NCT07034833

Brief Summary

thhe goal of this clinical trial is to assess the effect of ventriloquist puppets to reduce the strees accompined by the dental visit in cgilren . The main questions it aims to answer are:

  • Does the ventriloquist puppet can reduce the stress accompanied by the dental visit for the children ?
  • What medical problems do participants have when taking drug ABC? Researchers will compare ventriloquist puppet to a control group (conventional behavior management techniques ) to see if ventriloquist puppet can lower the anxiety or not.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

May 22, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

June 23, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2025

Completed
Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

8 days

First QC Date

May 22, 2025

Last Update Submit

June 15, 2025

Conditions

Keywords

dental anxietybehavior management

Outcome Measures

Primary Outcomes (2)

  • Dental anxiety

    Change in Anxiety Score using MCDAS scale

    From immediately before to immediately after the dental procedure

  • Heart rate

    change in heart rate during the visit to investigate the anxiety effect using pulse oximeter

    From immediately before to immediately after the dental procedure

Study Arms (2)

control group: 25 child managed by basic behavior management tecniques

NO INTERVENTION

this group managed normaly with the basic behavior managment techniques like tell , show , do and others

puppet therapy group: Children allocated to the Ventriloquist Puppet group

ACTIVE COMPARATOR

Children allocated to the Ventriloquist Puppet group were introduced to a Ventriloquist Puppet inside the clinic and were allowed to play , talk and interact with the puppet for five to 10 min

Behavioral: Ventriloquist Puppet Interaction

Interventions

children allocated to the Ventriloquist Puppet group were introduced to a Ventriloquist Puppet inside the clinic and were allowed to play, talk, and interact with the puppet for 5-10 minutes.

puppet therapy group: Children allocated to the Ventriloquist Puppet group

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • healthy children with no systemic diseases.
  • children require dental intervention

You may not qualify if:

  • children with bad dental experience
  • children require invasive surgical intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of pediatric dentistry and oral health

Study Record Dates

First Submitted

May 22, 2025

First Posted

June 24, 2025

Study Start

June 23, 2025

Primary Completion

July 1, 2025

Study Completion

July 10, 2025

Last Updated

June 24, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share