| CTRI Number |
CTRI/2025/03/083643 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Yakson Touch Therapy vs Gentle Human Touch vs standard care] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
"Comparing the effect of Yakson Touch Therapy, Gentle Human Touch, and Standard Care on pain and physiological parameters during heel lancing in neonates in NICU." |
|
Scientific Title of Study
|
A Three-Arm Randomized Controlled Trial to compare the effectiveness of Yakson Touch Therapy versus Gentle Human Touch versus standard care on pain and physiological parameters during heel lancing procedure in neonates admitted in NICU at GGSMCH,Faridkot,Punjab. |
| Trial Acronym |
YTT VS GHT VS SC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Navpreet Kaur |
| Designation |
Postgraduate(Nursing) |
| Affiliation |
Baba Farid University of Health Sciences(Faridkot)(Faridkot) |
| Address |
University College Of Nursing near Guru Gobind Singh Medical College and Hospital Sadiq Road Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
8725833969 |
| Fax |
|
| Email |
navpreetpawar123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Vandna |
| Designation |
Associate Professor |
| Affiliation |
Baba Farid University of Health Sciences(Faridkot) |
| Address |
University College Of Nursing near Guru Gobind Singh Medical College and Hospital Sadiq Road Faridkot
opp GGS Medical College and Hospital(Faridkot)
Faridkot
PUNJAB
151203
India |
| Phone |
9878865066 |
| Fax |
|
| Email |
vandana.rana22@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amanpreet Sethi |
| Designation |
Associate Professor(Neonatology) |
| Affiliation |
Baba Farid University of Health Sciences(Faridkot) |
| Address |
Guru Gobind Singh Medical College and Hospital(Child department) Sadiq Road Faridkot Punjab
Sadiq Road, Kotakpura, GGS Medical Hospital(Faridkot)Punjab 151203
Faridkot
PUNJAB
151203
India |
| Phone |
7011371669 |
| Fax |
|
| Email |
sethi.amanpreet702@gmail.com |
|
|
Source of Monetary or Material Support
|
| University College of Nursing,Faridkot,Sadiq Road, Faridkot-151203 |
|
|
Primary Sponsor
|
| Name |
Ms Navpreet Kaur |
| Address |
University college ofNursing near Guru Gobind Singh Medical College and Hospital,Faridkot Sadiq road, Faridkot-151203 Punjab INDIA |
| Type of Sponsor |
Other [Self] |
|
|
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 Amanpreet Sethi |
Guru Gobind Singh Medical College and Hospital(GGSMCH) |
Neonatal Intensive Care Unit(NICU) 1st Floor Paediatric department,Guru Gobind Singh Medical College and Hospital(GGSMCH) Faridkot, Punjab.
Faridkot
PUNJAB |
7011371669
sethi.amanpreet702@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| "Institutional Research And Ethical Committee" Of University College of Nursing (Faridkot) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P709||Transitory disorder of carbohydrate metabolism of newborn, unspecified, (2) ICD-10 Condition: P709||Transitory disorder of carbohydrate metabolism of newborn, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Gentle Human Touch |
The fingertips of one hand,above the eyebrow line with the palm touching the neonates crown while other hand will rested on the lower abdomen of neonates encompassing the waist and the hip for 3 minutes. |
| Comparator Agent |
Standard Care |
Standard Care:-Routine care(Tucking)will be given for 3 minutes after the heel lancing procedure. |
| Intervention |
Yakson Touch Therapy |
Placing the left hand under the neonates back and right hand will placed on top of the neonates abdomen and massaged in a clockwise movement for 3 minutes,roughly 1 cm in diameter. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
1.Neonates undergoing a heel lancing procedure (blood sugar monitoring).
2.Neonates who will be having the first prick on heel.
3.Neonates who will be conscious (able to respond painful stimuli).
4. Neonates whose parents will be willing to participate. |
|
| ExclusionCriteria |
| Details |
1.Neonates who will critically ill having RDS ( on ventilator or CPAP), congenital anomaly, Intraventricular hemorrhage, History of surgery or inflammation of heel.
2.Neonates who will be under any sedatives/ anticonvulsant drugs.
3.Neonates will be undergoing heel lance procedure repeated within 4 hours. |
|
|
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 |
| Pain assessment using standardized scale(Neonatal Infant Pain Scale-NIPS) during heel lancing procedure. |
3 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Physiological parameters(Heart rate,Respiratory rate,saturation) |
(Time 0 minutes)Baseline data before the intervention & immediately after the intervention(Time 3 minutes) |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
11/04/2025 |
| 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="0"
Months="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The study will be conducted to compare the effectiveness of yakson touch therapy versus gentle human touch versus standard care on pain and physiological parameters during heel lancing procedure in neonates admitted in NICU at GGSMCH, Faridkot, Punjab. The main aim of the study to compare the effectiveness of yakson touch therapy versus gentle human touch versus standard care on pain and physiological parameters in neonates admitted in NICU at GGSMCH, Faridkot, Punjab. The quantitative research approach will be used to carry out randomized control trial. The simple random sampling technique will be 72 neonates randomly allocated by SNOSE method (Group A=24, Group B=24, Group C=24) will be selected based on inclusion/exclusion criteria. The tool will consist of demographic data sheet and Neonatal Infant Pain Scale (NIPS) to assess the level of pain. |