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

3. juli 2026 opdateret af: 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).

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

168

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Dr.Zamzam AlQulhati Ali AlQulhati, BDS, MFD ( RSCI)
  • Telefonnummer: +96895573313
  • E-mail: zalqulhati@gmail.com

Undersøgelse Kontakt Backup

  • Navn: Azza AlShidhani Khalid AlShidhani, DclinDent (Ed), MPaeds (RCSEd)
  • Telefonnummer: +96895692669
  • E-mail: azzak@squ.edu.om

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Enhed: 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.
Aktiv komparator: 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.
Adfærdsmæssigt: 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.
Aktiv komparator: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Child Dental Anxiety (Self-Report)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain Perception (Self-Report)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sultan Qaboos University

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

31. august 2027

Studieafslutning (Anslået)

1. oktober 2027

Datoer for studieregistrering

Først indsendt

24. juni 2026

Først indsendt, der opfyldte QC-kriterier

3. juli 2026

Først opslået (Faktiske)

9. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • PED-VR-2026-A
  • OMSBoard-2026 (Andet bevillings-/finansieringsnummer: Oman Medical Specialty Board)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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