Effectiveness of simulated breathing musical soft toy in reducing dental anxiety during restorative procedures in 4-8-year-old children

Effectiveness of simulated breathing musical soft toy in alleviating dental anxiety during restorative procedures in 4-8-year old children: a randomized clinical trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/102217

Enrollment

Registered

2026-01-28

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Health Condition 1: F419- Anxiety disorder, unspecified

Interventions

Intervention1: Simulated breathing musical soft toy group: A simulated breathing musical soft toy is an innovative approach. It combines a variety of sensory inputs, including tactile comfort from it

Eligibility

Inclusion criteria

Inclusion criteria: The study includes healthy children aged 4 8 years who had no prior dental experience, presented with ICDAS scores of 1, 2, or 3, and exhibited Frankl s behavior rating of 2 and 3.

Exclusion criteria

Exclusion criteria: 1. Children with known anxiety disorders 2. Medically compromised 3. Past dental history

Design outcomes

Primary

Measure	Time frame
To evaluate the effectiveness of a simulated breathing musical soft toy in reducing anxiety during dental restorative procedures in children aged 4 8 years. Timepoint: 2nd visit	—

Secondary

Measure	Time frame
To evaluate the acceptance of a simulated-breathing musical soft toy in children aged 4 to 8 years.Timepoint: 2nd visit after treatment	—

Countries

India

Contacts

Public ContactPurva Chaudhari

Ranjeet Deshmukh Dental College and Research Center

PurvaChowdhari@gmail.com8600604334

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026