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How an Eye Massage Device Helps Reduce Fear and Pain in Children During Dental Injections

Impact of Audio-Tactile Distraction Using an Eye Massage Device on Anxiety and Pain in Pediatric Dental Patients: A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/111406
Enrollment
66
Registered
2026-05-29
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

None listed

Interventions

Intervention1: Eye massage device along with natural sounds: Children in the intervention groups will receive an eye massage device during local anesthesia administration. In Group I, the eye massage

Sponsors

Ganganapalli Reddy Sravya
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 8 10 years who require administration of local anesthesia for painful dental procedures such as pulpectomies, root canal treatments, or extractions will be included in the study. Only children with positive or definitely positive behaviour according to the Frankl Behavior Rating Scale, who are systemically healthy and free from neurological, psychological, or auditory disorders, will be selected. Written informed consent will be obtained from parents or legal guardians, and assent will be obtained from the children wherever applicable.

Exclusion criteria

Exclusion criteria: Children who refuse to wear or are unable to tolerate the eye massage device, those presenting with acute dental pain at the time of treatment, and children with a history of seizures, visual disorders, or conditions affecting the periocular region will be excluded from the study. Children with special health care needs that may interfere with anxiety or pain assessment and those whose parents or guardians do not provide consent for participation will also be excluded.

Design outcomes

Primary

MeasureTime frame
Assessment and comparison of the effectiveness of an eye massage device combined with natural sounds and an eye massage device alone with conventional behaviour management techniques in reducing anxiety and pain during dental local anesthesia administration in children.Timepoint: The outcomes will be assessed at three time points: before the intervention and local anesthesia administration, during local anesthesia administration, and immediately after the procedure. Baseline anxiety and pulse rate will be recorded before the intervention. During local anesthesia administration, pulse rate and objective pain response will be assessed. Immediately after local anesthesia administration, subjective pain perception and post-procedure anxiety levels will be evaluated.

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDrSVSGNirmala

Narayana Dental College and Hospital, Nellore

nimskrishna2007@gmail.com9440206976

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026