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The effect of a novel device on pain during venous line placement in children aged 7 -12 years

Effects of an immersive virtual reality Intervention on pain and anxiety during venipuncture in children aged 7-12 years-a three arm concurrent parallel design randomized control trial - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094898
Enrollment
90
Registered
2025-09-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: 2- Placement

Interventions

Intervention1: Virtual Reality Device: A Virtual Reality Device will be used on the child during Venipuncture, which will distract the child and reduce their pain and anxiety levels during the procedu

Sponsors

Mahatma Gandhi medical College and Research Institute,Sri Balaji Vidyapeeth University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All children admitted to the Pediatric ward aged 7-12 years in whom venipuncture is planned electively 2. Child should have a Glasgow Coma Scale of 15/15.

Exclusion criteria

Exclusion criteria: 1. Children with pre-existing photosensitive epilepsy, vertigo, migraine. 2. Children with moderate or severe intellectual disability, and developmental delay. 3. Physical factors preventing placement of the VR headset (e.g: wound on head or face). 4. Child with previous history of syncope/vertigo during adventure games

Design outcomes

Primary

MeasureTime frame
To compare the mean differences in child, parent and clinician-reported pain scores as measured by Faces Pain Scale-Revised scale and Visual Analogue scale amongst Immersive Virtual Reality, tablet video, and standard procedure group during venipuncture.Timepoint: T1 is 10 moinutes prior

Secondary

MeasureTime frame
To determine the child reported level of immersion of VR in the Immersive Virtual Reality group using the Gold Rizzo Immersion and Presence (GRIP) inventory.Timepoint: 30 mins

Countries

India

Contacts

Public ContactDr Vangeti Rohitha Reddy

Mahatma Gandhi Medical College and Research Institute

dr.vikneswari@gmail.com9486899335

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026