- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07388732
The Effect of Abdominal Massage on Jaundice and Defecation in Newborn Babies
Effects of Abdominal Massage Applied Once and Twice Daily in Phototherapy-Treated Term Newborns on Bilirubin Levels and Defecation: Randomized Controlled Trial
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.
This 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.
The 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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Province
-
Kütahya, Province, Turkey (Türkiye), 43000
- Kütahya Health Sciences University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Term newborns (37-42 weeks gestation)
- 2-10 days postpartum
- Diagnosed with hyperbilirubinemia
- Receiving phototherapy
- Fully orally fed.
Exclusion Criteria:
- Newborns with ABO incompatibility or Rh incompatibility.
- Diagnosed with direct hyperbilirubinemia.
- Genetic/metabolic diseases
- Infections within 24 hours
- With a need for fluid replacement
- Having skin anomalies
- Having abdominal disorders and surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
|
|
|
Experimental: Massage-1 Group
Babies in Massage-1 received a 10-minute abdominal massage once a day before feeding for three days.
|
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.
|
|
Experimental: Massage-2 Group
Babies in the Massage-2 group received a 10-minute abdominal massage twice a day before feeding for three days.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
A transcutaneous bilirubin levels
Time Frame: 6 hours after phototherapy
|
6 hours after phototherapy
|
|
Defecation
Time Frame: Diapers were changed a total of 8 times a day. Defecation outcome was assessed in 24-hour intervals for 3 days.
|
Diapers were changed a total of 8 times a day. Defecation outcome was assessed in 24-hour intervals for 3 days.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019/137
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Phototherapy
-
University of Nove de JulhoUniversity of Bergen; Fundação de Amparo à Pesquisa do Estado de São PauloCompleted
-
Medical University of ViennaCompleted
-
Groupe Hospitalier Paris Saint JosephCompletedNeonatal PhototherapyFrance
-
Paulista UniversityCompletedTraining | Phototherapy | Autonomic Nervous SystemBrazil
-
University of Nove de JulhoFundação de Amparo à Pesquisa do Estado de São PauloCompletedPhototherapy | Systemic | Low-level Laser TherapyBrazil
-
Children's Hospital Medical Center, CincinnatiRecruiting
-
University of Nove de JulhoFundação de Amparo à Pesquisa do Estado de São PauloCompletedMuscle Development in Association to PhototherapyBrazil
-
Universidade Norte do ParanáNot yet recruitingExercise | Phototherapy | Muscle Recovery | Futsal
-
Universidade Norte do ParanáNot yet recruitingExercise | Phototherapy | Muscle Performance | Futsal
-
Charite University, Berlin, GermanyTechnische Universität BerlinActive, not recruiting
Clinical Trials on Massage once a day for 3 days.
-
Galapagos NVCompleted
-
Sun Yat-sen UniversityWest China Hospital; First Affiliated Hospital Xi'an Jiaotong UniversityRecruitingTriple-Negative Breast Cancer (TNBC)China
-
Hyundai PharmCompletedContraceptionKorea, Republic of
-
University Hospital Southampton NHS Foundation...NIHR Southampton Respiratory Biomedical Research Centre; Asthma, Allergy and...Not yet recruitingIdiopathic Pulmonary Fibrosis | Interstitial Lung Disease
-
Marmara UniversityNot yet recruiting
-
Biokosmes SrlRecruitingDermatitis | Dermatitis, Contact | Dermatitis, Eczematous | Dermatitis, Chronic | Dermatitis, Atopic DermatitisItaly
-
The University of Texas Health Science Center,...CompletedHuman Papilloma Virus | Dysplasia | CIN1 | CIN2United States
-
Federal Budgetary Research Institution State Research...CompletedSmallpox | Monkeypox | Cowpox | Vaccinia Virus InfectionRussian Federation
-
PHARMENTERPRISES LLCNot yet recruitingSARS-CoV-2 Infection | Lung Fibrosis
-
LEO PharmaCompleted