|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
CTRI |
|
Last refreshed on:
|
29 April 2024 |
|
Main ID: |
CTRI/2024/04/066020 |
|
Date of registration:
|
19-04-2024 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Pain Reduction In Vaccine Administration Using An Anesthetic Vibrational Device
|
|
Scientific title:
|
To Study The Efficacy Of A Novel Vibrational Anesthesia Device For Reducing Pain Of Vaccination Including COVID 19 And Improving The Quality Of Life - NIL |
|
Date of first enrolment:
|
30-04-2024 |
|
Target sample size:
|
1000 |
|
Recruitment status: |
Not Yet Recruiting |
|
URL:
|
http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=78673 |
|
Study type:
|
Interventional |
|
Study design:
|
Randomized, Parallel Group, Active Controlled Trial Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
India
| | | | | | | |
|
Contacts
|
|
Name:
|
Dr Namratha Puttur
|
|
Address:
|
Department of Dermatology Dr D Y Patil Medical College Hospital and Research Centre Pimpri Pune 411018
411018
Pune, MAHARASHTRA
India |
|
Telephone:
|
8867757806 |
|
Email:
|
putturnamratha@gmail.com |
|
Affiliation:
|
Dr D Y Patil Medical College Hospital and Research Centre |
|
|
Name:
|
Bhavika Rathi
|
|
Address:
|
Department of Dermatology Dr D Y Patil Medical College Hospital and Research Centre Pimpri Pune 411018
411018
Pune, MAHARASHTRA
India |
|
Telephone:
|
8867757806 |
|
Email:
|
putturnamratha@gmail.com |
|
Affiliation:
|
Dr D Y Patil Medical College Hospital and Research Centre |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: Individuals needing vaccine administration.
Exclusion criteria: Pregnant and lactating women.
Age minimum:
Age maximum:
Gender:
|
|
Health Condition(s) or Problem(s) studied
|
|
Health Condition 1: X- New Technology
|
|
Intervention(s)
|
Intervention1: Vibrational anesthesia device being used once at the time of injection: A Novel Vibrational Anesthesia Device will be used For Reducing Pain Of Vaccination Including COVID 19 And Improving The Quality Of Life
The device will be used on non injecting hand of the injector and the vibration from the device will be allowed to touch the surrounding area of site of injection
Control Intervention1: Conventional Injection administration: Conventional method of injecting vaccines
method-tightening of skin and a needle insertion
without use of any device
mode of injection can be intravenous, intramuscular, subcutaneous , intradermal
|
|
Primary Outcome(s)
|
|
Decrease amount of pain felt at the time of vaccinationTimepoint: At time of vaccination and at 6 months
|
|
Secondary Outcome(s)
|
|
Decreased pain felt at vaccination according to pain scaleTimepoint: In 3 months
|
|
Source(s) of Monetary Support
|
|
Department of Dermatology Dr. D. Y Patil Medical College Hospital and Research Centre Pimpri, Pune 411018
|
|
Ethics review
|
Status: Approved
Approval date: 28/09/2022
Contact:
ETHICS COMMITTEE, Dr D Y Patil Vidyapeeth, Pune
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|