Skip to main content
Clinical Trials/CTRI/2024/10/075766
CTRI/2024/10/075766RecruitingPhase 2

Comparative evaluation of two different audio-visual distraction techniques for behaviour management: A randomized control trial.

Dr Oshin Pragya Lepcha1 site in 1 country25 target enrollmentStarted: November 1, 2024Last updated:

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Sponsor
Enrollment
25
Locations
1
Primary Endpoint
To compare and evaluate the effectiveness of

Study Overview

Brief Summary

This randomized split-mouth clinical trial aims to compare the effectiveness of virtual reality (VR) glasses and iPad-based audio-visual distraction techniques in managing anxiety and pain during vital pulp therapy in children aged 7-10 years. The study will be conducted at the Department of Pedodontics and Preventive Dentistry, Christian Dental College, Ludhiana. A total of 25 cooperative children with bilateral carious primary molars requiring pulp therapy will be included. Each child will experience both distraction techniques, with outcomes measured through heart rate, oxygen saturation, and Wong-Baker Faces Pain Rating Scale at various stages of the dental procedure. The study aims to identify which technique better reduces anxiety and pain in pediatric patients, ultimately improving their overall dental experience.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
None

Eligibility Criteria

Ages
7.00 Year(s) to 10.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • A healthy child with bilateral carious primary molars requiring pulp therapy
  • Child aged 7-10 years
  • Exhibiting Frankl positive or definitely positive.

Exclusion Criteria

  • Children with special health care needs
  • Uncooperative child(Frankl negative or definitely negative).

Outcomes

Primary Outcomes

To compare and evaluate the effectiveness of

Time Frame: 5 minutes before treatment | During administration of local anesthesia | During caries removal | During biomechanical preparation | During obturation | During post-obturation restoration | 5 minutes post-operatively

virtual reality as an attention distraction technique for pain management and assessment in

Time Frame: 5 minutes before treatment | During administration of local anesthesia | During caries removal | During biomechanical preparation | During obturation | During post-obturation restoration | 5 minutes post-operatively

children undergoing pulp therapy

Time Frame: 5 minutes before treatment | During administration of local anesthesia | During caries removal | During biomechanical preparation | During obturation | During post-obturation restoration | 5 minutes post-operatively

Secondary Outcomes

  • To compare and evaluate the changes in(Heart rate)

Investigators

Sponsor
Dr Oshin Pragya Lepcha
Sponsor Class
Other [Self Sponsored]
Responsible Party
Principal Investigator
Principal Investigator

Dr Oshin Pragya Lepcha

Christian Dental College

Study Sites (1)

Loading locations...

Similar Trials