Evaluation of Virtual Reality Based Distraction on Anxiety and Pain Perception in Paediatric Dental Extraction

NCT07693764 | Not Yet Recruiting

• 2 other identifiers: PED-VR-2026-AOMSBoard-2026
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Dental Anxiety in Children; Pain Perception

Keywords

pediatric dentistry; dental anxiety; tooth extraction; virtual reality; VR

Outcome Measures

Primary Outcomes (4)

• Child Dental Anxiety (Self-Report)

  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)

  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

  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)

  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

Secondary Outcomes (2)

• Pain Perception (Self-Report)

  at the end of the procedure

• Child Behavior (Observation)

  Time Points: Baseline (before the dental extraction procedure) and follow-up assessment at 1 month post-procedure

Study Arms (3)

Arm 1: Virtual Reality Distraction

EXPERIMENTAL

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

Device: Virtual reality headset

Arm 2: Audio-Visual Distraction

ACTIVE COMPARATOR

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.

Behavioral: Audio-visual distraction with 2D cartoons

Arm 3: Conventional Tell-Show-Do

ACTIVE COMPARATOR

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.

Behavioral: Tell-show-do with verbal distraction

Interventions

Virtual reality headset DEVICE

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.

Arm 1: Virtual Reality Distraction

Audio-visual distraction with 2D cartoons BEHAVIORAL

Children watch 2D cartoons with headset during dental extraction. This behavioral technique provides distraction to reduce dental anxiety and pain perception.

Arm 2: Audio-Visual Distraction

Tell-show-do with verbal distraction BEHAVIORAL

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.

Arm 3: Conventional Tell-Show-Do

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sultan Qaboos University: lead

Study Sites (2)

Sultan Qaboos University Hospital - Dental & Maxillofacial Department

Muscat, Oman

Location

The Medical City of Military and Security Service (Dental Center-AlKhoudh )

Muscat, Oman

Location

Related Publications (3)

• Barros Padilha DX, Veiga NJ, Mello-Moura ACV, Nunes Correia P. Virtual reality and behaviour management in paediatric dentistry: a systematic review. BMC Oral Health. 2023 Dec 12;23(1):995. doi: 10.1186/s12903-023-03595-7.

  PMID: 38087294 BACKGROUND

• Kasimoglu Y, Alpaycetin E, Ince G, Tuna Ince EB. Reduction of Dental Anxiety in Children Using Virtual Reality: A Randomised Controlled Trial. Eur J Paediatr Dent. 2025 Sep 1;26(3):185-191. doi: 10.23804/ejpd.2024.2109. Epub 2024 Oct 1.

  PMID: 39465519 BACKGROUND

• Gomez-Polo C, Vilches AA, Ribas D, Castano-Seiquer A, Montero J. Behaviour and Anxiety Management of Paediatric Dental Patients through Virtual Reality: A Randomised Clinical Trial. J Clin Med. 2021 Jul 7;10(14):3019. doi: 10.3390/jcm10143019.

  PMID: 34300185 BACKGROUND

Related Links

• Royal College of Surgeons of England. (n.d.). Non-pharmacological behavior management in dentistry. The Royal College of Surgeons of England.

Study Officials

• Dr. Azza Khalid AlSHidhani, DclinDent (Ed), MPaeds (RCSEd)

  Pediatric dental clinic , Dental and maxillofacial department (SQUH), University Medical City,

  STUDY DIRECTOR

• Dr. Khalifa Mohammed AlAzri, DclinDent (Ed), MPaeds (RCSEd)

  Pediatric dental clinic, Dental Center (Alkhoudh), The Medical City of Military and Security Services

  STUDY DIRECTOR

• Dr. Zamzam Ali Alqulhati, BDS, MFD(RCSI)

  Oman Medical Specialty Boaered

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr.Zamzam AlQulhati Ali AlQulhati, BDS, MFD ( RSCI)

CONTACT

+96895573313; zalqulhati@gmail.com

Azza AlShidhani Khalid AlShidhani, DclinDent (Ed), MPaeds (RCSEd)

CONTACT

+96895692669; azzak@squ.edu.om

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a three-arm, parallel group randomized controlled trial in children aged 6-10 years undergoing simple dental extraction. Participants are assigned to virtual reality distraction, audio-visual distraction, or conventional tell-show-do. The study is open-label with outcomes assessed at baseline, injection, extraction, and post-procedure.

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 9, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

OM (2)