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

3 de julio de 2026 actualizado 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).

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

168

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Dr.Zamzam AlQulhati Ali AlQulhati, BDS, MFD ( RSCI)
  • Número de teléfono: +96895573313
  • Correo electrónico: zalqulhati@gmail.com

Copia de seguridad de contactos de estudio

  • Nombre: Azza AlShidhani Khalid AlShidhani, DclinDent (Ed), MPaeds (RCSEd)
  • Número de teléfono: +96895692669
  • Correo electrónico: azzak@squ.edu.om

Ubicaciones de estudio

  • Omán
      • Muscat, Omán
        • Sultan Qaboos University Hospital - Dental & Maxillofacial Department
        • Contacto:
          • Azza Khalid AlShidhani, DclinDent (Ed), MPaeds (RCSEd)
          • Número de teléfono: +96895692669
          • Correo electrónico: Azzak@squ.edu.om
        • Contacto:
          • Mohammed AlAzki, DSA
          • Número de teléfono: +968-97674606
          • Correo electrónico: m.alazki@squ.edu.om
        • Sub-Investigador:
          • Mohammed AlAzki, Diploma in Dental Surgery Assi
      • Muscat, Omán
        • The Medical City of Military and Security Service (Dental Center-AlKhoudh )
        • Contacto:
        • Contacto:
        • Sub-Investigador:
          • Majid AlFori, Diploma in Dental Surgery Assi

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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 activo: 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.
Conductual: 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 activo: 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.
Conductual: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Child Dental Anxiety (Self-Report)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Pain Perception (Self-Report)
Periodo de tiempo: 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)
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Sultan Qaboos University

Investigadores

  • Director de estudio: Dr. Azza Khalid AlSHidhani, DclinDent (Ed), MPaeds (RCSEd), Pediatric dental clinic , Dental and maxillofacial department (SQUH), University Medical City,
  • Director de estudio: 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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

31 de agosto de 2027

Finalización del estudio (Estimado)

1 de octubre de 2027

Fechas de registro del estudio

Enviado por primera vez

24 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

3 de julio de 2026

Publicado por primera vez (Actual)

9 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • PED-VR-2026-A
  • OMSBoard-2026 (Otro número de subvención/financiamiento: Oman Medical Specialty Board)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan 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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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