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Evaluation of Virtual Reality Based Distraction on Anxiety and Pain Perception in Paediatric Dental Extraction (VR-PED)

3 de julho de 2026 atualizado por: Sultan Qaboos University

"Evaluation of Virtual Reality Based Distraction on Anxiety and Pain Perception in Paediatric Dental Extraction: A Randomized Controlled Trial"

The goal of this clinical trial is to learn if virtual reality distraction can reduce dental anxiety and pain perception in children aged 6-10 years undergoing simple dental extraction. The main questions it aims to answer are:

Does virtual reality distraction lower dental anxiety compared to audio-visual distraction and conventional tell-show-do techniques?

Does virtual reality distraction reduce pain perception during dental extraction?

Researchers will compare virtual reality distraction, audio-visual distraction (2D cartoons with headset), and conventional tell-show-do with verbal distraction to see which method is most effective in improving child cooperation and reducing anxiety and pain.

Participants will:

Wear VR glasses to watch immersive 3D cartoons, or

Watch 2D cartoons with headset, or

Receive the conventional tell-show-do technique with verbal distraction.

Outcome measures will include child dental anxiety (CFSS-DS, VCARS), pain perception (Wong-Baker FACES), physiological parameters (pulse rate, SpO₂), and behavioral cooperation (Frankl scale).

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

168

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Dr.Zamzam AlQulhati Ali AlQulhati, BDS, MFD ( RSCI)
  • Número de telefone: +96895573313
  • E-mail: zalqulhati@gmail.com

Estude backup de contato

  • Nome: Azza AlShidhani Khalid AlShidhani, DclinDent (Ed), MPaeds (RCSEd)
  • Número de telefone: +96895692669
  • E-mail: azzak@squ.edu.om

Locais de estudo

  • Omã
      • Muscat, Omã
        • Sultan Qaboos University Hospital - Dental & Maxillofacial Department
        • Contato:
          • Azza Khalid AlShidhani, DclinDent (Ed), MPaeds (RCSEd)
          • Número de telefone: +96895692669
          • E-mail: Azzak@squ.edu.om
        • Contato:
        • Subinvestigador:
          • Mohammed AlAzki, Diploma in Dental Surgery Assi
      • Muscat, Omã
        • The Medical City of Military and Security Service (Dental Center-AlKhoudh )
        • Contato:
        • Contato:
        • Subinvestigador:
          • Majid AlFori, Diploma in Dental Surgery Assi

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • Children aged 6 to 10 years
  • Classified as ASA class 1 or 2 (healthy or with mild systemic disease)
  • Those who demonstrated Frankl behavior rating 2 and 3 toward dental procedures
  • Children with NO previous exposure to invasive dental procedure
  • No prior experience using VR glasses
  • Requiring extraction of mandibular deciduous molar under local anesthesia

Exclusion Criteria:

  • ASA 3 and above
  • Those who demonstrated Frankl behavior rating 1 and 4 toward dental procedures
  • Special needs ( intellectual and developmental)
  • Children on psychotropic medication
  • Children wearing glasses
  • Presence of intra-oral swelling

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Arm 1: Virtual Reality Distraction
Children wear VR glasses to watch immersive 3D cartoons during dental extraction. Anxiety, pain, and cooperation are assessed using CFSS-DS, Wong-Baker FACES, VCARS, Frankl scale, and physiological parameters
Dispositivo: Virtual reality headset
Children wear a virtual reality headset to watch immersive 3D cartoons during dental extraction. This device provides distraction to reduce dental anxiety and pain perception.
Comparador Ativo: Arm 2: Audio-Visual Distraction
Children watch 2D cartoons with headset during dental extraction. Anxiety, pain, and cooperation are measured using the same scales and physiological parameters as the VR group.
Comportamental: Audio-visual distraction with 2D cartoons
Children watch 2D cartoons with headset during dental extraction. This behavioral technique provides distraction to reduce dental anxiety and pain perception.
Comparador Ativo: Arm 3: Conventional Tell-Show-Do
Children receive the standard tell-show-do technique with verbal distraction during dental extraction. Anxiety, pain, and cooperation are assessed using CFSS-DS, Wong-Baker FACES, VCARS, Frankl scale, and physiological parameters.
Comportamental: Tell-show-do with verbal distraction
Children receive the standard tell-show-do technique with verbal distraction during dental extraction. This behavioral method is used to reduce dental anxiety and improve cooperation.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Child Dental Anxiety (Self-Report)
Prazo: Time Points: Baseline (before starting the procedure) and post-operative assessments ( after finishing the extraction)
Change in child dental anxiety will be measured using the Children's Fear Survey Schedule - Dental Subscale (CFSS-DS, Arabic version). The CFSS-DS consists of 15 items, each scored from 1 (not afraid) to 5 (very afraid), yielding a total score range of 15 to 75. Higher scores indicate greater dental anxiety (worse outcome). The unit of measure is the CFSS-DS score.
Time Points: Baseline (before starting the procedure) and post-operative assessments ( after finishing the extraction)
Child Dental Anxiety (Observation-based Assessment)
Prazo: Time points: This scale will be measured at 4 time points during the procedure: T0(baseline)= 15 min before starting the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 mins after the extraction
Change in child dental anxiety will also be assessed using Venham's Clinical Anxiety Rating Scale (VCARS). This observational scale is scored from 0 (relaxed) to 5 (out of control), with a total score range of 0 to 5. Higher scores indicate greater observed anxiety (worse outcome).
Time points: This scale will be measured at 4 time points during the procedure: T0(baseline)= 15 min before starting the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 mins after the extraction
3a: Physiological Monitoring - Pulse Rate
Prazo: Will be measured at 4 time points: T0 ( Baseline)= 15 minutes before the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 minutes after extraction

