| CTRI Number |
CTRI/2022/03/041379 [Registered on: 25/03/2022] Trial Registered Prospectively |
| Last Modified On: |
24/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
effect of massage on jaundice in term newborns receiving phototherapy - a randomized controlled trial |
|
Scientific Title of Study
|
effect of massage on hyperbilirubinemia in term neonates receiving phototherapy - a randomized 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 |
suryakrishnan |
| Designation |
MSc pediatric Nursing student |
| Affiliation |
college of nursing JIPMER |
| Address |
MSc Nursing
pediatric nursing department
college of nursing
JIPMER
Puducherry
MSc pediatric nursing
pediatric nursing department
JIPMER
Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
6238277294 |
| Fax |
|
| Email |
suryakrishna199712@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR P Vetriselvi |
| Designation |
Assistant professor |
| Affiliation |
JIPMER |
| Address |
department of pediatric nursing
college of nursing
JIPMER
Pondicherry
department of pediatric nursing
college of nursing
JIPMER
Pondicherry
605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894459434 |
| Fax |
|
| Email |
vetriselvijipmer1967@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR P Vetriselvi |
| Designation |
Assistant professor |
| Affiliation |
JIPMER |
| Address |
department of pediatric nursing
college of nursing
JIPMER
Pondicherry
department of pediatric nursing
college of nursing
JIPMER
Pondicherry
605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894459434 |
| Fax |
|
| Email |
vetriselvijipmer1967@gmail.com |
|
|
Source of Monetary or Material Support
|
| intramural fund committe JIPMER, pondicherry |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
intramural commitee
JIPMER
Pondicherry |
| 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 P VETRISELVI |
JIPMER |
department of neonatology, WCH
JIPMER, Puthucherry , 605006
Pondicherry
PONDICHERRY |
9894459434
vetriselvijipmer1967@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K77||Liver disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
massage |
The term neonates will be given the massage for 15 minutes thrice a day during phototherapy. The massage will be given by the researcher in a manner that it starts from face and move towards neck and chest and then to abdomen. Next on the limbs and finally on the back. |
| Comparator Agent |
standard care( phototherapy) |
the control group receive phototherapy. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Term Neonates ( completed 37 weeks or more at birth)
Neonates admitted in NICU
APGAR score at birth 8–10
Neonates receiving phototherapy for hyperbilirubinemia of any etiology |
|
| ExclusionCriteria |
| Details |
Genetic disorders or congenital malformation.
Birth injuries including cephalhematoma.
Hemodynamically unstable neonates
On ventilator |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in bilirubin level |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| increase in defecation frequency |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
27/03/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
this study will helps to find out the effect of massage on hyperbilirubinemia in term neonates receiving phototherapy. according to this study the term neonates in experimental group will receive massage thrice in a day and the control group will receive only standard care (phototherapy) and the bilirubin level will be monitored every 24 hourly till the end o phototherapy.
|