| CTRI Number |
CTRI/2023/12/060680 [Registered on: 22/12/2023] Trial Registered Prospectively |
| Last Modified On: |
20/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of a game, AINAR on needle fear in blood donors. |
|
Scientific Title of Study
|
A randomized controlled trial to assess the effectiveness of Artificial intelligence based game AINAR to conquer needle fear in blood donors. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gopal Kumar Patidar |
| Designation |
Associate Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room No 1
Blood Center
Cardio Neuro Center
AIIMS New Delhi
South West
DELHI
110029
India |
| Phone |
9781089405 |
| Fax |
|
| Email |
drgpatidar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gopal Kumar Patidar |
| Designation |
Associate Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room No 1
Blood Center
Cardio Neuro Center
AIIMS New Delhi
South West
DELHI
110029
India |
| Phone |
9781089405 |
| Fax |
|
| Email |
drgpatidar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Radheshyam Meher |
| Designation |
Senior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Room No 1
Blood Center
Cardio Neuro Center
AIIMS New Delhi
South West
DELHI
110029
India |
| Phone |
7894989487 |
| Fax |
|
| Email |
Radheshyam2163@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, New Delhi |
| Address |
Ansari Nagar
New Delhi
110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Gopal Kumar Patidar |
All India institute of Medical Sciences, New Delhi |
CNC Blood Center
Dept of Transfusion Medicine
AIIMS New Delhi
South West
DELHI |
9781089405
drgpatidar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NORMAL, HEALTHY |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AINAR game |
In this group, donors will be provided with smartphone/iPad and will be instructed to play the AINAR game with the assistance of one dedicated person during needle insertion(1-2min) and during needle removal (1-2min.) (Total duration of intervention is approximately 2-3min only). |
| Comparator Agent |
Control group |
In this group, donors will be advised to donate as per the routine donation practice, without any intervention. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.All young male and female donors aged between 18-30 years
2.All first-time donors
3.Repeat donors with a history of VVR in previous donation
|
|
| ExclusionCriteria |
| Details |
1.Donors not giving consent
2.Repeat donors with ≥2 VVRs in previous donations
3.Donors with incomplete donation except for VVR
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Needle fear and frequency of vasovagal reaction in blood donors |
At baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effectiveness of AINAR game in VVR prevention
Association of Needle fear with VVR |
At the end of the study |
|
|
Target Sample Size
|
Total Sample Size="3000"
Sample Size from India="3000"
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)
|
01/01/2024 |
| 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 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
|
This study is a parallel group randomized trial assessing the effectiveness of a artificial intelligence based game , AINAR to conquer the needle fear in blood donors. This sample size will be 1500 each in the AINAR game group as well as in the control group over a period of 1 year in a blood center in India. The primary outcome will be the assessment of needle fear and immediate type vasovagal reaction during blood donation procedure. The secondary outcome will be the assessment of effectiveness of AINAR game in the prevention of VVR and association of needle fear with VVR. |