| CTRI Number |
CTRI/2023/10/059254 [Registered on: 30/10/2023] Trial Registered Prospectively |
| Last Modified On: |
27/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Success Of Massager Combined With Ice To Reduce Discomfort During Blood Withdrawl Procedure |
|
Scientific Title of Study
|
Efficacy of Cryovibrator for painless phlebotomy in adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Devika Rani Mamidipaka |
| Designation |
Undergraduate student |
| Affiliation |
Vishnu Dental College |
| Address |
Vishnu Dental College,Vishnupur,Bhimavaram,West Godavari District ,Andhra Pradesh,India
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
8500730409 |
| Fax |
|
| Email |
devika.mamidipaka@vdc.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
SpandanaCheeli |
| Designation |
Senior Lecturer; Pedodontics and Preventive Dentistry |
| Affiliation |
Vishnu Dental College |
| Address |
Vishnu Dental College,Vishnupur,Bhimavaram,West Godavari District ,Andhra Pradesh,India
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9177182909 |
| Fax |
|
| Email |
spandana.ch@vdc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
SpandanaCheeli |
| Designation |
Senior Lecturer; Pedodontics and Preventive Dentistry |
| Affiliation |
Vishnu Dental College |
| Address |
Vishnu Dental College,Vishnupur,Bhimavaram,West Godavari District ,Andhra Pradesh,India
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9177182909 |
| Fax |
|
| Email |
spandana.ch@vdc.edu.in |
|
|
Source of Monetary or Material Support
|
| Vishnu dental college,vishnupur,Bhimavaram,west Godavari district ,Andhra Pradesh,india |
|
|
Primary Sponsor
|
| Name |
Vishnu Dental College |
| Address |
Vishnu Dental College,Vishnupur,Bhimavaram,West Godavari District ,Andhra Pradesh,india |
| Type of Sponsor |
Other [Private Dental 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 |
| Dr CH spandana |
Vishnu Dental College |
Room no 5 ,Department of Pedodontics and Preventive Dentistry,Vishnu Dental College,Vishnupur,Bhimavaram,West Godavari District ,Andhra Pradesh,india
West Godavari
ANDHRA PRADESH |
9177182909
spandana.ch@vdc.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vishnu Dental College, Bhimavaram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Phlebotomy With Cryo Vibrator |
Tourniquet Is Placed 2-5 cms Above Venipuncture site.Cryovibrator is Placed Above 2-4 cms And Phlebotomy is Done |
| Intervention |
Phlebotomy without Cryovibrator |
Torniquet is placed 2-5 cms above venipuncture site and phlebotomy is done without Cryovibrator |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1)Adult patients aged between 25-45 years
2)Patients Who Require Therapeutic Dental Procedurs
3)Patients who require blood investigation for therapeutic purposes |
|
| ExclusionCriteria |
| Details |
1)Evidence of cellulitis or abscess
2)Venous fibrosis on palpation
3)Presence of a heamatoma
4)Presence of vascular shunt or graft
5)Presence of vascular access device
6)Patient who are not willing to give consent
7)Patients who are under analgesics |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain Assessment |
Postoperatively 0-5 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Anxiety assesment |
Postoperatively 0-5 minutes |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116"
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)
|
07/11/2023 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Participants will be divided into two groups group 1 :control group 2:cryovibrator in group 1 area of venipuncture will be gently wiped with spirit cotton in circulatory motion to clean the area whereas in group 2 after wiping area of venipuncture cryovibrator device which consists of icepack combined with power driven mini vibrator massager will be placed 2-5 Cms above venipuncture site for 60 seconds and phlebotomy procedure will be performed for trained profesionals.The subjective assessment of pain response for both groups will be carried out using Wong Baker Faces Pain Rating Scale |