CTRI/2023/12/060680Not yet recruitingNot Applicable
A randomized controlled trial to assess the effectiveness of Artificial intelligence based game AINAR to conquer needle fear in blood donors.
All India Institute of Medical Sciences, New Delhi1 site in 1 country3,000 target enrollmentStarted: January 1, 2024Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 3,000
- Locations
- 1
- Primary Endpoint
- Needle fear and frequency of vasovagal reaction in blood donors
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 30.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •1.Donors not giving consent 2.Repeat donors with ≥2 VVRs in previous donations 3.Donors with incomplete donation except for VVR.
Outcomes
Primary Outcomes
Needle fear and frequency of vasovagal reaction in blood donors
Time Frame: At baseline.
Secondary Outcomes
- Effectiveness of AINAR game in VVR prevention(Association of Needle fear with VVR)
Investigators
Gopal Kumar Patidar
AIIMS New Delhi
Study Sites (1)
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