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Completed

NCT Number: NCT06964451

Assessing the Effect of Virtual Reality Gamification on Anxiety and Pain Management During Extraction of MIH-affected Lower First Permanent Molars in Pediatric Patients

The aim of this study was to evaluate the effectiveness of gamified virtual reality in reducing anxiety and pain during the extraction of lower first molars with MIH under local anaesthesia.

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Key information

Conditions

Virtual Reality Distraction Gamification Tooth Extraction

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty od Medical Sciences University of Kragujevac

Kragujevac, 34000, Serbia

About this study

Dental anxiety can be tiggered by previous negative experiences, fear of pain, or loss of control, leading to avoidance of dental treatments and worsening oral health. To alleviate anxiety, various pharmacological and non-pharmacological measures are applied, including distraction as a cognitive-behavioral approach. One innovative method of distraction is gamification, which involves the use of Virtual Reality (VR) to redirect patients' focus to something relaxing instead of the treatment itself. The aim of this research was to evaluate the effectiveness of gamified virtual reality in reducing anxiety and pain during the extraction of molar-incisal hypomineralization (MIH) affected lower first molars under local anaesthesia. In prospective study, gamified virtual reality was applied during the extraction of lower first molars in 56 subjects using the split-mouth method. Through VR goggles, patients were immersed in a virtual video game world to distract them from the dental procedure.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Indication for the extraction of both lower first molars due MIH grade 4.

Exclusion criteria

  • Exclusion criteria for the study encompassed individuals with systemic disease, special needs, patients with a history of epileptic seizures or episodes of dizziness, as well as patients suffering from claustrophobia.

Treatment and study plan

Extraction tooth

Procedure

Extraction of MIH Grade 4 molar

Primary outcomes

  1. Face Scale

    Time frame: 1 day

    We used the Wong-Baker Face Scale to assess pain, which allows patients to visually describe their level of pain. This scale consists of six faces with different expressions, ranging from a face showing no pain to a face representing the worst possible pain. This method of assessment is particularly useful for children. Pain was recorded during the administration of anaesthesia and during the tooth extraction procedure

  2. Heart rate

    Time frame: 1 day

    Additionally, heart rate was monitored to assess the patient's physiological response to stress and pain during the procedure. Heart rate was recorded during anaesthesia administration and during the procedure using a smartwatch that allows continuous heart rate tracking (Samsung Galaxy Watch). This type of measurement provides additional information on how the patient responds to pain and stress, enabling the dentist to adjust their approach according to the patient's physiological response.

Secondary outcomes

  1. Satisfaction questionnaire

    Time frame: 1 day

    After the extraction procedure with VR application, patients filled out a modified satisfaction questionnaire. Responses were classified based on a 5-point Likert scale: 1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, and 5 = strongly agree. The post-clinical questionnaire included questions related to reduction of fear of anaesthesia and extraction, effectiveness of VR in diverting attention from the procedure, experience of discomfort during the procedure, enjoyment of the VR experience, and the potential of VR in overcoming fear of other procedures.

Sponsors and collaborators

Lead sponsor

Rasa Mladenovic

Other

Registry information

Acronym: VRGAMIFICATION

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 9, 2025
Registry last updated
May 9, 2025

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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