Effect of Therapeutic Play and Virtual Reality Glasses on Pain and Anxiety in Children

January 21, 2026 updated by: Mehpare Yener, Ataturk University

The Effect of Therapeutic Play and Virtual Reality Glasses on Pain and Dental Anxiety Before Local Anesthesia in Children: A Randomized Controlled Trial

Background: A child's first dental experience plays a crucial role in treatment success and in fostering cooperation during future visits. In pediatric dentistry, various non-pharmacological approaches have been implemented to prepare children for dental procedures. This study aims to evaluate the effects of two such approaches-therapeutic play and virtual reality glasses-designed to familiarize children with dental instruments, on pain perception and dental anxiety.

Methods: A total of 66 healthy children aged 6-9 years attending their first dental visit at the Pediatric Dentistry Clinic of Ataturk University will be included. Participants will be randomly assigned into three groups: one group will receive therapeutic play before local anesthesia; the second group will use virtual reality glasses before local anesthesia; and the control group will receive local anesthesia without any preparatory intervention. Dental anxiety and pain will be assessed using the Modified Children's Dental Anxiety Scale (MCDAS), the Wong-Baker FACES Pain Rating Scale (WBS), and the FLACC scale. Physiological parameters including heart rate and oxygen saturation will be recorded before and after anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Children often experience dental anxiety during their first dental visit, particularly before local anesthesia. Non-pharmacological approaches such as therapeutic play and virtual reality distraction may help reduce anxiety and pain perception. This randomized controlled trial compared the effectiveness of therapeutic play and virtual reality glasses with routine care in reducing dental anxiety and pain in children aged 6-9 years. Anxiety was assessed using the Modified Children's Dental Anxiety Scale, pain was evaluated using the Wong-Baker FACES Pain Rating Scale and FLACC scale, and physiological parameters were recorded.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Türkiye
      • Erzurum, Türkiye, Turkey (Türkiye), 34000
        • Ataturk University Faculty of Dentistry, Erzurum, Turkey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Children aged 6 to 9 years
  • Attending their first dental visit
  • Participation voluntarily approved by both the child and the parent or legal guardian

Exclusion Criteria:

  • Presence of acute dental pain
  • Presence of systemic health problems
  • Allergy to the modeling compound used in the playset
  • Any visual or auditory impairment that could interfere with the use of virtual reality glasses

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1: Therapeutic Play Group
Therapeutic play intervention before local anesthesia
Device: Intervention 1: Therapeutic Play Group
Therapeutic play intervention before local anesthesia
Active Comparator: Arm 2: Virtual Reality Glasses Group
Use of virtual reality glasses before local anesthesia
Behavioral: Intervention 2: Virtual Reality Glasses Group
Use of virtual reality glasses before local anesthesia
Active Comparator: Arm 3: Control Group
Routine local anesthesia without preparatory intervention
Other: control group
Routine local anesthesia without preparatory intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dental anxiety score measured by the Modified Child Dental Anxiety Scale (MCDAS)
Time Frame: Baseline (before intervention), Pre-anesthesia (before local anesthesia), Immediately after local anesthesia injection
Dental anxiety assessed using the Modified Child Dental Anxiety Scale (MCDAS), a validated questionnaire consisting of 8 items. Total scores range from 8 to 40, with higher scores indicating higher dental anxiety.
Baseline (before intervention), Pre-anesthesia (before local anesthesia), Immediately after local anesthesia injection
Pain score measured by the Wong-Baker FACES Pain Rating Scale
Time Frame: Baseline (before intervention), Pre-anesthesia (before local anesthesia), Immediately after local anesthesia injection
Pain intensity assessed using the Wong-Baker FACES Pain Rating Scale, with scores ranging from 0 to 10, where higher scores indicate more severe pain.
Baseline (before intervention), Pre-anesthesia (before local anesthesia), Immediately after local anesthesia injection
Pain score measured by the FLACC scale
Time Frame: Baseline (before intervention), Pre-anesthesia (before local anesthesia), Immediately after local anesthesia injection
Pain intensity assessed using the FLACC scale (Face, Legs, Activity, Cry, Consolability), with scores ranging from 0 to 10, where higher scores indicate more severe pain.
Baseline (before intervention), Pre-anesthesia (before local anesthesia), Immediately after local anesthesia injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate (beats per minute)
Time Frame: Pre-anesthesia (before local anesthesia), Immediately after local anesthesia injection
Heart rate measured using a pulse oximeter
Pre-anesthesia (before local anesthesia), Immediately after local anesthesia injection
Oxygen Saturation (SpO₂)
Time Frame: Pre-anesthesia (before local anesthesia), Immediately after local anesthesia injection
Oxygen saturation (SpO₂, %) measured using a pulse oximeter.
Pre-anesthesia (before local anesthesia), Immediately after local anesthesia injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Investigators

  • Principal Investigator: Mehpare yener, Ataturk University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Rajeswari SR, Chandrasekhar R, Vinay C, Uloopi KS, RojaRamya KS, Ramesh MV. Effectiveness of Cognitive Behavioral Play Therapy and Audiovisual Distraction for Management of Preoperative Anxiety in Children. Int J Clin Pediatr Dent. 2019;12(5):419-22.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2023

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

July 30, 2023

Study Registration Dates

First Submitted

December 29, 2025

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AU-ETHICS-2023-03-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Intervention 1: Therapeutic Play Group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe