Assessment of Tickle Teddy Technique and Melodic Mouth Magic on Pain and Anxiety in Children Receiving Local Anesthesia

Phase 1/2

Not yet recruiting

Conditions: Pulpitis,

Registration Number: CTRI/2025/05/086410

Lead Sponsor: Pragati Pareek

Brief Summary: This randomized controlled clinical trial aims to evaluate the effectiveness of two behavioral distraction techniques—Tickle Teddy Technique (a vibratory device) and Melodic Mouth Magic (music distraction with rhythmic humming)—on pain perception and anxiety levels in children aged 4 to 10 years receiving local anesthesia for dental procedures. A total of 90 healthy children meeting specific inclusion criteria will be randomly assigned to one of three groups: Tickle Teddy, Melodic Mouth Magic, or a control group receiving routine local anesthesia without distraction. Pain will be assessed immediately after anesthesia administration using the Wong-Baker FACES Pain Scale, while anxiety will be measured before, during, and after the procedure using the Facial Image Scale and heart rate monitoring. The study is single-blinded, with the outcome assessor blinded to group allocation, and will be conducted over a period of six months at a single site in India.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 90

Inclusion Criteria

ASA I to IV status (Healthy) Requires local anaesthesia for dental treatment Frankl behaviour Rating 3 or 4 Parents willing to provide informed consent.

Exclusion Criteria

Systemic illness or behaviour/developmental disorders allergic to local anesthetic previous dental injection experience frankl rating 1 or 2.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain perception using Wong Baker FACES Scale	Pain perception using Wong Baker FACES Scale at BASELINE- Pretreatment - Posttreatment

Secondary Outcome Measures

Name	Time	Method
Anxiety levels (Facial Image Scale and heart rate )	Before, during , and after LA adminstration

Trial Locations

Locations (1): Saveetha Dental College
🇮🇳
Chennai, TAMIL NADU, India
Saveetha Dental College
🇮🇳Chennai, TAMIL NADU, India
DRPOOJA VR
Principal investigator
8940844133
poojavr.sdc@saveetha.com