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

NCT07375056 | Completed

• 1 other identifier: AU-ETHICS-2023-03-07
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Anxiety; Pain

Keywords

Therapeutic play; Virtual reality glasses; Local anesthesia; Pediatric dentistry

Outcome Measures

Primary Outcomes (3)

• Dental anxiety score measured by the Modified Child Dental Anxiety Scale (MCDAS)

  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

  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

  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 Outcomes (2)

• Heart Rate (beats per minute)

  Pre-anesthesia (before local anesthesia), Immediately after local anesthesia injection

• Oxygen Saturation (SpO₂)

  Pre-anesthesia (before local anesthesia), Immediately after local anesthesia injection

Study Arms (3)

Arm 1: Therapeutic Play Group

ACTIVE COMPARATOR

Therapeutic play intervention before local anesthesia

Device: Intervention 1: Therapeutic Play Group

Arm 2: Virtual Reality Glasses Group

ACTIVE COMPARATOR

Use of virtual reality glasses before local anesthesia

Behavioral: Intervention 2: Virtual Reality Glasses Group

Arm 3: Control Group

ACTIVE COMPARATOR

Routine local anesthesia without preparatory intervention

Other: control group

Interventions

Intervention 2: Virtual Reality Glasses Group BEHAVIORAL

Use of virtual reality glasses before local anesthesia

Arm 2: Virtual Reality Glasses Group

control group OTHER

Routine local anesthesia without preparatory intervention

Arm 3: Control Group

Intervention 1: Therapeutic Play Group DEVICE

Therapeutic play intervention before local anesthesia

Arm 1: Therapeutic Play Group

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University Faculty of Dentistry, Erzurum, Turkey

Erzurum, Türkiye, 34000, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Mehpare yener

  Ataturk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, Assistant Professor

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 29, 2026
• Study Start: May 2, 2023
• Primary Completion: June 30, 2023
• Study Completion: July 30, 2023
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)