Comparative evaluation of different audio distraction therapies during extraction procedures in children- A Randomised Controlled Trial.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Satisfactory effectiveness of music as an audio distraction therapy during simple extraction procedures in children.
Study Overview
Brief Summary
This study is a randomized, single-blinded, single-centre trial comparing the effectiveness of four types of audio distraction therapies/techniques during simple extraction procedures in children in the age group of 6-10 years in the Department of Pediatric and Preventive Dentistry, MAIDS. The primary outcome will depict the satisfactory effectiveness of music as an audio distraction therapy during simple extraction procedures in children. It will be evaluated at three points, ie., preoperatively, during LA administration and during extraction procedure. The need for this study arises from the lack of comprehensive data comparing these types of audio distraction therapies.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 6.00 Year(s) to 10.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Children in the age group of 6 to 10 years.
- •Children having primary teeth indicated for extraction.
Exclusion Criteria
- •Children with any Special Health Care needs or systemic disease.
- •Children with any physical disabilities.
- •Children allergic to local anaesthesia.
- •Children with history of any previous dental extraction.
Outcomes
Primary Outcomes
Satisfactory effectiveness of music as an audio distraction therapy during simple extraction procedures in children.
Time Frame: Preoperative, during local anaesthesia administration and during extraction procedure.
Secondary Outcomes
- Better effectiveness of music with vocals than without vocals during simple extraction procedures in children.(Preoperative, during local anaesthesia administration and during extraction procedure.)
- Better effectiveness of music with headphones than speaker during simple extraction procedures in children.(Preoperative, during local anaesthesia administration and during extraction procedure.)
Investigators
Akansha Gupta
Maulana Azad Institute of Dental Sciences