NCT07736170

Brief Summary

The goal of this clinical trial is to learn if using a puppet in dental visits for children is an effective behavior guidance tool. The main questions it aims to answer are:

  • Does using a puppet to explain dental procedures to children during emergency dental visits lower their anxiety in a subsequent dental visit?
  • Does using a puppet to explain dental procedures to children during emergency dental visits improve their behavior in a subsequent dental visit? Researchers compared the effect of using a puppet to the traditional tell-show-do behavior guidance technique to see if the puppet is more effective in lowering their anxiety and improving their behavior. Participants were randomly allocated into two groups:
  • Group I: Children who received puppet play therapy in the emergency dental visit and in the subsequent dental visit.
  • Group II: Children who received only the traditional tell-show-do behavior guidance technique in the emergency dental visit and in the subsequent dental visit.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

1.4 years

First QC Date

July 22, 2026

Last Update Submit

July 25, 2026

Conditions

Keywords

behavior managementdental anxietypediatric dentistrypuppettell-show-do

Outcome Measures

Primary Outcomes (4)

  • Subjective Dental Anxiety as Assessed by Venham Picture Test (VPT) for Children Aged 3-5 Years

    The scale consists of eight pairs of images, each showing a child in both anxious and calm states. Children are asked to select one image from each pair that best represents how they feel. Each anxious image chosen is scored as one, while calm selections are scored as zero. The total dental anxiety score, which ranges from zero to eight, is calculated by summing the individual scores, with higher totals indicating greater anxiety.

    2 weeks after the intervention

  • Subjective Dental Anxiety as Assessed by Abeer Children Dental Anxiety Scale (ACDAS) for Children Aged 6-9 Years

    The scale is divided into three sections. Part A includes 13 self-reported items presented in a logical sequence, in which children indicate their feelings toward different dental situations using three facial expressions: happy/relaxed (score = 1), neutral/ "OK" (score = 2), and scared/anxious (score = 3). The total score ranges from 13 to 39; scores ≥26 indicate significant dental anxiety. Part B consists of three yes/no questions exploring the child's cognitive concerns, such as shyness about their teeth or dentist, and fear of losing control during treatment. Part C gathers additional information from both the parent/guardian and the dentist: parents report on the child's previous dental experiences and anticipated behavior, while the dentist records the child's behavior after treatment. By combining self-reported, parental, and clinical perspectives, ACDAS provides a comprehensive assessment of dental anxiety in children

    2 weeks after the intervention

  • Objective Dental Anxiety as Assessed by the Venham Anxiety Rating Scale (VARS)

    The VARS is constructed of six behaviorally defined categories that range from zero to five, with higher scores indicating higher levels of dental anxiety. The score gradually increases from relaxed (Score 0), to the child is totally out of control (Score 5). The target population for this scale is children aged 3-12 years.

    2 weeks after the intervention

  • Behavior as Assessed by the Behavior Profile Rating Scale (BPRS)

    An independent observer, other than the operating dentist, is required to systematically record the occurrence of 27 distinct behavioral aspects over a series of 3-minute intervals. Four of these behaviors assess the child's reaction to his separation from a parent. The remaining 23 aspects assess the child's behavior in the dental office. Each behavior is assigned a weighted score that reflects its level of disruptiveness. The total score is calculated by multiplying the frequency of each behavior during the 3-minute periods by its weight, then summing the results across all categories and dividing by the number of intervals. In this study, the BPRS was adapted to be applied once per quadrant during oral prophylaxis, rather than at fixed 3-minute intervals, because the procedure was short and, in some cases, did not extend to three minutes.

    2 weeks after the intervention

Secondary Outcomes (1)

  • Behavior as Assessed by the Frankl Behavior Rating Scale (FBRS)

    immediately after the procedure

Study Arms (2)

Puppet-aided TSD

EXPERIMENTAL

Children who received puppet-aided tell-show-do as a behavior guidance technique in the emergency dental visit.

Behavioral: Puppet Play Therapy

TSD

ACTIVE COMPARATOR

Children who received traditional tell-show-do as a behavior guidance technique in the emergency dental visit.

Behavioral: Tell-Show-Do (TSD)

Interventions

The investigator used the puppet to interact with the participants and explain the treatment in simple language before starting the dental procedure.

Also known as: Puppet Guidance
Puppet-aided TSD

Tell: The dentist explained what is about to happen using simple, age-appropriate language. Show: The dentist demonstrated the tool outside of the patient's mouth. Do: The dentist performed the procedure in the patient's mouth exactly as described.

TSD

Eligibility Criteria

Age3 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • healthy (including healthy children presenting with a localized dental abscess and no systemic involvement),
  • Arabic-speaking
  • and required emergency dental treatment under local anesthesia

You may not qualify if:

  • ASA II or higher according to the American Society of Anesthesiologists Physical Status Classification,
  • or if they required advanced behavior guidance, such as protective stabilization, during the emergency visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Abdulaziz University Dental Hospital

Jeddah, Saudi Arabia

Location

Related Publications (2)

  • Athanassiadou E, Giannakopoulos G, Kolaitis G, Tsiantis J, Christogiorgos S. Preparing the child facing surgery: The use of play therapy. Psychoanalytic social work. 2012;19(1-2):91-100.

    RESULT
  • Khogeer LN, Sabbagh HJ, Felemban OM, Farsi NM. Puppet play therapy in emergency pediatric dental clinic. A randomized clinical trial. BMC Pediatr. 2025 Jul 2;25(1):503. doi: 10.1186/s12887-025-05849-5.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assitant Professor

Study Record Dates

First Submitted

July 22, 2026

First Posted

July 30, 2026

Study Start

February 1, 2024

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

July 30, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

Data will be shared upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations