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A clinical trial to study the effect of brainwave entrainment versus audio-visual distraction on acute pain perception in pediatric patients undergoing dental treatment.

A comparative evaluation of brainwave entrainment versus audio-visual distraction on acute pain perception in pediatric patients undergoing dental treatment.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/06/043020
Enrollment
210
Registered
2022-06-06
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: K041- Necrosis of pulp Health Condition 2: K049- Other and unspecified diseases ofpulp and periapical tissues Health Condition 3: K046- Periapical abscess with sinus Health Condition 4: K047- Periapical abscess without sinus Health Condition 5: K040- Pulpitis

Interventions

Intervention1: Mind Alive David Delight Plus device: Frequency- 8-12Hz, total duration- 10mins The DAVID Delight Plus is an innovative portable hand-held device that offers a non-pharmaceutical approa

Sponsors

SRM Kattankulathur Dental college
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children with general good health. No/Previous dental experience involving local anesthetic administration (Infiltration/Block)

Exclusion criteria

Exclusion criteria: Children who are having deafness or impaired hearing, blind or have a visual impairment, epileptic or have other neurological disorders, or have a history of brain injury or disability.

Design outcomes

Secondary

MeasureTime frame
Assess cooperative behaviour of paediatric patients Time duration for dental treatmentTimepoint: At 0 mins, before the start of the procedure such as pulp therapy or exaction. At 5 mins, during the procedure such as pulp therapy or exaction. At end of the procedure such as pulp therapy or extraction. It will vary from dentist to dentist.—

Primary

MeasureTime frame
Alteration in acute dental pain perception in pediatric patients undergoing dental treatment through binaural beats with visual stimulus (alpha waves) vs audio-visual distraction technique.Timepoint: Time point 1- before administering the device (david delight plus mind alive device/ audio-visual device/ AAPD guidelines on behavior management). Time point 2- after administering the device (david delight plus mind alive device/ audio-visual device/ AAPD guidelines on behavior management).—

Countries

India

Contacts

Public ContactDr Farah Shehani

SRM Institute of science and technology, SRM Kattankulathur Dental College

victorsa@srmist.edu.in9841610525

Outcome results

None listed

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