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Completed

NCT Number: NCT07375056

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

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.

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Key information

Conditions

Dental Anxiety Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University Faculty of Dentistry, Erzurum, Turkey

Erzurum, Türkiye, 34000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. 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.

  2. 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.

  3. 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

  1. Heart Rate (beats per minute)

    Time frame: Pre-anesthesia (before local anesthesia), Immediately after local anesthesia injection

    Heart rate measured using a pulse oximeter

  2. Oxygen Saturation (SpO₂)

    Time frame: Pre-anesthesia (before local anesthesia), Immediately after local anesthesia injection

    Oxygen saturation (SpO₂, %) measured using a pulse oximeter.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 29, 2026
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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