| CTRI Number |
CTRI/2024/12/077592 [Registered on: 03/12/2024] Trial Registered Prospectively |
| Last Modified On: |
02/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [use of white noise in a recorder] |
| Study Design |
Other |
|
Public Title of Study
|
white noise and maternal touch on pain among the neonates a clinical study. |
|
Scientific Title of Study
|
Impact of white noise and mothers touch on pain among the neonate in a selected hospital at Mangaluru |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Glane Azeta Dsouza |
| Designation |
3rd Bsc Nursing student |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller college of Nursing
3rd year BSc. Nursing student.
first floor.
Kankanady
Dakshina Kannada
Mangalore 575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9902670775 |
| Fax |
|
| Email |
sr.glane26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPramila Dsouza |
| Designation |
Proffesor department of OBG |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller college of Nursing
Kankanady
department of OBG
Professor and HOD
Dakshina Kannada
Mangalore 575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9341889198 |
| Fax |
|
| Email |
pramiladsouza@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
DrPramila Dsouza |
| Designation |
Proffesor department of OBG |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller college of Nursing
Kankanady
Department of OBG
Professor and HOD
second floor
Dakshina Kannada
Mangalore 575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9341889198 |
| Fax |
|
| Email |
pramiladsouza@fathermuller.in |
|
|
Source of Monetary or Material Support
|
| Father Muller Medical college hospital Kankanady,Mangalore.
Postnatal ward and NICU. |
| RGUHS grant |
|
|
Primary Sponsor
|
| Name |
Glane Azeta Dsouza |
| Address |
Father Muller College of Nursing
Kankanady
Dakshina Kannada
Mangalore 575002 |
| Type of Sponsor |
Other [self.the Primary investigator. Other- co-investigator] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrPramila Dsouza |
Father muller medical college hospital |
Glane Azeta dsouza
Father Muller Medical college hospital Dakshina Kannada
Mangalore
NUMBER OF SITES OF STUDY 2
Postnatal ward and NICU
first floor of the hospital
Dakshina Kannada
KARNATAKA |
9902670775
sr.glane26@gmail.com |
| Glane Azeta Dsouza |
Father muller medical college hospital |
Glane Azeta Dsouza
Father Muller Medical College Hospital
Kankanady Mangalore 575002
Antenatal general ward and NICU first floor
Dakshina Kannada
KARNATAKA |
9902670995
sr.glane26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethic Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
new born babies undergoing blood investigations |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
true experimental with post test design only
use of white noise device .comparator not applicable
|
white noise device will be used for the babies during painful procedures. Pain is assessed using neonatal pain scale.
duration of such intervention is for 3 minutes for a baby.
comparator not applicable |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
new born with gestational age of 37 to 42 weeks
birth weight within normal range of 2500 to 4000 grams
Apgar score 8 and above at 1 and 5 minutes
babies who pass the hearing test |
|
| ExclusionCriteria |
| Details |
babies with signs of disease and congenital anomalies.
babies with history of invasive procedures such as IV fluids,blood products,or any other.
babies who have undergone any kind of invasive procedures for the last one hour before the sample collection. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduced level of pain and crying time by using the neonatal infant pain scale. |
reduced level of pain and crying time by using the neonatal infant pain scale after the painful procedure on neonate after 3 minutes of duration. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduced level of pain & crying time by using the neonatal infant pain scale. |
reduced level of pain & crying time by using the neonatal infant pain scale after the painful procedure on neonate after 3 minutes of duration. |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
28/12/2024 |
| 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 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response (Others) -
- For what types of analyses will this data be available?
Response (Others) -
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 15-11-2025 and end date provided 15-11-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Our protocol impact of white noise and mothers’ touch on pain among the newborn aims at reducing the pain in the newborn during the routine blood collection for any investigation. Our study uses white noise, a mixture of sound waves that gives a continuous monotonous sound in the form of uterine sound that can soothe the crying baby. study hypothesis is, that there will be a significant difference in the level of pain between white noise and the mother’s touch. |