hyperbilirubinemia.\n* Genetic/metabolic diseases\n* Infections within 24 hours\n* With a need for fluid replacement\n* Having skin anomalies\n* Having abdominal disorders and surgery.'}, 'identificationModule': {'nctId': 'NCT07388732', 'briefTitle': 'The Effect of Abdominal Massage on Jaundice and Defecation in Newborn Babies', 'organization': {'class': 'OTHER', 'fullName': 'Kutahya Health Sciences University'}, 'officialTitle': 'Effects of Abdominal Massage Applied Once and Twice Daily in Phototherapy-Treated Term Newborns on Bilirubin Levels and Defecation: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2019/137'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Massage-1 Group', 'description': 'Babies in Massage-1 received a 10-minute abdominal massage once a day before feeding for three days.', 'interventionNames': ['Other: Massage once a day for 3 days.']}, {'type': 'EXPERIMENTAL', 'label': 'Massage-2 Group', 'description': 'Babies in the Massage-2 group received a 10-minute abdominal massage twice a day before feeding for three days.', 'interventionNames': ['Other: Massage twice a day for 3 days.']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group'}], 'interventions': [{'name': 'Massage once a day for 3 days.', 'type': 'OTHER', 'description': "The Vimala Massage Application, before massaging, hands were washed and lubricated. The massage began with a patting motion on the newborn's abdomen, followed by clockwise circular movements and semicircles. The massage was then performed in the shapes of an I, inverted L, and U along the abdomen. Finally, a walking movement was performed with the fingertips from the right to the left side of the abdomen. Each movement was repeated six times.", 'armGroupLabels': ['Massage-1 Group']}, {'name': 'Massage twice a day for 3 days.', 'type': 'OTHER', 'description': "The Vimala Massage Application, before massaging, hands were washed and lubricated. The massage began with a patting motion on the newborn's abdomen, followed by clockwise circular movements and semicircles. The massage was then performed in the shapes of an I, inverted L, and U along the abdomen. Finally, a walking movement was performed with the fingertips from the right to the left side of the abdomen. Each movement was repeated six times.", 'armGroupLabels': ['Massage-2 Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43000', 'city': 'Kütahya', 'state': 'Province', 'country': 'Turkey (Türkiye)', 'facility': 'Kütahya Health Sciences University', 'geoPoint': {'lat': 39.42417, 'lon': 29.98333}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kutahya Health Sciences University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}