---
title: Effect of Therapeutic Play and Virtual Reality Glasses on Pain and Anxiety in Children
nct_id: NCT07375056
overall_status: COMPLETED
phase: NA
sponsor: Ataturk University
study_type: INTERVENTIONAL
primary_condition: Dental Anxiety
countries: Turkey (Türkiye)
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07375056.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07375056"
ct_last_update_post_date: 2026-01-29
last_seen_at: "2026-05-12T07:08:45.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effect of Therapeutic Play and Virtual Reality Glasses on Pain and Anxiety in Children

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

**NCT ID:** [NCT07375056](https://clinicaltrials.gov/study/NCT07375056)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 66
- **Lead Sponsor:** Ataturk University
- **Conditions:** Dental Anxiety, Pain
- **Start Date:** 2023-05-02
- **Completion Date:** 2023-07-30
- **CT.gov Last Update:** 2026-01-29

## 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.

## 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.

## Eligibility

- **Minimum age:** 6 Years
- **Maximum age:** 9 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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
```

## Arms

- **Arm 1: Therapeutic Play Group** (ACTIVE_COMPARATOR) — Therapeutic play intervention before local anesthesia
- **Arm 2: Virtual Reality Glasses Group** (ACTIVE_COMPARATOR) — Use of virtual reality glasses before local anesthesia
- **Arm 3: Control Group** (ACTIVE_COMPARATOR) — Routine local anesthesia without preparatory intervention

## Interventions

- **Intervention 1: Therapeutic Play Group** (DEVICE) — Therapeutic play intervention before local anesthesia
- **Intervention 2: Virtual Reality Glasses Group** (BEHAVIORAL) — Use of virtual reality glasses before local anesthesia
- **control group** (OTHER) — Routine local anesthesia without preparatory intervention

## Primary Outcomes

- **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.
- **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.
- **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.

## Secondary Outcomes

- **Heart Rate (beats per minute)** _(time frame: 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)_

## Locations (1)

- Ataturk University Faculty of Dentistry, Erzurum, Turkey, Erzurum, Türkiye, Turkey (Türkiye)

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.ataturk university faculty of dentistry, erzurum, turkey|erzurum|türkiye|turkey (türkiye)` — added _(2026-05-12)_

---

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