Pulse rate will be monitored using a pulse oximeter. The unit of measure is beats per minute (bpm). In children, the normal resting pulse rate varies by age:

Preschool children (3-5 years): ~80-120 bpm

School-aged children (6-12 years): ~70-118 bpm

Adolescents (13-18 years): ~60-100 bpm Higher values during the dental procedure indicate greater physiological arousal (worse outcome).
Will be measured at 4 time points: T0 ( Baseline)= 15 minutes before the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 minutes after extraction
3b: Physiological Monitoring - Oxygen Saturation (SpO₂)
Prazo: Will be measured at 4 time points: T0 ( Baseline)= 15 minutes before the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 minutes after extraction
Oxygen saturation will be monitored using a pulse oximeter. The unit of measure is percentage (%). In healthy children, normal SpO₂ values are typically 95-100% at rest. Lower values indicate poorer physiological status (i.e., worse outcomes).
Will be measured at 4 time points: T0 ( Baseline)= 15 minutes before the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 minutes after extraction

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Pain Perception (Self-Report)
Prazo: at the end of the procedure
Self-reported pain perception will be measured using the Wong-Baker FACES Pain Rating Scale (Arabic version). This scale ranges from 0 (no pain) to 10 (worst pain), represented by facial expressions. Higher scores indicate greater pain intensity (worse outcome), and lower scores indicate less pain intensity (better outcome)
at the end of the procedure
Child Behavior (Observation)
Prazo: Time Points: Baseline (before the dental extraction procedure) and follow-up assessment at 1 month post-procedure

Child behavior will be assessed using the Frankl Behavior Rating Scale. This scale has four degrees:

  1. (Definitely Negative): Refusal of treatment, forceful crying, fearfulness, or extreme negativism.
  2. (Negative): Reluctant to accept treatment, uncooperative, some negative attitude but not pronounced.
  3. (Positive): Acceptance of treatment, cautious behavior, willingness to comply with the dentist, sometimes with reservation.
  4. (Definitely Positive): Good rapport with the dentist, interested in dental procedures, laughing and enjoying the situation.

The total score range is 1 to 4. Higher scores indicate more cooperative behavior (better outcome).
Time Points: Baseline (before the dental extraction procedure) and follow-up assessment at 1 month post-procedure

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Sultan Qaboos University

Investigadores

  • Diretor de estudo: Dr. Azza Khalid AlSHidhani, DclinDent (Ed), MPaeds (RCSEd), Pediatric dental clinic , Dental and maxillofacial department (SQUH), University Medical City,
  • Diretor de estudo: Dr. Khalifa Mohammed AlAzri, DclinDent (Ed), MPaeds (RCSEd), Pediatric dental clinic, Dental Center (Alkhoudh), The Medical City of Military and Security Services
  • Investigador principal: Dr. Zamzam Ali Alqulhati, BDS, MFD(RCSI), Oman Medical Specialty Boaered

Publicações e links úteis

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Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de setembro de 2026

Conclusão Primária (Estimado)

31 de agosto de 2027

Conclusão do estudo (Estimado)

1 de outubro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

24 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de julho de 2026

Primeira postagem (Real)

9 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • PED-VR-2026-A
  • OMSBoard-2026 (Número de outro subsídio/financiamento: Oman Medical Specialty Board)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Individual participant data (IPD) will not be shared due to ethical considerations in pediatric populations, privacy concerns, and institutional policy. Only aggregated results will be published in peer-reviewed journals and presented at scientific meetings.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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