| CTRI Number |
CTRI/2019/04/018817 [Registered on: 29/04/2019] Trial Registered Prospectively |
| Last Modified On: |
26/04/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [yakson therapy and kinesthetic stimulation] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy of Yakson Touch and Kinesthetic stimulation on the Behavioral development,pain and vitals of preterm neonate in a tertiary care hospital Bhubaneswar:A randomized control trial |
|
Scientific Title of Study
|
Efficacy of Yakson Touch and Kinesthetic stimulation on the Behavioral development,pain and vitals of preterm neonate in a tertiary care hospital Bhubaneswar:A randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rashmiranjita Parhi |
| Designation |
PG student |
| Affiliation |
KINS,KIIT UNIVERSITY |
| Address |
Kalinga Institute of Nursing Sciences
KIMS,Campus-5
KIIT- Deemed to be University
Bhubaneswar,Odisha
odisha
Kalinga Institute of Nursing Sciences
KIMS,Campus-5
KIIT- Deemed to be University
Bhubaneswar,Odisha
odisha
Khordha
ORISSA
751024
India |
| Phone |
9776531827 |
| Fax |
|
| Email |
parhi.rashmiranjita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Mrs Niyati Das |
| Designation |
Vice principal cum professor,Dept. of Pediatric Nursing |
| Affiliation |
KINS,KIIT UNIVERSITY |
| Address |
Kalinga Institute of Nursing Sciences
KIMS,Campus-5
KIIT-Deemed to be University
Bhubaneswar
odisha
Kalinga Institute of Nursing Sciences
KIMS,Campus-5
KIIT-Deemed to be University
Bhubaneswar
odisha
Khordha
ORISSA
751024
India |
| Phone |
9438924618 |
| Fax |
|
| Email |
das.nyati@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Rashmiranjita Parhi |
| Designation |
PG student |
| Affiliation |
KINS,KIIT UNIVERSITY |
| Address |
Campus-5
KIIT- University
Bhubaneswar
odisha
Campus-5
KIIT- University
Bhubaneswar
odisha
Khordha
ORISSA
751024
India |
| Phone |
9776531827 |
| Fax |
|
| Email |
parhi.rashmiranjita@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rashmiranjita parhi |
| Address |
Campus-5
Kiit University
Bhubaneswar,Odisha |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Rashmi ranjita parhi |
KIMS |
PBMH,KIMS,CAMPUS-5,KIIT DEEMED TO BE UNIVERSITY,BBSR,ODISHA
Khordha
ORISSA |
9776531827
parhi.rashmiranjita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,KIMS,KIIT DEEMED-TO-BE-UNIVERSITY,BBSR-24 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: F988||Other specified behavioral and emotional disorders with onset usually occurring in childhood and adolescence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
yakson touch and kinesthetic stimulation |
yakson therapeutic touch with 6 steps of kinesthetic stimulation for 15 min. B.D for 3days. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
90.00 Day(s) |
| Gender |
Both |
| Details |
Neonates with low birth weight
Neonates aged 26-37 weeks admitted to the NICU
Neonates with no congenital anomalies
Neonates with five minute APGAR SCORING greater than 6
|
|
| ExclusionCriteria |
| Details |
Medically unstable Neonates.
Neonates with ventilator Supports.
History of surgery. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Behavioral status and Vital parameters of preterm neonates |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain response |
4months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
29/04/2019 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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)?
|
|
Brief Summary
|
The preterm neonates move to a smaller degree as compared to the full term newborns. In high risk neonates there is increase chances of appearance of developmental impairments in later stage of development. Stimulation given at an early stage to neonates can alter the growth of the brain cells ,improve adaptive behavior and thus the age appropriate development is likely to be achieved. Yakson therapy which one is korean therapeutic touch with kinesthetic stimulation to the preterm neonates who are highly susceptible for the developmental delay for the in later-life will help for avoidance of those conditions |