Effectiveness of Puppet Modeling Technique on Children Undergoing Stressful Dental Procedures

Effectiveness of Puppet Modeling Technique on Children Undergoing Stressful Dental Procedures' Randomized Clinical Crossover Trial

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)

Study Overview

• Status: Completed
• Conditions: Behavioral Guidance in Pediatric Dentistry
• Intervention / Treatment: Behavioral: Tell Show and Do Guidance; Behavioral: Puppet Guidance

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Makkah
    • Jeddah, Makkah, Saudi Arabia, 21589
      • King Abulaziz university dental hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Children who received puppet behavior guidance during their first visit and tell-show-do guidance in their second visit, 2 weeks later. (P-TSD)	Behavioral: Tell Show and Do Guidance; In this technique, the dentist tells explains the procedure using the Tell show and do method.; Behavioral: Puppet Guidance; In this technique, the dentist using the puppet to explains the procedure.
Experimental: Group 2; 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)	Behavioral: Tell Show and Do Guidance; In this technique, the dentist tells explains the procedure using the Tell show and do method.; Behavioral: Puppet Guidance; In this technique, the dentist using the puppet to explains the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	The heart rate was measured throughout the procedure using Gibson finger oximeter. Three readings were recorded. One before the administration of local anesthesia, one during the injection and one immediately after.	through study completion, an average of 1 year
Facial Image Scale	The FIS comprises a row of five faces ranging from (1) very happy to (5) very unhappy. It is simple, efficient measure of anxiety in very young children than other measures of anxiety that depend on the cognitive ability of the child	through study completion, an average of 1 year
Vehnam Anxiety Rating Scale	The Vehnam Anxiety Rating Scale was used in this clinical trial to measure the patient's situational dental anxiety. This scale is an interval rating scale with the interval ranging from 0 (the least anxious score) to 5 (the most anxious	through study completion, an average of 1 year
Frankl behavior rating scale	It classifies child behavior into four groups according to the child's attitude during dental treatment: (4)Definitely positive, (3) Positive, (2) Negative, and (1) Definitely negative.	through study completion, an average of 1 year
FLACC Pain scale	Pain is assessed through observation of 5 categories including face, legs, activity, cry, and consolability. Each category will be given a score ranging from 0 to 2. The final score is calculated by adding up the scores of the five categories for a final score out of 10.	through study completion, an average of 1 year
Venham Scale of Dental behavior	The Venham Scale of Dental behavior is an interval rating scale with the interval ranking from 0 (extremely cooperative) to 5 (extremely uncooperative).	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: King Abdulaziz University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 16, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 16, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Pediatric dentistry; puppet; behavioral guidance; tell show and do
• Other Study ID Numbers: 247-05-21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No