Clinical trial NCT06326307: Effectiveness of Puppet Modeling Technique on Children Undergoing Stressful Dental Procedures
Official title: Effectiveness of Puppet Modeling Technique on Children Undergoing Stressful Dental Procedures' Randomized Clinical Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavioral Guidance in Pediatric Dentistry
Keywords: behavioral guidance
Pediatric dentistry
puppet
tell show and do
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 41
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: * Group I : Children who received puppet behavior guidance during their first visit and tell-show-do guidance in their second visit, 2 weeks later. (P-TSD)
* Group II: Children who received the tell-show-do behavior guidance during their first visit and puppet behavioral guidance in their second visit, 2 weeks later.(TSD-P)
Primary purpose: TREATMENT

Brief summary: The goal of this RCT is to compare puppet modeling technique vs tell show and do on children undergoing stressful dental procedures'

* The main question\[s\] it aims to answer are:

  1. To compare the effect of puppet modeling vs tell show and do on the cooperation of children during the administration of local anesthesia.
  2. To compare the effect of puppet modeling vs tell show and do on the anxiety level of children during the administration of local anesthesia.

type of study: clinical trial participant population/health conditions: Healthy

In this randomized crossover clinical trial, study subjects were randomly allocated into two groups:

* Group I : Children who received puppet behavior guidance during their first visit and tell-show-do guidance in their second visit, 2 weeks later. (P-TSD)
* Group II : Children who received the tell-show-do behavior guidance during their first visit and puppet behavioral guidance in their second visit, 2 weeks later.(TSD-P)

Detailed description: Aim of the Study: The aim of this research is to compare the effectiveness of tell show and do (TSD) vs puppet play therapy on children's behavior during the administration of local anesthesia.

Materials and Methods: This was a randomized crossover clinical trail that was conducted at King Abdulaziz University Faculty of Dentistry for a period of 12 months starting from Jan 2023 to Dec 2023 on 41 children (aged 3-7 years) randomly divided into two groups of. Group I (23 children): Children who received the TSD behavior guidance during their first visit and puppet play therapy in their second visit 2 weeks later. Group II (18 children): Children who received puppet play therapy during their first visit and TSD guidance in their second visit 2 weeks later. The anxiety level was determined using Facial Index Scale(FIS) and Venham anxiety rating scale and pulse rate (PR) at the beginning, middle and the end of each anesthesia administration. Patient behavior was also scored using Frankl behavior rating scale (FBRS) , Venham behavior rating scale. The FLACC scale was used to assess pain.

Eligibility criteria: Inclusion Criteria:

* • Children having no previous experience of local anesthesia

  * Children aged 3-8 years old
  * Children with negative history of any particular underlying disease.

Exclusion Criteria:

* • Children who needed procedures with no local anesthesia.

  * Children who were allergic to local anesthesia.
  * Children who were indicated for advanced behavioral guidance.

Primary outcomes:
measure: Heart rate
timeFrame: through study completion, an average of 1 year
measure: Facial Image Scale
timeFrame: through study completion, an average of 1 year
measure: Vehnam Anxiety Rating Scale
timeFrame: through study completion, an average of 1 year
measure: Frankl behavior rating scale
timeFrame: through study completion, an average of 1 year
measure: FLACC Pain scale
timeFrame: through study completion, an average of 1 year
measure: Venham Scale of Dental behavior
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Abulaziz university dental hospital
state: Makkah
Study officials:
References: