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study on pain relief with external cold and vibrating device in children with needle pain during blood tests or cannulation.

Clinical efficacy of external cold and vibrating device in decreasing pain in children undergoing venipuncture in paediatric hospital - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094853
Enrollment
72
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: F01-F99- Mental, Behavioral and Neurodevelopmental disorders

Interventions

Intervention1: External cold and vibrating device: External cold and vibrating device used in our study is called BUZZY which is class 1 FDA approved, over the counter low grade device which has vibra

Sponsors

inira gandhi institute of child health
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: presence of atleast one parent/ care giver

Exclusion criteria

Exclusion criteria: Cghildren with significant altered emotional state, cognitive dysfunction, who refuse to wear device, with bleeding disorders, with neuropathy/ nerve damage, who are critically ill/ unstable. absence of atleast one parent or caregiver, lack of parental consent

Design outcomes

Primary

MeasureTime frame
To evaluate efficacy of external cold and vibrating device in decreasing pain during venipuncturr compared to standard care in tge age group of 3 to 12 yearts admitted in paediatric surgical wards as assessed by modified wong baker scale and numerical rating scales of pain.Timepoint: During or immidiately after the procedure, once only.

Secondary

MeasureTime frame
To assess the acceptance of the device using appropriate likert questionnaire and to assess the level of anxiety in children undergoing cannulation using children fear scaleTimepoint: During or immediately after the procedure, once only

Countries

India

Contacts

Public ContactDr Sharadha M

indira gandhi institute of child health, bengaluru

www.sharadharadhamanju@gmail.com09148884706

Outcome results

None listed

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