| CTRI Number |
CTRI/2025/09/095422 [Registered on: 26/09/2025] Trial Registered Prospectively |
| Last Modified On: |
26/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [ EFFECTIVENESS OF ORIGAMI ON ANXIETY ] |
| Study Design |
Other |
|
Public Title of Study
|
Coconut Oil Massage Therapy on Bilirubin Levels, Growth, and Vital Stability among Neonates who are Undergoing Phototherapy. |
|
Scientific Title of Study
|
Effectiveness of Coconut Oil Massage Therapy on Bilirubin Levels, Growth, and Vital Stability among Neonates who are Undergoing Phototherapy: A Randomised Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nongmeikapam Helena |
| Designation |
Assistant Professor |
| Affiliation |
Sharda University |
| Address |
Faculty Room, 2nd floor, SSNSR Block 4.
Knowledge Park III, Plot 32, Gautam Buddha Nagar
Greater Noida, Uttar Pradesh 201306
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9731784267 |
| Fax |
|
| Email |
helena.nongmeikapam@sharda.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Nongmeikapam Helena |
| Designation |
Assistant Professor |
| Affiliation |
Sharda University |
| Address |
Faculty Room, 2nd floor, SSNSR Block 4.
Knowledge Park III, Plot 32, Gautam Buddha Nagar
Greater Noida, Uttar Pradesh 201306
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9731784267 |
| Fax |
|
| Email |
helena.nongmeikapam@sharda.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Nongmeikapam Helena |
| Designation |
Assistant Professor |
| Affiliation |
Sharda University |
| Address |
Faculty Room, 2nd floor, SSNSR Block 4.
Knowledge Park III, Plot 32, Gautam Buddha Nagar
Greater Noida, Uttar Pradesh 201306
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9731784267 |
| Fax |
|
| Email |
helena.nongmeikapam@sharda.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nongmeikapam Helena |
| Address |
2nd Floor Faculty Room, SSNSR Department, Block 4. Knowledge Park III Sharda University Greater Noida. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajeev Thapar |
Sharda Hospitl |
2nd Floor/ Department of Paediatrics, NICU/ 201
Gautam Buddha Nagar
UTTAR PRADESH |
983944828
rajeev.thapar@sharda.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Sharda UniversityECR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P599||Neonatal jaundice, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Coconut Oil |
FREQUENCY & DURATION:
3 sessions per day, each lasting 10–15 minutes.
Total duration: 5 days or until bilirubin levels normalise.
Each step is designed to be non-invasive, soothing, and developmentally supportive.
The sequence and timing of massage are based on research-supported approaches for neonatal care and are aligned with guidelines for complementary therapy in neonates.
Regular, gentle massage may also improve weight gain,feeding efficiency, and overall neurobehavioral outcomes in preterm and term infants.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
2.00 Day(s) |
| Age To |
7.00 Day(s) |
| Gender |
Both |
| Details |
Neonates aged 2 to 7 days
Diagnosed with physiological hyperbilirubinemia
Serum total bilirubin levels within phototherapy threshold, but below exchange transfusion threshold, based on AAP or IAP nomograms.
STB between 12 to 17 mg per dL
Gestational age above 37 weeks
Birth weight less than 1800 grams
Stable clinical condition
Parent or guardian Assent
|
|
| ExclusionCriteria |
| Details |
Preterm infants
Neonates with congenital anomalies or major structural malformations
Direct (conjugated) hyperbilirubinemia: Direct bilirubin less than 20 percent of total or less than 2 mg per dL
Serum bilirubin exceeding the exchange transfusion threshold
Neonates requiring exchange transfusion
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Massage therapy will result in a significant reduction in bilirubin levels and growth promotion.
More effective massage therapy will be developed against the existing phototherapy protocol.
The findings could support the inclusion of massage as a complementary therapy in neonatal jaundice management protocols.
|
1 week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Neonatal jaundice, caused by hyperbilirubinemia, is one of the most common conditions in newborns. Although phototherapy is the standard treatment, it may be associated with complications such as dehydration, electrolyte imbalance, and disruption of maternal–infant bonding. Complementary therapies such as massage may offer additional benefits by enhancing bilirubin elimination, promoting growth, and stabilizing vital functions. This randomised controlled trial will evaluate the effectiveness of neonatal oil massage therapy in term neonates undergoing phototherapy at Sharda Hospital, Greater Noida. A total of 160 neonates diagnosed with physiological hyperbilirubinemia will be randomly assigned to either the intervention group (phototherapy plus oil massage) or the control group (phototherapy alone). The intervention involves standardized oil massage using warmed coconut oil for 10–15 minutes, three times daily, over a period of five days or until bilirubin normalization. Primary outcome measures include changes in serum bilirubin levels, assessed at baseline and 24-hour intervals. Secondary outcomes include weight gain and vital stability parameters (heart rate, respiratory rate, temperature, and oxygen saturation), monitored throughout the intervention. Data will be analyzed using independent t-tests, repeated measures ANOVA, and chi-square tests, with significance set at p < 0.05. It is anticipated that neonates receiving oil massage will demonstrate faster bilirubin reduction, improved growth, and greater physiological stability compared to those receiving phototherapy alone. Findings may provide evidence for integrating neonatal massage as a cost-effective, non-invasive complementary therapy in the management of neonatal jaundice. The trial contains both the pilot and main study. |