| CTRI Number |
CTRI/2020/12/029710 [Registered on: 10/12/2020] Trial Registered Prospectively |
| Last Modified On: |
28/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
New vibration device Application in terms outcome of reduction of injection pain in children–A Randomized Controlled Trial |
|
Scientific Title of Study
|
TO ASSESS THE EFFICACY OF VIBRATION DEVICE IN REDUCTION OF INJECTION PAIN AMONG CHILDREN |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mrs Archana Maurya |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute Of Medical Sciences Deemed to be University |
| Address |
Smt Radhikabai Meghe Memorial College Of Nursing Sawangi
Meghe Wardha
Department of Child Health Nursing
Smt Radhikabai Meghe Memorial College of Nursing y Sawangi Meghe Wardha 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9422903004 |
| Fax |
|
| Email |
archanatej95@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sr Tessy Sebastian |
| Designation |
Professor & Nursing director |
| Affiliation |
Datta Meghe Institute Of Medical Sciences Deemed to be University |
| Address |
Smt Radhikabai Meghe Memorial College Of Nursing Sawangi
Meghe Wardha
Department of Mental Health Nursing
Smt. RadhikabaiMeghe Memorial College Of Nursing,DattaMeghe Institute Of Medical Sciences (Deemed to be University ),
Sawangi Meghe
Wardha 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9604607913 |
| Fax |
|
| Email |
srtessy1964@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Archana Maurya |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute Of Medical Sciences Deemed to be University |
| Address |
Smt Radhikabai Meghe Memorial College Of Nursing Sawangi
Meghe Wardha
Smt Radhikabai Meghe Memorial College Of Nursing Sawangi
Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9422903004 |
| Fax |
|
| Email |
archanatej95@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Medical sciences (Deemed to be University), Acharya Vinoba Bhave
Rural Hospital Sawangi (Meghe) wardha |
|
|
Primary Sponsor
|
| Name |
Prof Archana Maurya |
| Address |
Dept of Child Health Nursing
Smt Radhikabai Meghe Memorial College Of Nursing,
Datta Meghe Institute Of Medical Sciences Deemed to be University Sawangi M Wardha
MAHARASHTRA 442001
|
| Type of Sponsor |
Other [Other [Self sponsored]] |
|
|
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 |
| Mrs Archana Maurya |
Acharya Vinoba Bhave Rural Hospital |
DMIMS Campus Sawangi (Meghe) Wardha 442003 MAHARASHTRA
Pediatric Unit
Wardha
MAHARASHTRA |
9422903004
archanatej95@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute Of medical Science (Deemed to be University) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Injection pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional method |
Control group which follows the conventional method
Rub by palm on injection site |
| Intervention |
New Vibration device |
Develop new vibration device and applicable during injection procedure
1 ASSESSMENT & PLANNING PHASE The investigator will visit the AVBR hospital in advance and obtain the necessary permission from the concerned authorities The investigator will introduce him and inform the child’s parent about the nature of the study so as to ensure better co-operation during the data collection
2 IMPLEMENTATION PHASE
Vibration device is placed by attaching it to the injection site holding it in place as close as possible above the needle insertion site and activate The device has to be kept in place throughout the procedure In experimental group and control group only rub by palm on injection site no intervention will be given during administration of injection in children
3 EVALUATION PHASE The outcome measures pain in children during injection and were recorded and assessed by a blinded observer
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Child who are in pediatric unit.
Those children are fully conscious.
Parent’s who have willing to their child participate in study
|
|
| ExclusionCriteria |
| Details |
Those children are admitted in PICU with ventilator support.
Those children are mentally handicaps.
Extensive hospitalization for chronic illness
Those children having neuro-behaviour disorders (Paralysis, Cerebral palsy)
Those children having behaviour problem (Autism, temper tantrum, ADHD).
Those children having injection side abscess or any complication.
Past history of surgery
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
assess reduction of injection pain in children (Wong-Baker FACES pain rating scale).
assess anxiety level through Children’s emotional behaviour scale |
Before, during and after injection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pulse or Heart Rate
SpO2 saturation
Respiration rate
|
Before, during and after injection |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
01/01/2021 |
| 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="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
To assess the efficacy of Vibration device in reduction of Injection pain in children. This study is a randomized, participant blinde, sealed opaque envelope, two group one control group and interventional trail comparing assess the pain level, anxiety level respiration heart rate and SpO2 . Study have three phases –1. ASSESSMENT & PLANNING PHASE: The investigator will visit the AVBR hospital in advance and obtain the necessary permission from the concerned authorities. The investigator will introduce him and inform the child’s parent about the nature of the study so as to ensure better co-operation during the data collection.2. IMPLEMENTATION PHASE: Vibration device is placed by attaching it to the injection site holding it in place, as close as possible above the needle insertion site and activate The device has to be kept in place throughout the procedure In experimental group and control group, only rub by palm on injection site no intervention will be given during administration of injection in children.3. EVALUATION PHASE: The outcome measures pain in children during injection and were recorded and assessed by a blinded observer. |