Health Condition 1: F70- Mild intellectual disabilities Health Condition 2: F71- Moderate intellectual disabilities
Conditions
Interventions
Intervention1: Structured Raga Based Instrumental Flute Music: Specially curated 10 min structured Indian classical flute music audio using Raga
Hansdhwani, Vrindavani Sarang, Ahir Bhairav and Yaman
Sponsors
KM Shah Dental College
Eligibility
Inclusion criteria
Inclusion criteria: INCLUSION CRITERIA: A. Healthy Children 1. Children aged 6 to 12 years. 2. Children without any diagnosed intellectual, developmental, psychological, or systemic disorders. 3. Children requiring preventive dental treatment, such as pit and fissure sealants and/or topical fluoride application. 4. Children with no previous adverse or traumatic dental experiences, as reported by parents or caregivers. 5. Children with hearing acuity within normal limits, classified according to the World Health Organization hearing loss classification (2016).17 6. Children whose parents or legal guardians provide written informed consent and who demonstrate basic willingness to participate in the study. 7. Children exhibiting Frankl Behavior Rating Scale Score 3 (Positive) as assessed at their first dental visit. B. Children with Mild / Moderate Intellectual Disability Children aged 6 to 12 years. Children diagnosed with mild or moderate intellectual disability as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-V TR), published by the American Psychiatric Association (revised in 2022)18. Children requiring preventive dental treatment, such as pit and fissure sealants and/or topical fluoride application. Children with no history of severe adverse or traumatic dental experiences, as reported by parents or caregivers. Children with hearing acuity within normal limits, classified according to the World Health Organization hearing loss classification (revised in 2021)17. Children whose parents or legal guardians provide written informed consent and whose caregivers confirm the child s ability to tolerate headphone-based audio intervention.
Exclusion criteria
Exclusion criteria: A. Healthy Children 1. Children currently receiving psychotropic, anxiolytic, sedative, or centrally acting medications. 2. Presence of acute dental pain, oral infection, or dental emergency conditions at the time of examination. 3. Children with systemic diseases or medical conditions known to affect salivary secretion or autonomic responses. B. Children with Mild /Moderate Intellectual Disability. 1. Children currently receiving psychotropic, anxiolytic, sedative, or centrally acting medications that may influence anxiety or salivary biomarkers. 2. Presence of acute dental pain, oral infection, or emergency dental conditions at the time of examination. 3. Children with systemic diseases or medical conditions known to affect salivary secretion or stress responses.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of change in Anxiety Levels using by measuring Salivary Alpha-Amylase levels, SpO2, Pulse rate and Venham s Clinical Anxiety Rating Scale scores.Timepoint: 1. Baseline reading - immediately before the introduction of audioanalgesia 2. Post- operative reading : Immediately After retraction of audioanalgesia post dental procedure completion. | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Pratik Kariya
K.M. Shah Dental College, Sumandeep Vidyapeeth deemed to be University
Outcome results
None listed