Using Different Sounds to Help Children Stay Calm and Comfortable During Dental Injections

Assessment of Different Coloured Noises as Non-Pharmacological Distraction Tools in Alleviating Anxiety and Pain during Local Anesthesia in Children: A Randomized Clinical Trial - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/094045

Enrollment

Registered

2025-09-01

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

None listed

Interventions

Intervention1: White noise, Pink noise and Brown noise: Children in Group 1 will listen to white noise through headphones starting 1 to 2 minutes before local anesthesia administration and continuing

Eligibility

Inclusion criteria

Inclusion criteria: 6-11 years old children Children who are willing to participate in the study. Children requiring LA for dental procedures Children with no cognitive disorders Children whose parents/guardians provide written informed consent and who provide child assent.

Exclusion criteria

Exclusion criteria: Children with hearing impairments or auditory processing disorders Those who are not willing to hear noises Special health care need Children Recent trauma to oral tissues Children with systemic illnesses or conditions contraindicating dental treatment. Children with a history of hypersensitivity reactions to anaesthetic agent

Design outcomes

Primary

Measure	Time frame
The primary outcome of the study is the reduction in pain and anxiety levels during local anesthesia administration in children, assessed using the Animated Emoji Scale (before and after the procedure), the Sound-Eye-Motor (SEM) Scale (during the procedure), and the Oucher?s Pain Scale (after the procedure).Timepoint: Assessments will be carried out at Baseline (before LA administration) Immediate (during LA administration) Immediate post-intervention (after LA administration)	—

Measure

Time frame

The primary outcome of the study is the reduction in pain and anxiety levels during local anesthesia administration in children, assessed using the Animated Emoji Scale (before and after the procedure), the Sound-Eye-Motor (SEM) Scale (during the procedure), and the Oucher?s Pain Scale (after the procedure).Timepoint: Assessments will be carried out at Baseline (before LA administration) Immediate (during LA administration) Immediate post-intervention (after LA administration)

—

Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactGanganapalli Reddy Sravya

Narayana Dental College and Hospital, Nellore

nimskrishna2007@gmail.com9440206976

Outcome results