None listed
Conditions
Interventions
Sponsors
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
| Measure | Time 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
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Narayana Dental College and Hospital, Nellore