Skip to content

Effect of brainwave audio-visual relaxation therapy on pain during dental injection in children.

Effectiveness of Brainwave Entrainment In Altering Pain Perception During Mandibular Block Anesthesia In Children: A Randomized Controlled Trial - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/06/111648
Enrollment
190
Registered
2026-06-01
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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: K042- Pulp degeneration Health Condition 6: K040- Pulpitis

Interventions

Intervention1: Theta-frequency audiovisual brainwave entrainment using binaural beats.: Participants will receive theta-frequency (4 8 Hz) audiovisual brainwave entrainment using the DAVID Delight Pro

Sponsors

Areef Farah Shehani
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 6 12 years Requiring unilateral inferior alveolar nerve block for restorative, endodontic, or extraction procedures Frankl behavior rating score 2 or 3 Children without neurological, developmental, or behavioral disorders

Exclusion criteria

Exclusion criteria: Medical conditions affecting pain perception Visual or auditory impairment Current use of anxiolytics or analgesics Bilateral mandibular procedures Previous experience with local anesthesia administration

Design outcomes

Primary

MeasureTime frame
Alteration in pain perception during inferior alveolar nerve block administration, assessed using Numeric Pain Rating Scale, Visual Analog Scale, and Revised FLACC Scale.Timepoint: At 0 minutes, before initiation of brainwave entrainment/intervention and local anesthesia administration. After 5 mins- During inferior alveolar nerve block administration. At the end- Immediately after completion of inferior alveolar nerve block administration.

Secondary

MeasureTime frame
Change in physiological anxiety response assessed using heart rate & blood pressure measurements.Timepoint: At 0 minutes, Before initiation of intervention & local anaesthesia administration. At 5 minutes, During inferior alveolar nerve block administration. At end, Immediately after completion of inferior alveolar nerve block administration.;Behavioral cooperation assessed using Frankl Behavior Rating Scale.Timepoint: At 0 minutes, before initiation of the procedure. At 5 minutes, During inferior alveolar nerve block administration. At the end, Immediately after completion of the procedure.

Countries

India

Contacts

Public ContactAreef Farah Shehani

Saveetha Institute of Medical and Technical Sciences (SIMATS)

mahesh@saveetha.com9840322728

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026